StemCell Therapy

In this new eraof the renaissance ofnon-penetrating glaucoma surgeries, newer implants, and shunt procedures, the role of trabeculectomy (TRAB) as the gold standard of glaucoma procedures is ambivalent. Even though many practitioners claim that TRAB will not survive in the near future, it still remains the first choice for most glaucoma surgeons. in cases with advanced damage, rapid progression despite maximal medical therapy, and in patients where the target intraocular pressure (IOP) required is very low. 'Trabeculectomy' procedure reported by Cairns in 1968 has undergone various modifications to increase outflow and achieve long-term success [1]. But the main issues with TRAB include short and long-term complications like hypotony, hypotonic maculopathy, wipe-out phenomenon, bleb leaks, cataracts, choroidal effusion, and hemorrhage [2]. These complications are accelerated with the concomitant use of anti-fibrotic, but without them, the chances of short-term failure are also relatively high [3,4].The advent of novel minimally invasive glaucoma surgeries (MIGS) and non-penetrating surgeries (NPGS) have paved the path for lesser complicated yet effective ways of controlling IOP [5-8]. This review article summarizes the evolution and modifications of TRAB and its comparison of efficacy with neoteric shunt procedures while trying to answer whether TRAB has a future in the modern surgical world.

Glaucoma surgery now encompasses a variety of surgeries apart from conventional trabeculectomy (Figure 1).

Trabeculectomy underwent significant changes from an initial sclerotomy toan anterior sclerotomy, latera sclerectoiridectomy in 1906 orlimbal trephination andiridencleisis to provide a permanent fistula by using iris as a wick between the anterior chamber and the subconjunctival space [2]. This was modifiedwith a peripheral iridectomy and thermal sclerostomy (1958), or posterior lip sclerectomybefore guarded filtration surgeries were introduced to offset the catastrophic complications with full-thickness procedures[2,8,9].

Cairns JE initially described trabeculectomy in 1968 [1] that was later modified by Watson in 1970 [10,11]. Over the years, it has undergone modifications and supplementations to improve long-term success and reduce complications. Cairns described TRAB as a bypass procedure of making a deep scleral flap with excision of a small segment of the canal of Schlemm with trabecular tissue, Removal of the trabecular barrier at that point thus allowed an alternative resistance-free pathway. Few clinicians consider the namea misnomer, as cutting mainly the Schlemm's canal and adjoining corneal tissue will also serve the purpose, and clearing the trabecular tissue alone is not mandatory [11].But the initial procedure was associated with complications of a full-thickness procedure and had high rates of failure [3,4,10-12].

Early trabeculectomy filtering procedures were associated with a high rate of complications like hypotony, hypotonic maculopathy, choroidal detachment, suprachoroidal hemorrhage, bleb-related infections, and endophthalmitis [12-18]. Early cases of bleb leaks, shallow anterior chamber, and hypotony can be resolved with the use of large bandage contact lenses, pressure patching, symblepharon rings, and the Simmons shell. However, a flat anterior chamber with lens-corneal touch requires immediate surgical intervention to prevent rapid cataract development and irreversible corneal endothelial damage [12-14]. Initial studies have reported hypotony and choroidal detachment as late as 2-26 months following primary uncomplicated surgery that warrants a repeat surgery [14,15]. These complications forced surgeons to search for newer surgeries or ways to increase the safety profile while not compromising on the surgical success of trabeculectomy.

Watson and Barnett later modified this procedure by making a 5 x 5 mm partial-thickness flap and making a corneoscleral window for the passage of aqueous humor [10]. The original TRAB technique described by Cairns never intended to make a drainage bleb, but later it was observed that cases with good bleb had a higher success rate. It was then that the focus shifted to considering TRAB as a filtration surgery, and more attention was focused on the surgical techniques, which facilitated the creation of diffuse drainage blebs [16-18]. In the late 1960s, in order to create a track between the subconjunctival space and the anterior chamber, various methods of ab-interno and ab-externo approaches were tried using pulsed Nd: YAG laser, carbon dioxide laser, and excimer laser [16-19]. However, higher failure rates with laser surgeries make TRAB the standard procedure of choice for ensuring long-term success [19]. Newer procedures with comparable IOP outcomes are still evolving and are yet to replace TRAB as the gold standard for preservation of visual function in early-moderate glaucoma and more so for advanced stages of glaucoma, where TRAB still remains the surgery of choice.

Antifibrotics to the Rescue

Increased use of anti-fibrotic agents like mitomycin C (MMC) and 5-fluorouracil (5-FU) along with TRAB started in the early 1990s to enhance the success rate, long-term survival rate, and decrease the progression of glaucoma [15,19-26]. In recent years, the use of MMC has significantly increased, while that of 5-FU has declined as a preferred practice pattern for primary TRAB [19-22]. A United Kingdom surveyrecently reported the use of anti-fibrotic agents in primary TRAB in 93% of their cases, of which63% used 5-FU and 97% used MMC[20]. Various doses and duration of MMC use have been tried to offset delayed complications like bleb thinning, bleb leaks, or endophthalmitis. The American Glaucoma Society survey in 2016, claimed the dosage of MMC as 0.4 mg/mL (ranging from 0.2 to 0.5 mg/mL) applied for 2 minutes (range 45s-3 minutes) for primary TRAB, as the most popular and safer method[20]. Considering the role of angiogenesis in TRAB failure by wound modulation, the use of anti-VEGF agents is being tried in place of antifibrotics in TRAB. Liu et al. [21] reviewed eight randomized control trials (RCT) on TRAB with bevacizumab and concluded that bevacizumab and MMC had similar efficacy in IOP reduction. However, bevacizumab has been associated with a higher risk of leaking bleb and encystation, withother major issues being cost-effectiveness and off-label use [22]. The most recent RCT on intracameral bevacizumab in TRAB showed comparable surgical efficacy and IOP reduction to MMC, but with an increased rate of bleb leaks [23]. Recently the use of Ologen collagen matrix has been found to effectively modulate fibrous tissue formation thus decreasing the chances of failure[24,25]. Few surgeons have also tried using a combination of Ologen and MMC, with encouraging results [25]. A five-year follow-up study comparing Ologen to MMC also showed comparable results in both efficacy and safety between the two groups [26]. However, the cost of the Ologen implant is a major limiting factor for developing countries.

How Trabeculectomy Lost the Battle

Though TRAB success rates improved with the use of antifibrotics, the rates of delayed complication rates also increased parallelly, which again questioned the efficacy of TRAB as a standard glaucoma filtering surgery [15-18,27-30]. Belyea et al. studied 385 eyes that underwent TRAB with antifibrotics (MMC and 5-FU) and found an incidence of late repetitive multifocal bleb leaks in 1.8% of the eyes [15]. The incidence was equal among the two antifibrotics according to their study. The median period of the presentation was 20 months post-surgery.Singh et al. [27] studied the complications associated with the use of 0.2 mg/ml of MMC in TRAB and reported late bleb leaks, scleral necrosis, and hypotonic maculopathy as the major complications. It is now understood that their use results in the formation of thin and avascular blebs even in the delayed postoperative period, paving way for the easier migration of pathogens across the bleb and increased chance of delayed-onset endophthalmitis and blebitis. Incidence of bleb relation infection with MMC TRAB procedures reduced from 5.7% to 1.2% after the 1990s, after the introduction of MMC into clinical practice [28]. A recent study by Vaziri et al. [29] reported the incidence of endophthalmitis post trabeculectomy to be 0.45 0.2% for confirmed cases and 1.3 0.34% for confirmed plus presumed cases. The most common microbiological flora isolated from eyes with bleb-related infections includes Staphylococcus aureus, coagulase-negative staphylococci, Corynebacterium, and Haemophilus influenza [30].

Safe TRABRe-emergence and Renewal

Since there was an increasing understanding of the causes of MMC-related bleb complications, safer techniques were now sought to prevent these delayed complications [15,18,30-31]. Khaw et al. [31]. designed a range of strategies commonly known as Moorfield's safe surgery techniques to improve the control of IOP as well as to preserve visual acuity by minimizing bleb-related complications and hypotony. Three major objectives in the adoption of the technique include:1) prevention of hypotony; 2) prevention of thin uncomfortable cystic blebs and 3) prevention of limbal leaks of aqueous. Various steps adopted to prevent hypotony include a fornix-based conjunctival flap, making a small sclerotomy punch, continuous intraoperative anterior chamber infusion to achieve optimal pressure titration and to prevent hypotony, posterior placement of the MMC loaded sponges ensuring posterior flow, avoidance of >3minutes of MMC application at any single time, and a thorough wash of the area after each application. To prevent cystic uncomfortable blebs, selection of a superior location under the eyelid, larger area of treatment, fornix-based flap to minimize posterior scarring, and posterior diversion of aqueous by altering scleral flap construction, are some useful measures for safer TRAB with lower complication rates. Adopting a corneal groove-closure technique also helps in preventing limbal leaks of aqueous. Adoption of these techniques reduced the delayed complication rates associated with MMC use and this ushered in a resurgence of TRAB in glaucoma until the advent of technologically assisted filtering procedures [31].

Minimally Invasive Glaucoma Surgery (MIGS)

Those procedures wherein the trabecular meshwork (TM) is incised /excised under direct supervision using specialized instruments are called ab-Interno or microinvasive glaucoma surgery [32-38]. These include the usage of trabectome, kahook dual blade, microhook ab-interno trabeculectomy, gonioscopy assisted transluminal trabeculotomy (GATT, Figure 2A), ab-interno goniotomy (Figure 2B), and ab-interno trabeculotomy 360 degrees. These are usually not associated with a bleb, require smaller incisions of entry, and are therefore not associated with bleb-related complications (Figures 1-2).A meta-analysis found the success rate of trabectome alone to be 46%, and when combined with phacoemulsification to increase to 85%, both achieving >30% IOP reduction [32]. With gonioscopy-assisted transluminal trabeculotomy (GATT), results have shown an IOP decrease of approximately 7.7 mmHg and 11.1 mmHg at 6 and 12 months, respectively. The number of anti-glaucoma medications (AGMs) reduced by 0.9 and 1.1 on average at 6 and 12 months [33].Similarly, trabeculotomy 360 procedures performed on patients with refractory primary open-angle glaucoma (POAG) reported a 20% IOP reduction in 59% of patients, with the average number of anti-glaucoma medications dropping from 1.7 1.3 to 1.1 1.0 medications [34]. However, this had a 25% failure rate, with the majority requiring a second procedure within 12 months. Another study comparing ab-interno trabeculectomy with trabectome with ab-externo trabeculectomy found a lower success rate (22.4% Vs 76.1%), with 43.5 % requiring a second procedure for effective IOP control [35]. Even now, these procedures are used for moderate to early glaucoma, while TRAB remains the time-tested surgery for advanced glaucoma. Further, none of these procedures have been reported to offer long-term preservation of visual function better than TRAB or to be cost-effective for the patient in developing countries.

Non-penetrating glaucoma surgeries (NPGS)

Metanalysis comparing TRAB and non-penetrating glaucoma surgeries (NPGS) has concluded that TRAB results in much better control of IOP than NPGS [28-32].Though the complications rates with TRAB are higher, it is preferablein cases with advanced chronic glaucoma and pseudoexfoliation glaucoma, where NPGS offers a lower success rate[32]. In 1964, Krasnov published his first report on a novel technique called "sinusotomy," which consisted of removing a lamellar band of the scleraand opening the Schlemm's canal over 120 [36]. He believed that the aqueous outflow resistance was mainly at the level of scleral aqueous drainage veins and not in the trabecular meshwork. Hence, no superficial scleral flap covered the sclerectomy in this technique. However, the sinusotomy procedure was eventually abandoned due to the difficult learning curve and less reduction in IOP compared with TRAB.

In 1989, Fyodorov and Kozlov described another technique called deep sclerectomy. In this procedure, careful scraping of the Schlemm's canal bed is done to remove a homogenous "external trabecular membrane" that allows aqueous humor to exit through the remaining inner trabecular layers [37]. Later in 1999, Stegmann et al. [38] reported 'viscocanalostomy' where a high molecular weight viscoelastic substance is injected into the opening of Schlemm's canal to enlarge the canal. This procedure allows the aqueous to bypass the juxtacanalicular trabecular meshwork and also drains the aqueous from the exposed Descemet's window. These surgeries were designed as a safer alternative to reduce complications of a full penetrating procedure while allowing filtration through the Schlemm's canal.

Micro-invasive glaucomaimplants, targeting the conventional outflow pathway, have emerged in the field of glaucoma over the last two decades to address an unmet need for better therapeutic options [32-45]. Various approaches have been adopted by these procedures to bring down the IOP by directly bypassing the trabecular meshwork, dilating the Schlemm's canal, and enhancing the uveoscleral outflow by assessing the suprachoroidal space and decreasing the aqueous production by ablating the ciliary body. One study reported a mean reduction of 7.0 4.0 mmHg withI-stent combined with phacoemulsification versusa mean IOP reduction of 5.4 3.7 mmHg with phacoemulsification alone, with 84% of the former eyes being medication free [39]. Another trialevaluated the safety and efficacy of CyPass stunt (ab-interno-supraciliary space shunt) and reported a higher reduction of IOP (77% vs 66%) in eyes that underwent stent implantation along with cataract surgery. Furthermore, 85% of eyes in the CyPass group were medication-free at two years [40]. However, the device was later withdrawn due to certain safety concerns over follow-up [41]. Gabbay and Ruben did a retrospective analysis on the safety of CyPass stents and reported few other adverse effects over a short follow-up like postoperative pressure sikes (28%), hyphema, vitreous hemorrhage, choroidal effusion, and retinal detachment [42].A hydrogel implant (XEN) is a newer FDA-approved implant that helps in shunting aqueous outflowinto the subconjunctival space. Studies have reported a >20% reductionin IOP in 75.4% of patients, with a decrease in an average number of AGMs from 3.5to 1.7 at 12 months postoperatively [43]. Studies comparing the latest XEN implant to conventional TRAB have claimed a higher and more efficacious IOP reduction with TRAB[44,45]. Though MIGS is now recognized as an alternative to TRAB, the major concerns include the steep learning curveand the varying safety profiles of different surgical procedures. Further, the cost-effectiveness, need for sophisticated machinery and instruments, and the need for frequent follow-up/additional surgeries, questions the actual effectiveness for visual function and the long-term applicability of these procedures worldwide.

TRAB Versus Lensectomy

Since cataract extraction alone was reported to cause IOP reduction, TRAB has been compared with cataract extraction alone in POAGand primary angle-closure glaucoma (PACG) [46-57]. Tham et al. [46] compared phacoemulsification (PHACO) alone to TRAB with MMC in medically uncontrolled angle-closure glaucoma without cataracts. Both groups resulted in significant and comparable IOP reduction at 24 months after surgery (IOP reduction of 34% for PHACO alone vs. 36% for TRAB+MMC, {P=0.76}). Nevertheless, TRAB+MMC-treated eyes required fewer AGMs than PHACO alone eyes.The same group studied the effect of combined phaco trabeculectomy (PT) to phacoemulsification alone (PHACO) and claimed that the former procedure is more effective than PHACO alone group in controlling IOP in medically uncontrolled chronic angle closure glaucoma eyes with coexisting cataract [47]. However, the PT group was associated with more surgical complications. An analogous study on POAG patients was done by Takihara et al. [49] and they concluded that TRAB with MMC in pseudophakic eyes post phacoemulsification is less successful compared with that in phakic eyes. However, no significant intergroup difference was noted in the number of postoperative antiglaucoma medications, surgical complications or in the number of laser suture lysis procedures.

TRAB Combined Cataract and Glaucoma Surgery

There had been numerous studies comparing TRAB with phaco trabeculectomy with anecdotal results(Table 1) [50-57].However, a recent metanalysis on phaco trabeculectomy (PT) versus TRAB (TRAB) with or without later phacoemulsification did not find a significant difference in IOP reduction between the two procedures. A total of 25 studies were included comprising2315 eyes that underwent PT and 2216 eyes that underwent TRAB, wherein, PT was associated with a lower risk of postoperative complications and better best-corrected visual acuity (BCVA) compared to TRAB [50]. Li et al. also evaluated the effect of PT versus TRAB alone and concluded that the PT group had better outcomes when compared to TRAB. However, the sample size and the follow-up period were less in their study [51]. Contrary to this Lochhead et al. stated that TRAB was better with a significant difference in the IOP reduction and surgical success when compared to PT [52]. Chang et al. [53] compared the effect of PT with 5-FU to TRAB with 5-FU and found conflicting results wherein the surgical success rate was similar for both, with a greater mean IOP reduction in the latter. Choy BN asserted an equal IOP control with the TRAB group having more diffuse blebsand less incidence of failure [54]. Another study by Tan et al. gave contrasting results with a higher rate of complications in the TRAB group than in the PT group [55]. Lam and Wechsler found comparable IOP reduction in both eyes at 5 years with both procedures, though, the number of AGMs required postoperatively was higher in the PT group [56].

TRAB Versus Tube Surgery

Implants have revolutionized glaucoma surgery, especially in refractory cases [58-65]. A recent metanalysis comparing five systematic reviews on TRAB versus shunt surgeries concludedthat shunt surgeries might achieve greater qualified success than TRAB [58]. It is, however, not clear whether the aqueous shunts are superior to TRAB owing to the lack of sufficient evidence with regards to aspects like cost-effectiveness and long-term visual function preservation. Studies comparing TRAB versus tube surgeries and their outcomes are listed in Table 2. Another meta-analysis by HaiBo et al. comparing Ahmed glaucoma valve implant (AGV) to TRAB also reported no significant difference in IOP reduction between the two surgeries [59]. Similarly, Tseng et al. [60] conducted a Cochrane database systematic review on the safety and efficacy of aqueous shunts (both Ahmed and Baerveldt implants) in comparison with conventional TRAB and concluded there were not many differences between aqueous shunts and TRAB for glaucoma treatment. A systematic review by Hong et al. [61] on glaucoma drainage devices (GDDs, including Ahmed, Molteno, Baerveldt, Krupin) with a total of 52 studies and 2682 patients, concluded that GDD is more effective in refractory glaucoma. To summarize, TRAB with MMC seems to be equally effective as tube-shunt surgeries with preservation of long-term visual function being achievedby both surgeries, albeit with TRAB achieving it for a longer time [63].

TRAB Versus Laser Trabeculoplasty

Laser trabeculoplasty has been a well-established technique for lowering IOP in POAG and ocular hypertension patients over the last two decades [66-70]. Wise and Witter reported IOP reduction by 10 mm Hg in 40 patients with phakic eyes, using argon laser, with 65% of these eyes requiring AGMs to control IOP [66]. The Glaucoma Laser Trial Research Group compared argon laser trabeculoplasty (ALT) to antiglaucoma medicationand found better control in IOP with laser trabeculoplasty alone compared to a single AGM at 6 months, 1 year, and 2 years [67]. Studies evaluating selective laser trabeculoplasty (SLT) and glaucoma surgery are lacking in the literature. The EMGT (Early Manifest Glaucoma Trial) study observed that a 1 mmHg reduction in IOP from baseline decreased the risk of progression by 10% [68]. The advanced glaucoma intervention study (AGIS) looked at the effect of ALT before or after TRAB and found no change in white individuals. Neither prior ALT nor prior TRAB had a statistically significant effect on the failure of other procedures [69]. For 168 patients with uncontrolled chronic glaucoma, Migdal and Hitchings conducted a prospective clinical study comparing laser trabeculoplasty, medical therapy, and surgery as the primary therapy and concluded that the surgical group had the lowest average intraocular pressures and was the most successful at managing IOP diurnal swings [70]. Whilst laser trabeculoplasty resulted in a smaller reduction in pressure, these individuals were more likely to have high-pressure spikes.

TRAB In POAG

The role of TRAB in primary open-angle glaucoma patients (POAG) is well-established, however, there had been few anecdotal reports from few studies on its IOP reduction rates and visual field progression rates [71-75]. A recent study by Mataki et al. [71] in POAG documented a visual field (VF) progression of 0.7 decibels (dB)/year with a mean IOP of 15.7 mmHg. Similarly in a US-based study, Iverson et al. [72] reported a VF progression rate of 1.1 dB/year pre-operatively that had a mean IOP of 13.5 mmHg. Caprioli et al. [73] also confirmed in their study that TRAB can improve or maintain long-term visual function, a resultthat has not been proved unequivocally with other newer or older glaucoma surgeries.

TRAB In PACG

TRAB is the most common procedure used to reduce the IOP in both acute primary-angle closure glaucoma and chronic primary-angle closure glaucoma that are unresponsive to medical and laser treatment [76-77]. The overall success rate of TRAB varies from 68% to 100% depending upon the race and population [77]. However, because of the complications associated with TRAB, including cataract development, this is now less preferred.Adding to this is the high incidence of malignant glaucoma in this group of patients.

TRAB in Pseudoexfolaition Glaucoma

Pseduoexfoliative glaucoma (XFG) is known to be more aggressive than other types of glaucoma with a high rate of intraoperative complications like vitreous loss, zonular damage, clinically significant choroidal detachment, and choroidal hemorrhage [78-81]. Popovic and Sjostrand [80] compared the efficacy of TRAB in XFG eyes and POAG eyes and reported comparable results in both with a marginally better outcome in XFG eyes. Contrary to this, a recent study by Li et al. proclaimed significantly lower long-term success rates at 3 years and 5 years of follow-up in XFG eyes than in POAG eyes, though the short-term success rates were similar [81]. Ehrnrooth et al. [78] compared 55 POAG eyes with 83 XFG eyes and found a significantly higher overall success rate for patients with POAG than XFG and reported that a higher preoperativeIOP>30 mm Hg in the early postoperative period having an adverse effect on the surgical success of TRAB in XFG. Another study by Gurlu et al. [79] found no significant difference in the long-term success of TRAB between the two groups whose clinical characteristics are otherwise similar.

TRAB in Normal Tension Glaucoma (NTG)

Several landmark trials and studies have reported the efficacy of TRAB in NTG [82-87]. Naito et al. studied the effectiveness of TRAB in NTG patients with IOP<15 mmHg and found a significant reduction in mean IOP (8.1 2.9 mmHg) and the number of AGMs (0.8 1.5) [86]. In the Collaborative Normal-Tension Glaucoma Treatment Study (CNTGS) [83,84], nearly half of the eyes had undergone surgery, with an average post-operative IOP of 10.6 mmHg. The EMGT study [82], suggested that ALT may have a limited function in the treatment of NTG. A recent study that evaluated the effectiveness and long-term outcomes of TRAB using Moorfields technique claimed to have more successful long-term outcomes along with better safety and visual acuity preservation [87].

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Trabeculectomy: Does It Have a Future? - Cureus

FARMINGTON HILLS, Mich. - Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, announced the issuance of U.S. Patent No. 11,400,077. The patent provides added intellectual property protection for the company's late-stage product candidate, Nyxol (phentolamine mesylate), with claims directed to methods for treating mydriasis using phentolamine mesylate. The patent is eligible for listing in the U.S. FDA Orange Book and has a term extending into year 2039.

'We are very pleased with the issuance of this new patent for Nyxol, which extends our intellectual property protection in the U.S. by an additional five years into 2039,' said Mina Sooch, MBA, Founder and CEO of Ocuphire Pharma. 'Last year we were granted a new U.S. Patent for presbyopia extending our existing patent estate into year 2039 and now we are very pleased with the issuance of this new patent for Nyxol in reversal of mydriasis,' said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. 'As we own the worldwide rights to Nyxol for all indications, this added protection will position us to maximize the commercial value of Nyxol for at least 15 years in reversal of mydriasis as we plan to submit an NDA to the FDA later this year. If approved, Nyxol could be launched in the second half of 2023.'

Nyxol Eye Drops Patent Estate

Ocuphire owns all of the worldwide rights to Nyxol for all indications. Ocuphire's patent estate for Nyxol includes patents and patent applications for phentolamine mesylate formulations and methods of using phentolamine mesylate. Ocuphire's patent estate for Nyxol contains nine issued U.S. patents, eight pending U.S. non-provisional patent applications, as well as issued patents in Australia, Canada, Europe, Japan, and Mexico and pending patent applications in Australia, Canada, Europe, Japan, and other foreign countries. Ocuphire's first set of U.S. and foreign patents expire in year 2034, while Ocuphire's second set of U.S. patents expire in year 2039. Patents, if granted based on Ocuphire's pending foreign patent applications, would expire in year 2039.

Reversal of Mydriasis Market Opportunity

An estimated 100 million eye dilations are conducted every year in the U.S. to examine the back of the eye either for routine check-ups, disease monitoring or surgical procedures across all eye care practice groups. Depending on the individual and the color of their eyes, the pharmacologically-induced dilation can last anywhere from 6 to 24 hours in adults. Dilated eyes have heightened sensitivity to light and an inability to focus on near objects, causing difficulty reading, working and driving. Currently, there are no approved or available treatment options to safely reverse mydriasis. If approved, Nyxol has the potential to be the only FDA-approved drug for the reversal of mydriasis, uniquely modulating the pupil by blocking or 'relaxing' the ?1 receptors found only on the iris dilator muscle. This mechanism is differentiated from other miotics in that Nyxol moderately reduces the pupil size without engaging the ciliary muscle, resulting in favorable safety and tolerability seen across 12 completed trials in 3 indications by avoiding accommodative ciliary spasm, associated headaches and browaches, narrow angle closure, or risk of retinal detachment.

About Ocuphire Pharma

Ocuphire is a publicly-traded (NASDAQ: OCUP), clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of refractive and retinal eye disorders. The Company's lead product candidate, Nyxol eye drops?(0.75% phentolamine ophthalmic solution), is a once-daily, preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, and is being developed for several indications, including reversal of pharmacologically-induced mydriasis (RM), presbyopia and dim light or night vision disturbances (NVD), and has been studied in 12 completed clinical trials. Ocuphire has reported positive data from MIRA-2 and MIRA-3 registration trials and MIRA-4 pediatric safety trial for the treatment of RM. Ocuphire also reported positive topline data from the VEGA-1 Phase 2 trial of Nyxol for treatment of presbyopia, both Nyxol as a single agent and Nyxol with low dose pilocarpine ('LDP') 0.4% as adjunctive therapy. The Company recently reported positive topline results from LYNX-1 Phase 3 trial of Nyxol for NVD. Ocuphire's second product candidate, APX3330, is an oral tablet designed to inhibit angiogenesis and inflammation pathways relevant to retinal and choroidal vascular diseases, such as diabetic retinopathy (DR) and diabetic macular edema (DME) and has been studied in 11 Phase 1 and 2 trials. The Company announced in March the completion of enrollment in?the ZETA-1 Phase 2b clinical trial of APX3330 to treat DR/DME. Please visit?www.clinicaltrials.gov?to learn more about Ocuphire's ongoing APX3330 Phase 2b trial in DR/DME ZETA-1 (NCT04692688) and completed Nyxol trials: Phase 3 registration trial in NVD LYNX-1 (NCT04638660), Phase 3 registration trials in RM MIRA-2?(NCT04620213) and MIRA-3 (NCT05134974), MIRA-4 Phase 3 pediatric safety study (NCT05223478), and Phase 2 trial in presbyopia VEGA-1 (NCT04675151). As part of its strategy, Ocuphire will continue to explore opportunities to acquire additional ophthalmic assets and seek strategic partners for late-stage development, regulatory preparation, and commercialization of drugs in key global markets. For more information, visit?www.ocuphire.com.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, the success and timing of planned regulatory filings, the timing of planned commercialization of Nyxol in RM, the market for RM, business strategy, pre-commercialization activities, our ability to protect our intellectual property rights, and the potential for and success of commercialization of Ocuphire's product candidates, including Nyxol. These forward-looking statements are based upon Ocuphire's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) changes in capital resource requirements; (v) risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vi) legislative, regulatory, political and economic developments, (vii) changes in market opportunities, (viii) the effects of COVID-19 on clinical programs and business operations, (ix) the success and timing of commercialization of any of Ocuphire's product candidates and (x) the maintenance of Ocuphire's intellectual property rights. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and may be filed by Ocuphire from time to time with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact:

Corporate

Mina Sooch

President & CEO

Ocuphire Pharma, Inc.

E: ir@ocuphire.com

WEB: http://www.ocuphire.com

Investors

Corey Davis, Ph.D.

LifeSci Advisors

E: cdavis@lifesciadvisors.com

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Ocuphire Extends U.S. Patent Protection for Late-Stage Drug Candidate Nyxol for Reversal of Mydriasis by Five More Years into 2039 with New Patent...

1Manchester Royal Eye Hospital, Manchester, UK; 2Centre for Ophthalmology and Vision Sciences, Faculty of Medical and Human Sciences, University of Manchester, Manchester, UK

Correspondence: Andrew Walkden, Manchester Royal Eye Hospital, Oxford Road, Manchester, Greater Manchester, M13 9WL, UK, Tel +44 161-276-1234, Email [emailprotected]

Purpose: The COVID-19 pandemic has led to drastic changes to the daily lives of those living in the United Kingdom. We hypothesized that the effect of the imposed lockdown on both behaviour and social interaction has the potential to influence the characteristics of microbial keratitis presenting locally to Manchester Royal Eye Hospital a major tertiary eye centre in the UK.Methods: We conducted a retrospective case-note review of all positive corneal scrape cultures identified by our local microbiology laboratory during the year since the announcement of lockdown measures in the UK (23 March 2020 to 23 March 2021). Culture results were compared with previously collated, published baseline data from prior to the onset of the COVID-19 pandemic (2004 2019). Statistical analysis was undertaken, predominantly looking at the incidence of microbial keratitis and the variety of cultured pathogens.Results: A total of 6243 corneal scrape results were reviewed. Comparison of data between the COVID-19 pandemic and subsequent lockdown did not show a significant change in the incidence of culture-positive microbial keratitis: mean annual positive samples during 2004 2019 were 128 (35%) vs 91 (29%) during lockdown (P=0.096). No statistically significant shifts in the incidence of organism subtypes fungi, acanthamoeba, Gram-positive bacteria, or Gram negative bacteria were identified (P=0.196, 1, 0.366, and 0.087, respectively).Conclusion: Contrary to our hypothesis, our results suggest that the COVID-19 pandemic did not alter the incidence or characteristics of microbial keratitis presenting to Manchester Royal Eye Hospital in the year following the implementation of lockdown measures in the UK.

Microbial keratitis is a condition encountered across the world that can lead to irreversible sight loss.1 The incidence of the condition and causative microbes have been shown to have geographic and seasonal variation as a result of differing risk factors across regions.2,3 Previously identified risk factors include socioeconomic status, contact lens wear and hygiene practices, trauma, recent surgery, and a compromised ocular surface.4,5 Environmental factors, such as humidity, climate, and pathogenic environments, have also been shown to play a role.69

As the COVID-19 pandemic evolves and with the near-global enforcement of measures to curb the spread of the SARS-COV-2 virus, the behaviours and activities of the general population have drastically changed. Lockdown measures and social distancing were introduced in the UK on 23 March 2020 with the aim of reducing contact between humans and to limit transmission of the virus. This strategy is widely accepted by multiple international bodies to be the most effective strategy in limiting virus transmission.10

One of the most significant measures in place to deter the spread of this airborne virus is the use of face masks to limit and capture the spread of infective respiratory droplets. In the earlier stages of the pandemic, it was hypothesized that face masks may redirect expiratory airflow upwards towards the eyes, resulting in dispersion of oral flora onto the ocular surface and increasing the risk of post-intravitreal injection endophthalmitis. Patel et al recently published a large multicentre retrospective study of 505,968 intravitreal injections performed in the US that did not suggest that patient face-mask use influenced the rate of presumed acute-onset bacterial endophthalmitis (OR 0.74, 95% CI 0.511.19; P=0.097), but in fact reduced the rate of culture-positive endophthalmitis (OR 0.46, 95% CI 0.220.99; P=0.041).11 As the incidence of oral florarelated endophthalmitis is overall an extremely rare event, despite this studys large sample, the authors concluded that the study was underpowered and unable to demonstrate an effect of patient mask use on the incidence of oral floraassociated endophthalmitis.11 Consequently, an association between mask use and oral florarelated endophthalmitis and other ocular infections, such as microbial keratitis, remains unestablished.

Beyond mask use, we also hypothesized that other behavioural factors related to the pandemic may have played a role in affecting patients ocular surfaces and their exposure to pathogens. These included: infection-prevention measures, social distancing, social isolation, handwashing, disinfection protocols, widespread use of alcohol hand gels, change in lifestyle, indoor living, less traffic-related pollution, less contact lens wear at home, and increased screen time whilst working from home. The aim of this study was to assess what impact the COVID-19 pandemic has had on the incidence and characteristics of microbial keratitis presenting to Manchester Royal Eye hospital a major tertiary eye hospital in the UK.

Using the NHS Health Research Authority decision tool for ethics approval, this study was deemed not to require any ethics approval, as it employed anonymous unidentifiable retrospective patient data that was not generalisable and the study protocol did not involve any deviation from the expected standard of patient care.

Data were collected in the form of all corneal scrape specimens sampled in the year from the UK commencing its first national lockdown (23 March 2020). This period will be referred to as lockdown in the remainder of the text. Data were retrieved using our microbiology laboratorys established electronic database, and included date of the scrape with culture results and antimicrobial sensitivities. Equivalent data for 20042019 were also retrieved to use as our comparison control. Scrape data were categorised according to organism subtypes: fungi, acanthamoeba, and Gram-positive and Gram-negative bacteria.

Statistical analysis was performed using SPSS 25.0 and 2, two-sample t, and MannWhitney U tests between pre-COVID and post-COVID groups where applicable. P0.05 was considered statistically significant.

The methodology for corneal scrape specimen sampling was standardised as per departmental policy. This policy, as well as the microbiological methods utilised for organism identification and antibiotic-sensitivity testing at Manchester Royal Eye hospital, was described by Tan et al in 2017.12

A total of 6243 scrape results were included in this study. During the lockdown period, 312 scrapes were sent for analysis, with 91 (29%) producing a positive culture result. This is comparable with pre-lockdown figures of an average of 364 scrapes per annum with a culture-positive result of 128 (35%, P=0.096 using 2 testing (Table 1). We did note that there was a suggestion that the rate of positive scrape results was reduced, perhaps alluding to a decreased infection rate overall; however, these results did not achieve statistical significance. As such, the null hypothesis remains true, i.e., the incidence of microbial keratitis was not significantly influenced by the COVID-19 pandemic or measures implemented during the lockdown period. Table 2 shows the raw-data trends of scrape organisms grown from 2004 to the lockdown period. Table 3 compares the mean number of organism subtypes prior to lockdown and also during the lockdown period.

Table 1 Cross-tabulation of scrape positivity for pre-lockdown vs lockdown

Table 2 Data trends of scrape organisms 20042019 and for lockdown (2020)

Table 3 Mean number of keratitis subtypes prior to lockdown with number of cases during lockdown

The aim of this study was to assess the effect of the COVID-19 pandemic and the resultant national lockdown on the incidence and microbiological characteristics of microbial keratitis presenting to a major tertiary eye hospital in Manchester in the UK. Research in the early stages of the pandemic focused on identifying the systemic implications of a new virus. Whilst the literature suggests that dry eyes, conjunctivitis, keratitis and vein/cavernous sinus thrombosis, and other ocular pathology may be associated with COVID-19 infection, overall ocular morbidity from this viral infection is accepted to be minimal.1319

With the awareness of changing antimicrobial trends and contact lens usage, the authors have previously discussed the importance of understanding local pathogenic variations, with other units also examining their own data.3,12,2025 Large-scale societal and behavioural changes, such as social distancing and mask wearing, have the potential to have profound effects on certain diseases and can aid our understanding of disease pathogenesis. Our knowledge of the SARS-COV-2 virus is increasing as we see and treat more cases of the disease. However, the longer-term effects of the virus are likely to be more subtle, both in terms of any future morbidity from the disease itself but also the implications of trying to manage future waves of the pandemic, with long-term mask usage likely to continue for the foreseeable future.

With the widespread introduction of infection-prevention protocols and the enforced usage of personal protective equipment, reports regarding the increased incidence of dry-eye symptoms started to emerge from the literature.13,2629 It has been postulated that personal protective equipment and mask use may lead to a compromised tear film as a result of increased evaporation or even mechanical processes that lead to malposition of the eyelids, e.g., mask tape leading to ectropion, in addition to altered airflow surrounding the periocular area.26,29 A compromised tear film is known to result in reduced precorneal tear-film corneal coverage and epithelial microbreaks, which can increase the risk of ocular infections due to a reduction in the innate host ability of pathogen clearance when in contact with the ocular surface.26,30 Exacerbations in dermatological conditions in health-care workers and the general population have also been reported.31 Rosacea and other facial manifestations of dermatological disease are known to influence the ocular surface.32 The above theories led us to our hypothesis that COVID-19 or associated change in behaviours in our local population may have influenced the local incidence and characteristics of microbial keratitis.

Tan et al conducted a 12-year analysis of microbial keratitis presenting to Manchester Royal Eye Hospital.12 To the authors knowledge, this is the largest study of microbial keratitis trends in the UK to date.2225 Using an expanded dataset, we did not find any particular deviation from the baseline incidence of organisms when compared with those encountered during the lockdown period. We do however note that there are potential flaws with our statistical methodology, although conclusions may still be drawn from the results. This is in part due to the necessity to compare an average of 16 years worth of data with that of only 1 year of lockdown data. As this was a real-world study, examining a real world pandemic scenario, this is impossible to avoid. It is thus important to continue to examine the microbial trends, as continued mask wearing and social distancing may well play an evolving role into the future. As such, when comparing the statistical means from the pre-lockdown data to the results of the lockdown period, one does note that the values for the lockdown dataset are lower in numbers for all cases, particularly notable for the fungal keratitis subset. This may thus be unmasking an inherent and unavoidable type 2 error, which could only be corrected were the pandemic to continue in its current form for several years longer which, hopefully for everyone involved, will not happen.

Another limitation of this study was the inability to directly identify any causative factors that may influence the incidence and characteristics of microbial keratitis. One accepted limitation of our large sample is the lack of patient demographic data. The primary aim of this paper was to look at the causative pathogens of the microbial infections, rather than specific patient demographics. This has been done in detail for specific pathogens in other publications.21 Further to this, we note that the COVID-19 status of patients producing positive culture results was not assessed. Given the COVID-19 protocols at our hospital, only patients admitted for severe keratitis received a COVID-19 PCR test. We encouraged as many patients as possible to be treated on an outpatient basis, resulting in these patients not having their COVID-19 status assessed. These data are thus unobtainable. Whilst all our inpatients were screened as negative for COVID-19 (n=13), the selection bias of screening out milder presentations of keratitis does not allow for any further reliable and generalizable conclusions. Multiple factors may influence the annual incidence of microbial keratitis, and thus we opted to use a 16-year (as far as our electronic microbiological records extend) control period to allow for any expected annual confounding factors that may have influenced trends in keratitis rates.12

Lockdown measures in the UK were linked with a marked decrease in emergency department presentations.33 This effect was also identified in our own eye emergency department.34 This raised the concern that patients requiring urgent treatment for ocular conditions, such as microbial keratitis, may not seek appropriate urgent care.35 Sight-threatening conditions, such as retinal detachment, were found to be reduced compared to pre-lockdown figures.34 We are somewhat reassured that there was no significant fluctuation in the number of corneal scrape samples, suggesting that the number of presentations of microbial keratitis has not reduced dramatically, although the painful nature of the condition is likely to play a part in ensuring patients present to ophthalmic services, which may well be the determining factor for why patients present to the emergency department ahead of other painless forms of sight loss. A non-significant decrease in the incidence of samples for microbial keratitis may suggest that patients with milder infections have been able to access and receive treatment by other health-care providers specifically set up as part of the NHS response to the pandemic.36 Another potentially confounding factor may be that measures introduced in order to reduce patientdoctor contact time may have resulted in some less severe cases not receiving microbiological sampling. However, despite this, the standard protocol within our unit is to sample any ulcer with an associated infiltrate >1 mm in size. This may have inherently screened out more mild cases that were not sampled.

With all of the aforementioned being considered, our dataset would suggest that the use of widespread infection-prevention measures have not had a negative impact on our local populations corneal health. Whilst the results are not generalizable, these findings could be used to inform infection-control measures and protocols for patients with microbial keratitis presenting to similar tertiary ophthalmic services in the UK. Our local arrangements for the delivery of emergency eye care for microbial keratitis, infection-prevention practices, and encouraging changes in behaviour of our local population do not appear to have significantly affected the incidence or characteristics of microbial keratitis. We would encourage other units to assess their local incidence and characteristics of microbial keratitis so that the full impact of infection-prevention protocols on ocular health can be ascertained.

In conclusion, this retrospective study reviewed and compared all corneal scrapes undertaken at Manchester Royal Eye Hospital between 2004 and until 1 year following the enforcement of lockdown measures in the UK. We analysed the rates of culture-positive cases of infectious keratitis and characterised infections into subgroups. Overall, no statistically significant differences were identified in the incidence of microbial keratitis or the rates of causative pathogens. We did note that there was perhaps a small trend towards a reduced incidence of cases, in particular in the fungal subgroup. However, given data limitations and multiple confounding variables, the significance of this is uncertain. It is our hope that these findings may be useful in informing ophthalmic health-care providers assessing and treating patients with microbial keratitis in their own local populations and that it adds to an emerging body of evidence as we continue to recover from the COVID-19 pandemic.

No funding was received for this work from any sources.

None of the authors has any competing interests or affiliations.

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4. Green M, Apel A, Stapleton F. Risk factors and causative organisms in microbial keratitis. Cornea. 2008;27(1):2227. doi:10.1097/ICO.0b013e318156caf2

5. Keay L, Edwards K, Naduvilath T, et al. Microbial keratitis predisposing factors and morbidity. Ophthalmology. 2006;113(1):109116. doi:10.1016/j.ophtha.2005.08.013

6. Houang E, Lam D, Fan D, Seal D. Microbial keratitis in Hong Kong: relationship to climate, environment and contact-lens disinfection. Trans R Soc Trop Med Hyg. 2001;95(4):361367. doi:10.1016/S0035-9203(01)90180-4

7. Green M, Apel A, Stapleton F. A longitudinal study of trends in keratitis in Australia. Cornea. 2008;27(1):3339. doi:10.1097/ICO.0b013e318156cb1f

8. Ni N, Nam EM, Hammersmith KM, et al. Seasonal, geographic, and antimicrobial resistance patterns in microbial keratitis: 4-year experience in eastern Pennsylvania. Cornea. 2015;34(3):296302. doi:10.1097/ICO.0000000000000352

9. Lin CC, Lalitha P, Srinivasan M, et al. Seasonal trends of microbial keratitis in south India. Cornea. 2012;31(10):11231127. doi:10.1097/ICO.0b013e31825694d3

10. HM Government. Social distancing review: report. HM Government; 2021.

11. Patel SN, Tang PH, Storey PP, et al. The influence of universal face mask use on endophthalmitis risk after intravitreal anti-VEGF injections during the COVID-19 pandemic. Ophthalmology. 2021;18:45.

12. Tan SZ, Walkden A, Au L, et al. Twelve-year analysis of microbial keratitis trends at a UK tertiary hospital. Eye. 2017;31(8):12291236. doi:10.1038/eye.2017.55

13. Chen L, Deng C, Chen X, et al. Ocular manifestations and clinical characteristics of 535 cases of COVID-19 in Wuhan, China: a cross-sectional study. Acta Ophthalmol. 2020;98(8):e951e959. doi:10.1111/aos.14472

14. Nasiri N, Sharifi H, Bazrafshan A, Noori A, Karamouzian M, Sharifi A. Ocular manifestations of COVID-19: a systematic review and meta-analysis. J Ophthalmic Vis Res. 2021;16(1):103112. doi:10.18502/jovr.v16i1.8256

15. Siedlecki J, Brantl V, Schworm B, et al. COVID-19: ophthalmological aspects of the SARS-CoV 2 global pandemic. Klin Monbl Augenheilkd. 2020;237(5):675680. doi:10.1055/a-1164-9381

16. Bertoli F, Veritti D, Danese C, et al. Ocular findings in COVID-19 patients: a review of direct manifestations and indirect effects on the eye. J Ophthalmol. 2020;2020:e4827304. doi:10.1155/2020/4827304

17. Douglas KAA, Douglas VP, Moschos MM. Ocular manifestations of COVID-19 (SARS-CoV-2): a critical review of current literature. In Vivo (Brooklyn). 2020;34(3 Suppl):16191628. doi:10.21873/invivo.11952

18. Sen M, Honavar SG, Sharma N, Sachdev MS. COVID-19 and eye: a review of ophthalmic manifestations of COVID-19. Indian J Ophthalmol. 2021;69(3):488509. doi:10.4103/ijo.IJO_297_21

19. Hu K, Patel J, Swiston C, Patel BC. Ophthalmic Manifestations of Coronavirus (COVID-19). StatPearls Treasure Island (FL): StatPearls Publishing; 2021.

20. Griffin B, Walkden A, Okonkwo A, Au L, Brahma A, Carley F. Microbial keratitis in corneal transplants: a 12-year analysis. Clin Ophthalmol. 2020;14:35913597. doi:10.2147/OPTH.S275067

21. Zafar H, Tan SZ, Walkden A, et al. Clinical characteristics and outcomes of moraxella keratitis. Cornea. 2018;37(12):15511554. doi:10.1097/ICO.0000000000001749

22. Ting DSJ, Settle C, Morgan SJ, Baylis O, Ghosh S. A 10-year analysis of microbiological profiles of microbial keratitis: the North East England Study. Eye. 2018;32(8):14161417. doi:10.1038/s41433-018-0085-4

23. Tavassoli S, Nayar G, Darcy K, et al. An 11-year analysis of microbial keratitis in the South West of England using brain-heart infusion broth. Eye. 2019;33(10):16191625. doi:10.1038/s41433-019-0463-6

24. Orlans HO, Hornby SJ, Bowler IC. In vitro antibiotic susceptibility patterns of bacterial keratitis isolates in Oxford, UK: a 10-year review. Eye. 2011;25(4):489493. doi:10.1038/eye.2010.231

25. Henry CR, Flynn HW, Miller D, Forster RK, Alfonso EC. Infectious Keratitis progressing to endophthalmitis: a 15-year study of microbiology, associated factors, and clinical outcomes. Ophthalmology. 2012;119(12):24432449. doi:10.1016/j.ophtha.2012.06.030

26. Moshirfar M, West WB, Marx DP. Face mask-associated ocular irritation and dryness. Ophthalmol Ther. 2020;9(3):397400. doi:10.1007/s40123-020-00282-6

27. Hong N, Yu W, Xia J, Shen Y, Yap M, Han W. Evaluation of ocular symptoms and tropism of SARSCoV2 in patients confirmed with COVID19. Acta ophthalmologica. 2020;98(5):e649e655.

28. Wu P, Duan F, Luo C, et al. Characteristics of ocular findings of patients with coronavirus disease 2019 (COVID-19) in Hubei Province, China. JAMA Ophthalmol. 2020;138(5):575578. doi:10.1001/jamaophthalmol.2020.1291

29. Chadwick O, Lockington D. Addressing post-operative Mask-Associated Dry Eye (MADE). Eye. 2020;35(6):15431544. doi:10.1038/s41433-020-01280-5

30. Bhargava R. Contact lens use at the time of SARS-CoV-2 pandemic for healthcare workers. Indian J Med Res. 2020;151(5):392394. doi:10.4103/ijmr.IJMR_1492_20

31. Damiani G, Gironi LC, Grada A, et al. COVID-19 related masks increase severity of both acne (maskne) and rosacea (mask rosacea): multi-center, real-life, telemedical, and observational prospective study. Dermatol Ther. 2021;34(2):e14848. doi:10.1111/dth.14848

32. Stone DU, Chodosh J. Ocular rosacea: an update on pathogenesis and therapy. Curr Opin Ophthalmol. 2004;15(6):499502. doi:10.1097/01.icu.0000143683.14738.76

33. Thornton J. Covid-19: a&E visits in England fall by 25% in week after lockdown. BMJ. 2020;369:m1401. doi:10.1136/bmj.m1401

34. Young JF, Harron KL, Bilal L, Richardson JAL, Dhawahir-Scala FE. The effect of lockdown due to COVID-19 on a large emergency eye department: the manchester experience. J Clin Exp Ophthalmol. 2020;11(6):43.

35. Power B, Donnelly A, Murphy C, Fulcher T, Power W. Presentation of infectious keratitis to ED during COVID-19 lockdown. J Ophthalmol. 2021;2021:14. doi:10.1155/2021/5514055

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Impact of the COVID-19 Pandemic on the Incidence and Characteristics o | OPTH - Dove Medical Press

Participants will be introduced to the identification, degradation, and preservation of common photographic print materials, including the salted paper, albumen, silver gelatin, and chromogenic color processes. Ethical and other factors to consider in the preventative care of at-risk print materials will be outlined. We will address early direct positive processes the daguerreotype, ambrotype and tintype briefly. Well also discuss details pertaining to the manufacture, identification and preservation of gelatin dry plate and film-base negatives, along with basic considerations in the care of photographic albums. Well review preservation challenges related to large and diverse photographic collections with attention paid to the importance of proper environments and storage materials, emergency planning, and risk analysis. The value and significance of photography, global initiatives, and the pressing need to secure external funding and support through effective preservation advocacy will be emphasized throughout the webinar. Participants will receive a small selection of historic prints, to be returned at the conclusion of the webinar, for in-depth study. A listing of key publications and online resources will be provided. While each session will start with a webinar presentation, but we will include time for discussions with questions welcomed during or following each session using Zoom meeting.

The statements and opinions expressed by panelists, hosts, attendees, or other participants of this event are their own and do not necessarily reflect the opinions of, nor are endorsed by, the American Alliance of Museums.

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C2C Care Course The Preservation of Our Global Photographic Heritage: Here, There and Everywhere - aam-us.org

The American Psychological Association (APA) defines loneliness as the affective and cognitive discomfort or uneasiness from being or perceiving oneself to be alone or otherwise solitary.

In other words, loneliness is the mental or emotional discomfort you may experience from either being alone or feeling as though you are alone. This feeling stems from your social needs not being met and/or an inability to get the social connection you desire.

Although loneliness and being alone are commonly confused, being alone doesnt necessarily mean someone is lonely. Loneliness is a feeling, while being alone is a situation or state of being, which is not inherently negative, says Nina Vasan, M.D., psychiatrist and professor at Stanford University School of Medicine and chief medical officer at Real, an online mental wellness membership site.

You can feel lonely even when youre surrounded by other peoplesuch as a partner, family, co-workers or friends, continues Dr. Vasan.

Its also possible to be alone, but not feel lonely, she adds. For example, if youre by yourself but connecting to others through good communication or activities like volunteering, you dont feel lonely.

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Loneliness: Causes, Effects And Prevention Forbes Health - Forbes

Emily Moorhead is the chief operating officer of the central market at Detroit-based Henry Ford Health System.

Ms. Moorhead will serve on the panel "Building a Resilient, High-Reliability Organization With Accountable Leaders" at Becker's 10th Annual CEO + CFO Roundtable. As part of an ongoing series, Becker's is talking to healthcare leaders who plan to speak at the conference on Nov. 7-10 in Chicago.

To learn more and register, click here.

Becker's Healthcare aims to foster peer-to-peer conversation between healthcare's brightest leaders and thinkers. In that vein, responses to our Speaker Series are published straight from interviewees. Here is what our speakers had to say.

Question: What is the smartest thing you've done in the last year to set your system up for success?

Emily Moorhead: The smartest thing I could've done was foster a culture of belonging and supporting leaders so they can best front-line support staff. After two or more years of living through COVID-19, the great resignation, staffing crises, supply shortages, and now high inflation rates, the financial challenges and staff burnout are prevalent throughout all departments in the care continuum. Leaders must pause, breathe and ensure that we care for one another. Strengthening our culture to create a strong foundation will be vital to preparing for a large amount of change that will be required to be successful in the future.

Q: What are you most excited about right now and what makes you nervous?

EM: Value-based care is exciting. We've talked about the evolution from fee-for-service to value-based care for over a decade. Moving the industry away from sick care and focusing on prevention gets me out of bed in the morning!

Q: How are you thinking about growth and investments for the next year or two?

EM: Growth is about meeting the broader community's needs, which means expanding virtual care platforms to areas not easily served in the past. Having a data-driven approach to anticipate upcoming provider shortages to be proactive about unmet care needs and how we can help fill the voids through provider access and create more streamlined care models. Investments in technology make it easier for people to access the care they need. We must reduce the friction patients experience when seeking care.

Prevention and wellness is the new model we as healthcare leaders need to evolve that thinking to be true healthcare partners to the communities we serve. We need to align care with the patient's preferences to make getting the preventative care they need easier. Examples include virtual visits with a specialist in the ED, during the primary care visit before leaving, or same-day appointments.

Q: What will healthcare executives need to be effective leaders for the next five years?

EM: I think leading through a large amount of change and evolution needed in our industry will be leaders' primary focus for the next several years. This will require some tough decisions but can be done in a way that fosters integrity, respect and kindness. At its core, leadership is about caring for everyone in our sphere of influence. That means making sure they feel safe, valued, and purposeful. Leaders should strive for authenticity over perfection. Future health care leaders need to be more "heart grounded." Would our processes be the same if we were leading with our hearts? I'd argue they wouldn't; they'd be centered a little more closely around our patients, peers, and families. I think Simon Sinek says it best, "Leadership is not about being in charge. Leadership is about taking care of those in your charge."

Q: How are you building resilient and diverse teams?

EM: As it relates to diversity, we have an enterprise-wide DEIJ strategy that leads to the local committee work, including action plans related to intentional recruitment, unconscious bias training for all staff, governance members and providers, educational partnerships, the establishment of a voice of the community work group, and strategic planning efforts to improve access for under-represented communities.

Diversity makes us smarter, more innovative, and less married to the status quo. Diversity also offers the opportunity to see with new eyes. Diversity is broader than gender and race; we must tap into diverse experiences and cultures. The more varied the experiences around the table, the better the chance of change being successful and sustainable!

In terms of resiliency: fostering a culture of belonging, caring for one another and regular leadership check-ins. People stay in supportive, fun and collaborative environments, so fostering a strong culture is the foundation of a resilient team. But we must also be accountable for knowing when we are approaching burnout and need to unplug, rejuvenate and seek help.

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Prevention and wellness is the new model, a leader from Henry Ford Health System says - Becker's Hospital Review

With more employees resuming pre-pandemic lives, employers have an opportunity to offer routine health and wellbeing services.

During the pandemic, employers focused on Covid mitigation, social distancing and remote work, shares Susan Kirks, RN BSN COHN, manager of Employee Health and Wellness. With more employees back in person, we have a great opportunity to help people get back on track, especially when it comes to preventative and routine healthcare.

According to the CDC, more than four in 10 U.S. adults avoided getting necessary medical care during the height of the pandemic. While many Americans are ready to resume routine medical visits, rising costs and inflation have them thinking twice.

With many employees looking for work flexibility and support, resuming or offering new occupational health services can be a win-win opportunity for employers offering:

Convenient onsite services: With Cone Health onsite providers, employers can offer initial baseline physicals and one-on-ones to help employees choose a primary care provider. According to the governments Office of Disease Prevention and Health Promotion, having access to primary careis associated with positivehealthoutcomes. Primary care providers support preventative care, early diagnosis and treatment of disease and chronic disease management.

Screenings and vaccinations: Employers hosting mobile screening[HS1], flus shot clinics, or biometric screenings for cholesterol, glucose, blood pressure and BMI send a strong message that they care about employee health and wellbeing.

Listen and learn presentations: With Cone Healths new virtual sessions, employees can log in from work, home or on-the-go to join to hear from experts on a range of topics, including nutrition, preventative health and exercise.

Onsite training: Make sure supervisors and staff are prepared with CPR or first aid training. Whether you want a refresher course or first-time training, our providers are ready to assist you with your workplace needs.

To learn more about occupational health offerings, contact Jacqueline Heyward at (336) 832-7315.

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Getting Back to Employer Health and Wellness Programs - Cone Health

Today, the White House and U.S. Department of Treasury are hosting a White House Summit on Building Lasting Eviction Prevention Reform. As funds for Emergency Rental Assistance (ERA) are beginning to wind down, the Summit will focus on the need for an all-out effort to build lasting reform including through the use of remaining American Rescue Plan (ARP) funds from ERA and State and Local Fiscal Recovery Fund (SLFRF) assistance. Having created a first-ever national infrastructure for eviction prevention, now is the time to ensure we build on this progress and prevent a return to an eviction system that allowed 3.6 million eviction filings a year, often for small amounts of funds and without any legal representation or eviction diversion options. The Summit will feature top Administration officials, Chairman of the Senate Banking, Housing, and Urban Affairs Committee Sherrod Brown, Eviction Lab Founder Matthew Desmond, and will include State Supreme Court Justices and national, state, and local leaders who have pioneered lasting reform approaches that can serve as national models (see Appendix).

The Biden-Harris Administration is also highlighting the most current data on the impact of the Emergency Rental Assistance available as of this moment.

The White House Summit Will Highlight Overall Progress of the Emergency Rental Assistance Program and Top Models of Reform at the State and Local Court and Government Levels.

The Summit will feature overall policy views from top Administration Officials, Matthew Desmond, President and CEO of the National Low Income Housing Coalition Diane Yentel, and Chairman of the Senate Banking Committee Sherrod Brown, as well as models of visionary court-led reform, presented by Michigan Supreme Court Chief Justice Bridget Mary McCormack, New Mexico Supreme Court Chief Justice C. Shannon Bacon, and New Orleans First City Court Chief Judge Veronica Henry. The Summit will also highlight top eviction prevention innovations in Chicago, IL, presented by Mayor Lori Lightfoot; Philadelphia, PA, presented by Councilmember Helen Gym (At Large); Cleveland, OH; Colorado; and Oregon.

The program will begin at 12:30 pm ET and is scheduled to conclude at 2:30pm ET.

The Urgent Need for Eviction System Reform

Visionary Court-Led Eviction System Reform

Innovations in State and Local Eviction Prevention

Charge to Invest Remaining American Rescue Plan Funds in Housing Stability

Congressional Efforts to Secure Housing Stability and Eviction Prevention

The Path Forward on Eviction Protections and Closing Remarks

APPENDIX: Eight Models of Top State and Local Innovations that Build on the Emergency Rental Assistance Infrastructure to Sustain Eviction Reform

Visionary Court-Led Eviction System Reform

Michigan: Adopting Long-Term Court-Based Eviction Diversion to Prevent Avoidable Evictions

Michigan Supreme Court Chief Justice Bridget Mary McCormack issued one of the earliest standing orders during the pandemic to pause the eviction process once a rental assistance application has been submitted. Building on these best practices, the Michigan Supreme Court has proposed a new statewide order permanently adopting the stay of eviction action when a tenant applies for assistance. The proposed order requires a mandatory pre-trial convening to ensure tenants have access to rights and resources and prevents default judgments. It also prohibits five-day eviction orders, offers remote hearings for tenants with barriers to accessing courts, and attaches detailed information about assistance to every summons, among other best practices. The state also dedicated ERA housing stability funds to increase tenant access to legal counsel, with Detroit legislatively adopting right to counsel in 2022.

New Mexico: Leveraging American Rescue Plan Funding and Collaborating with Landlords and Tenants to Design Sustainable Eviction Diversion Programs

New Mexico Supreme Court Chief Justice C. Shannon Bacon created a task force of tenant and landlord groups, ERA program administrators, housing programs and state and local officials to design and launch one of the longest, most successful court-ordered eviction diversion programs in the country, including a mandatory extension of the lease term where landlords accept rental assistance. The eviction diversion program includes increased access to legal representation, mediation, and financial navigators to provide holistic services to tenants at risk of eviction. Due to the success of the program in reducing evictions, the state will continue to fund the eviction diversion program with state funds initially made possible with American Rescue Plan funds.

New Orleans: Implementing Eviction Diversion and Right to Counsel to Secure Court-Based Reform

Chief Judge Veronica Henry developed the First and Second City Courts award-winning Eviction Diversion Program, a partnership between the City of New Orleans, First and Second City Courts, Southeast Louisiana Legal Services, Louisiana Fair Housing Action Center (LFHAC), Jane Place Neighborhood Sustainability Initiative, and Parochial Offices of the Court. The program diverts eviction cases to on-site ERA administrators, Eviction Help Desks, the Right to Counsel Program, and other supportive services to prevent eviction and stabilize housing. New Orleans built on the diversion program by legislatively adopting the right to counsel for tenants facing eviction in 2022 and initially funding the intervention with $2 million in ERA funds.

State and Local Innovations in Eviction Prevention

Philadelphia, Pennsylvania: Mandating Pre-filing Eviction Diversion and Prohibiting Harmful Tenant Screening Practices

Philadelphia Councilmember Helen Gym (At Large) introduced thenations first city ordinancemandating pre-filing eviction diversion, which went into effect in August 2020. As a result, tenants at risk of eviction receive access to rental assistance and legal representation and tenants and landlords are required to participate in a free mediation session with the goal of resolution through an agreement. The diversion program has changed the culture to one where eviction litigation is a last resort. The city is committing long-term funding for rental assistance, a key component of diversion. In addition, Philadelphia adopted the Renters Access Act, which prohibits screening of tenants based on certain eviction filings and requireslandlords to tell tenants why they were rejected and provide an opportunity to correct errors.

Chicago, Illinois: Access to Legal Services for Tenants and Landlords and Early Eviction Resolution

In July 2022, Chicago dedicated $8 million in ERA housing stability funds to adopt a three-year Right to Counsel pilot. The city is collaborating with legal service providers Lawyers Committee for Better Housing, Legal Aid Chicago, and CARPLS to provide legal representation and increase housing stability. The program is expected to double the number of tenants who have access to attorneys, serving 2,000 to 3,000 tenants per year, and greatly reduce eviction orders. Chicago landlords and tenants have also benefited from the Cook County Early Resolution Program that diverts eviction cases to mediation and provides free legal aid to both tenants and unrepresented landlords. These programs have also effectively leveraged state law to seal pandemic-era eviction filing records for tenants, preventing the Scarlet E of eviction that results in a downward move and long-term hardship.

Cleveland, Ohio: Permanently Adopting Right to Counsel and Serving Tenants at Highest Risk of Eviction

The City of Clevelandwas among the first cities in the United States to legislatively adopt right to counsel, immediately prior to the onset of the COVID-19 pandemic, initially funding the program through a public-private partnership including the City of Cleveland, United Way and the Cleveland Foundation, among others. As private funds sunset, Cleveland has allocated Emergency Rental Assistance funds and is working to sustain right to counsel with long-term government support and additional American Rescue Plan funding, and amplifying its effectiveness through the development of an eviction diversion program that includes pre-filing mediation. To ensure services reach those with the greatest need, partners have combined data analysis with canvassing and door knocking. Zip code data on eviction rates and the lowest number of requests for assistance allows partners to identify and target outreach to the most marginalized, highest risk tenants.

Colorado: Partnering with Nonprofits to Provide Immediate Eviction Prevention and Rental Assistance

In Colorado, the COVID-19 Eviction Defense Project launched the Colorado Stability Fund, a unique revolving rental assistance fund capable of issuing quick, accurate ERA payments in less than 24 hours through a new partnership between the COVID-19 Eviction Defense Project (CEDP), Colorado Housing and Finance Authority (CHFA), and Colorados Division of Housing (DOH). The Stability Fund is available to all Colorado renters and gives those facing eviction a single point of contact for housing stability services and integrates intake and navigation, rapid rental aid payments, eviction legal defense, and, when necessary, rehousing support. The initiative is strengthened by partnerships with legal aid organizations and organizations by and for Black, Indigenous, people of color (BIPOC) communities to ensure resources reach those at greatest risk of displacement with deference to cultural context. In Denver, the program works seamlessly with the right to counsel, adopted in 2021. To ensure continued eviction prevention, partners are working to sustain the program long-term with funds from the state and are expanding to other housing areas, including foreclosure.

Oregon: Community Partnerships to Provide Rapid Eviction Prevention to the Highest Risk Tenants

Oregon was one of the first states to supplement ERA funds with SLFRF and state funding. In addition, the state developed and funds the Eviction Prevention Rapid Response Program, a partnership between the Oregon Law Center and the Oregon Housing and Community Services (OHCS) that serves as a critical element of the Eviction Defense Project. The program allows for rapid financial assistance to prevent eviction and homelessness, since legal aid can verify tenant eligibility and provide flexible funds to prevent evictions, including rental assistance, cleaning services, moving expenses, and more.OHCS also partners with community-based tenant organizations and nonprofits, including Unite Oregon, Bienestar, and the Springfield Eugene Tenants Association. During the height of the pandemic, these trusted community groups conduct outreach to community members at risk of eviction, including engaging in multi-lingualdoor knocking, and connecting their neighbors with resources to avoid eviction. As part of ongoing eviction prevention efforts, OHCS is also partnering with the Urban League of Portland, Immigrant and Refugee Organization (IRCO), and other community organizations statewide to conduct community outreach and provide critical eviction prevention services.

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FACT SHEET: White House Summit on Building Lasting Eviction Prevention Reform - The White House

Contemporary guidelines highly recommend patients with heart failure with reduced ejection fraction (HFrEF) be on all four drug classes that together have shown clinical clout, including improved survival, in major randomized trials.

Although many such patients don't receive all four drug classes, the more that are prescribed to those with primary prevention implantable defibrillators (ICD), the better their odds of survival, a new analysis suggests.

The cohort study of almost 5000 patients with HFrEF and such devices saw their all-cause mortality risk improve stepwise with each additional prescription they were given toward the full quadruple drug combo at the core of modern HFrEF guideline-directed medical therapy (GDMT). The four classes are SGLT2 inhibitors, betablockers, mineralocorticoid receptor antagonists (MRA), and renin-angiotensin system (RAS) inhibitors.

That inverse relation between risk and number of GDMT meds held whether patients had solo-ICD or defibrillating cardiac resynchronization therapy (CRT-D) implants; independently of device-implantation year and comorbidities; and regardless of HFrEF etiology.

"If anybody had doubts about really pushing forward as much of these guideline-directed medical therapies as the patient tolerates, these data confirm that by doing so, we definitely do better than with two medications or one medication," Samir Saba, MD, University of Pittsburgh Medical Center, Pennsylvania, told theheart.org| Medscape Cardiology.

The analysis begs an old and challenging question: Do primary prevention ICDs confer clinically important survival gains over those provided by increasingly life-preserving recommended HFrEF medical therapy?

Given the study's incremental survival bumps with each added GDMT med, "one ought to consider whether ICD therapy can still have an impact on overall survival in this population," proposes a report published online July27 in JACC Clinical Electrophysiology, with Saba as senior author and Mehak Dhande, MD, also from University of Pittsburgh Medical Center, as lead author.

In the adjusted analysis, the 2-year risk for death from any cause in HFrEF patients with primary prevention devices fell 36% in those with ICDs and 30% in those with CRT-D devices for each added prescribed GDMT drug, from none up to either three or four such agents (P< .001 in both cases).

Only so much can be made of nonrandomized study results, Saba observed in an interview. But they are enough to justify asking whether primary prevention ICDs are "still valuable" in HFrEF given today's GDMT. One interpretation of the study, the published report notes, is that contemporary GDMT improves HFrEF survival so much that it eclipses any such benefit from a primary prevention ICD.

Both defibrillators and the four core drug therapies boost survival in such cases, "so the fundamental question is, are they additive. Do we save more lives by having a defibrillator on top of the medications, or is it overlapping?" Saba asked. "We don't know the answer."

For now, at least, the findings could reassure clinicians as they consider whether to recommended a primary prevention ICD when there might be reasons not to, as long there is full GDMT on board, "especially what we today define as quadruple guideline-directed medical therapy."

Recently announced North American guidelines defining an HFrEF quadruple regimen prefer beyond a betablocker, MRA, and SGLT2 inhibitor that the selected RAS inhibitor be sacubitril/valsartan (Entresto, Novartis), with ACE inhibitors or angiotensin-receptor blockers (ARBs) as a substitute, if needed.

Nearly identical European guidelines on HFrEF quad therapy, unveiled last year, include but do not necessarily prefer sacubitril/valsartan over ACE inhibitors as the RAS inhibitor of choice.

Primary prevention defibrillators entered practice at a time when expected background GDMT consisted of betablockers and either ACE inhibitors or ARBs, the current report notes. In practice, many patients receive the devices without both drug classes optimally on board. Moreover, many who otherwise meet guidelines for such ICDs won't tolerate the kind of maximally tolerated GDMT used in the major primary prevention device trials.

Yet current guidelines give such devices a classI recommendation, based on the highest level of evidence, in HFrEF patients who remain symptomatic despite quad GDMT, observed GreggC. Fonarow, MD, University of California Los Angeles Medical Center.

The current analysis "further reinforces the importance of providing all four foundational GDMTs" to all eligible HFrEF patients without contraindications who can tolerate them, he told theheart.org| Medscape Cardiology. Such quad therapy, he said, "is associated with incremental 1-year survival advantages" in patients with primary prevention devices. And in the major trials, "there were reductions in sudden deaths, as well as progressive heart failure deaths."

But the current study also suggests that in practice, "very few patients can actually get to all four drugs on GDMT," said Roderick Tung, MD, University of Arizona College of Medicine, Phoenix. Optimized GDMT in randomized trials probably represents the best-case scenario, he told theheart.org| Medscape Cardiology. "There is a difference between randomized data and real-world data, which is why we need both."

And it asserts that "the more GDMT you're on, the better you do," he said. "But does that obviate the need for an ICD? I think that's not clear," in part because of potential confounding in the analysis. For example, patients who can take all four agents tend to be less sick than those who cannot.

"The ones who can get up to four are preselected, because they're healthier," Tung said. "There are real limitations such as metabolic disturbances, acute kidney injury and cardiorenal syndrome, and hypotension that actually make it difficult to initiate and titrate these medications."

Indeed, the major primary prevention ICD trials usually excluded the sickest patients with the most comorbidities, Saba observed, which raises issues about their relevance to clinical practice. But his group's study controlled for many potential confounders by adjusting for, among other things, Elixhauser comorbidity score, ejection fraction, type of cardiomyopathy, and year of device implantation.

"We tried to level the playing field that way, to see if despite all of this adjustment the incremental number of heart failure medicines stills make a difference," Saba said. "And our results suggest that yes, they still do."

The analysis of patients with HFrEF involved 3210 with ICD-only implants and 1762 with CRT-D devices for primary prevention at a major medical center from 2010 to 2021. Of the total, 5% had not been prescribed any of the four GDMT agents, 20% had been prescribed only one, 52% were prescribed two, and 23% were prescribed three or four. Only 113 patients had been prescribed SGLT2 inhibitors, which have only recently been indicated for HFrEF.

Adjusted hazard ratios for death from any cause at 2years for each added GDMT drug (P< .001 in each case), were:

0.64 (95%CI, 0.56- 0.74) for ICD recipients

0.70 (95%CI, 0.58- 0.86) for those with a CRT-D device

0.70 (95%CI, 0.60- 0.81) for those with ischemic cardiomyopathy

0.61 (95%CI, 0.51- 0.73) for patients with nonischemic disease

The results "raise questions rather than answers," Saba said. "At some point, someone will need to take patients who are optimized on their heart failure medications and then randomize them to defibrillator versus no defibrillator to see whether there is still an additive impact."

Current best evidence suggests that primary prevention ICDs in patients with guideline-based indications confer benefits that far outweigh any risks. But if the major primary prevention ICD trials were to be repeated in patients on contemporary quad-therapy GDMT, Tung said, "would the benefit of ICD be attenuated? I think most of us believe it likely would."

Still, he said, a background of modern GDMT could potentially "optimize" such trials by attenuating mortality from heart failure progression and thereby expanding the proportion of deaths that are arrhythmic, "which the defibrillator can prevent."

Saba discloses receiving research support from Boston Scientific and Abbott; and serving on advisory boards for Medtronic and Boston Scientific. The other authors report they have no relevant relationships. Tung has disclosed receiving speaker fees from Abbott and Boston Scientific. Fonarow has reported receiving personal fees from Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Edwards, Janssen, Medtronic, Merck, and Novartis.

JJ Am Coll Cardiol EP. Published online July27, 2022. Abstract

Follow Steve Stiles on Twitter: @SteveStiles2. For more from theheart.org, follow us on Twitter and Facebook.

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Do ICDs Still Work in Primary Prevention Given Today's HF Meds? - Medscape

The combustible combination of lightning, a record-setting heat wave, a weeks-long dry spell and gale-force winds on Sunday afternoon, July 31, contributed to Baker Countys biggest wildfire so far this year.

The Big Rattlesnake fire burned 425 acres in the remote Powder River Canyon between Thief Valley Reservoir and Highway 203, and for a few hours posed a threat to several homes.

The Baker County Sheriffs Office issued a Level 2 evacuation notice be prepared to leave at a moments notice for five or six homes on the west side of Highway 203 on Sunday evening, and a Level 1 notice be ready for the possible need to evacuate for residents east of the highway along Miles Bridge Road.

No one was evacuated, and no structures were damaged, said Jason Yencopal, the countys emergency manager. The evacuation notice was canceled for areas east of the highway on Monday morning, Aug. 1, and reduced to Level 1 for homes west of the highway, Sheriff Travis Ash said.

There are three levels of evacuation notice. Under Level 3, which was not initiated for the Big Rattlesnake fire, residents are told to leave immediately.

Ash said on Monday morning that the preliminary evacuation notices were given as a precaution mainly due to the strong winds that initially caused the fire, which was reported a little before 5 p.m., to grow rapidly.

When the wind calmed later Sunday evening, the fire activity also slowed, Ash said.

Jonathan Dunbar, fire duty officer for the Bureau of Land Managements Vale District, said the fire did not grow overnight Sunday into Monday.

Crews will continue to secure the perimeter and mop up today, Dunbar said in a press release Monday morning.

Rancher grateful for fast work by firefighters

Mike McGinnis smelled the smoke and watched the powerful gusts bending the grass near the ranch he and his wife, Nicky, own just west of Highway 203 between the Powder River and Medical Springs.

McGinnis feared that if the flames crossed the Big Creek canyon, which is between his home and where the fire started, those winds could quickly push the fire toward his house and outbuildings.

But later on Sunday evening the wind shifted direction, he said, blowing the flames back toward areas that had already burned.

McGinnis said the fire didnt get closer than about a mile to his home.

On Monday morning McGinnis said he was grateful for the amazing response by firefighters, many of them volunteers from local districts.

You just cannot say enough about these rural volunteer firefighters, McGinnis said. Theyre willing to put everything on the line. Were blessed with a great community. People truly care. Its a great feeling.

McGinnis said he was home when the storm that sparked the fire passed through.

Terrain blocks his view of the spot where the lightning bolt struck, but McGinnis said a neighbor, John Wirth, saw the lightning and phoned after seeing the smoke rising.

Wirth said he was driving on Blue Mountain Ridge Road, which follows a spine of high ground east of Highway 203, when he saw the thunderstorm approaching.

Wirth said when lightning threatens he usually tries to find an elevated vantage point to watch for downstrikes and the fires that are likely to start as a result. He said he has seen that happen several times.

On Sunday evening, Wirth said he could see flames within just a few seconds of the bolt hitting west of Big Creek.

Its just about immediate fire, he said. Theres a lot of fuel, and there was a lot of wind then.

On Monday morning, McGinnis said he was watching through binoculars as firefighters worked on the blaze, which seemed to be mainly out, although he did see some smoke.

Theyre doing a great job, he said.

Winds caused major concern

Although there are no weather stations close to the fire, the wind gauge at the Baker City Airport recorded a peak gust of 62 mph at 7:38 p.m. on Sunday.

Winds propelled a dust cloud from a fallow field just north of Baker City a little after 7 p.m.

Buzz Harper, chief of the Keating Rural Fire Protection District, estimated winds were gusting between 45 and 50 mph when he arrived Sunday evening.

Colby Thompson, chief of the North Powder Rural Fire Protection District, said the wind direction shifted four times while he was working on the fire Sunday evening.

Three single-engine aircraft dropped retardant ahead of the fire on Sunday evening, said Larisa Bogardus, public affairs officer for the Bureau of Land Managements Vale District.

Harper served as incident commander for areas along Highway 203, and he assigned fire trucks to protect the McGinnis ranch and several other homes west of the highway, which leads north through Pondosa and Medical Springs to Union.

The trucks were reassigned later on Sunday evening after the threat eased, Ash said.

Highway 203 was closed temporarily except for fire vehicles and local traffic.

Everybody did really well, Harper said on Monday morning. We had a lot of resources.

He credited the Sheriffs Office and Oregon State Police for helping notify residents about evacuation levels, and the Oregon Department of Transportation for coordinating the highway closure.

Harper said the Sheriffs Offices mobile communications trailer was also a benefit to the multiple agencies that responded.

Fuels have dried during recent rainless stretch

The fire started about half a mile north of the Powder River and about a mile west of Big Creek.

Both the river and the creek flow through deep, steep canyons.

The fire burned in dense thickets of sagebrush, with lighter fuels on ridgetops, Bogardus said.

Fuels have dried considerably during a lengthy rainless stretch that followed the damp, cool spring.

The Baker City Airport has recorded just 0.08 of an inch of rain scarcely enough to dampen the ground since June 4.

Phil Whitley, chief of the Medical Springs Rural Fire Protection District, said rain fell in the area Sunday evening, but amounts were generally meager.

The fire burned on both public and private land, Bogardus said.

The area includes sage grouse habitat, she said.

The fire is within the BLMs 5,880-acre Powder River Canyon Area of Critical Environmental Concern. The agency manages the public land to protect raptor and wildlife habitat and scenic qualities, according to a BLM press release.

On Monday morning, six fire engines were working on the fire and two 20-person crews were en route, Bogardus said.

Single-engine tankers and helicopters were available if needed, she said.

Whitley, who lives near Medical Springs, said he saw several lightning bolts before receiving a page on his radio about the fire.

Whitley said seven volunteers from the Medical Springs district assembled. They tried to reach the fire from a dirt road that leads west from Highway 203, but Whitley said the road, which descends into the Big Creek canyon, crosses the creek and continues west up the Powder River, was too rough to negotiate with a truck laden with water.

Whitley said crews from other agencies were able to get to the fire via that route later.

Thompson, chief of the North Powder Rural Fire Protection District, said volunteers from the department used a bulldozer to make the road passable to fire engines, including four from the North Powder district. A total of 17 volunteers from the district worked on the fire Sunday, Thompson said.

A major focus initially was to protect the McGinnis ranch, Whitley said.

Their home was closest to the fire, and the powerful winds, which were shifting direction frequently, made it difficult to predict where the fire was moving, Whitley said.

Other agencies that responded to the Big Rattlesnake fire include the Baker Rural Fire Protection District, Lookout-Glasgow Rangeland Fire Protection Association and Eagle Valley Rural Fire Protection District.

Other, smaller fires reported

Lightning from a series of thunderstorms that moved through the region Sunday afternoon and evening sparked at least two other, much smaller, blazes.

One burned a quarter of an acre about 2.5 miles north of Anthony Lakes.

The other burned less than a tenth of an acre near the Kelly Mine, about 2 miles north of Bourne.

The combination of hot temperatures a record high was set at the Baker City Airport on July 29, and the record tied on July 30 and lack of rain has resulted in rapidly rising fire danger.

The Energy Release Component, a measurement of how fast a fire would spread, had been below average for most of the summer for each of the six regions that the Blue Mountain Interagency Dispatch Center in La Grande monitors.

But over the last week of July that figure, which is updated daily, climbed above average in each region.

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Wind-fanned lightning fire prompted precautionary evacuation notices near Medical Springs Sunday evening - Baker City Herald

Aliria Rosa Piedrahita de Villegas should have developed Alzheimers disease in her 40s and died from the disease in her 60s because of a rare genetic mutation.

Instead, she lived dementia-free into her 70s, and now her brain is yielding important clues about the pathology of dementia and possible treatments for Alzheimers disease.

As researchers at Massachusetts General Hospital and other centers first described in 2019, the woman, from Medellin, Colombia, was a member of an extended family with a mutation in a gene labeled PSEN1. The PSEN1 E280A mutation is autosomal dominant, meaning that only a single copy of the gene is required to cause disease. Carriers of the mutation typically exhibit symptoms of Alzheimers in their 40s or 50s, and die from the disease soon after, but this woman did not begin to show signs of Alzheimers until her early 70s. She died in 2020 from metastatic melanoma at the age of 77.

The key difference in the Colombian womans ability to fend off the disease for three decades appeared to be that in addition to having the PSEN1 E280A mutation, she was also a carrier of both copies of a mutation known as APOE3 Christchurch.

This exceptional case is an experiment designed by nature that teaches us a way to prevent Alzheimers: lets observe, learn, and imitate nature.

Francisco Lopera, director of the Neuroscience Group of Antioquia in Medelln, Colombia.

The APOE family of genes control production of apolipoproteins, which transport lipids (fats) in blood and other bodily fluids.The APOE2 variant is known to be protective against Alzheimers dementia, while the APOE4 variant is linked to an increased risk for the disease.

APOE3, the most common variant, is not typically associated with either reduced or increased risk for Alzheimers.

This is a ground-breaking case for Alzheimers disease and has already opened new paths for treatment and prevention, which were currently pursuing with some collaborators. This work is now bringing light into some of the mechanisms of resistance to Alzheimers disease says investigator Yakeel T. Quiroz

Quiroz is director of theMulticultural Alzheimer Prevention Program (MAPP) at Mass General, an associate professor of psychology at Harvard Medical School, andPaul B. and Sandra M. Edgerley MGH Research Scholar 2020-2025.

As Quiroz and colleagues now report in the neuropathology journalActa Neuropathologica, the woman did, in fact, have pathologic features of Alzheimers disease in her brain, but not in regions of the brain where the hallmarks of Alzheimers are typically found.

This patient gave us a window into many competing forces abnormal protein accumulation, inflammation, lipid metabolism, homeostatic mechanisms that either promote or protect against disease progression, and begin to explain why some brain regions were spared while others were not, says Justin Sanchez, co-first author, and an investigator at MGH Neurology.

Researchers identified in Alirias brain a distinct pattern of abnormal aggregation or clumping of tau, a protein known to be altered in Alzheimers disease and other neurologic disorders.

In this case, the tau pathology largely spared the frontal cortex, which is important for judgment and other executive functions, and the hippocampus, which is important for memory and learning. Instead, the tau pathology involved the occipital cortex, the area of the brain at the back of the head that controls visual perception.

The occipital cortex was the only major brain region to exhibit typical Alzheimers features, such as chronic inflammation of protective brain cells called microglia, and reduced levels of APOE expression.

Thus, the Christchurch variant may impact the distribution of tau pathology, modulates age at onset, severity, progression, and clinical presentation of [autosomal dominant Alzheimers disease], suggesting possible therapeutic strategies, the researchers write.

It is seldom that we have nice surprises while studying familial Alzheimers disease brains. This case showed an amazingly clear protected phenotype. I am sure our molecular and pathologic findings will at least suggest some avenues of research and elicit hope for a successful treatment against this disorder. says co-first author Diego Sepulveda-Falla, research lead at University Medical Center Hamburg-Eppendorf in Hamburg, Germany.

This exceptional case is an experiment designed by nature that teaches us a way to prevent Alzheimers: lets observe, learn, and imitate nature, concludes Francisco Lopera, director of the Neuroscience Group of Antioquia in Medelln, Colombia. Lopera is a co-senior author and the neurologist who discovered this family and has been following them for the last 30 years.

Quiroz is a co-senior author of the report, along with Kenneth S. Kosik, University of California, Santa Barbara; Lopera, and Sepulveda-Falla. Sanchez contributed equally to the study.

The study was supported by grants from the National Institutes of Health, MGH Executive Committee on Research (MGH Research Scholar Award), Alzheimers Association, the Deutsche Forschungsgemeinschaft, Universidad de Antioquia, the Werner Otto Stiftung, and the Gernam Federal Ministiry of Education and Research.

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Alzheimer's-defying brain offers clues to treatment, prevention - Harvard Gazette

Health awareness

In this Teal Talks episode, TV host and cancer survivor Samantha Harris leads the conversation about the advances in cancer screenings and early prevention with three renowned cancer specialists

You may know Samantha Harris from hosting eight seasons of Dancing with the Stars and her many years on Entertainment Tonight, but shes also a cancer survivor or cancer thriver, as she prefers to be called.

At age 40, Harris was diagnosed with stage II invasive breast cancer and underwent a double mastectomy. Since her diagnosis, the Emmy-winning TV personality has become a fierce advocate for living a healthier life to help prevent chronic diseases like cancer.

We need to be our own best health advocates by knowing our body so we can recognize any changes and then find the right expert in the medical field to assess if there is or isnt something to worry about, said Harris, whos been in remission since October 2014.

In episode 5 of Teal Talks, Harris sits down with Dr. Laura Makaroff, SVP, prevention and early detection, American Cancer Society, and Mercks Dr. Scot Ebbinghaus, VP, late-stage oncology, and Steve Keefe, AVP, global clinical development, oncology, to discuss cancer prevention and advances in screening.

According to the American Cancer Society, about 18% of cancers in the U.S. are related to modifiable risk factors, and thus could be preventable.

Screening tests are another component of cancer prevention. Certain screenings aim to find cancer before it causes symptoms and when it may be easier to treat. There arent currently screening tests for every type of cancer, but there are several tests that health agencies recommend for breast, cervical, colorectal and lung cancers.

Cancer screening recommendations vary from country to country, so its important to talk to your doctor about which tests are right for you.

There are some people who fit a high-risk category because they have a family history of cancer or some other inherited condition and might need to start screening earlier or do a different kind of screening test than the average-risk population, said Makaroff. Its an important topic to bring up with your doctor and make sure that you, as a patient, know to ask the right questions.

[Source: American Cancer Society]

The COVID-19 pandemic caused a significant interruption to cancer screening services. In the U.S., it is estimated that 9.4 million cancer screenings were missed from January through July 2020 vs the same period in 2019.

Theres no one-size-fits-all type solution to get things back on track, said Keefe. But community outreach can help get peoples awareness about the importance of screenings back on track and help reassure people that when they return to the doctors office or clinic, precautions will be in place to help keep them safe from COVID-19.

Despite some of the dire statistics around cancer care disruptions, the health care industry gained some valuable lessons from the pandemic.

One of the things that the pandemic has taught us is that we can reach our patients even if they cant come into the doctors office, Ebbinghaus said. Being able to leverage telemedicine to counsel patients and arrange for testing could really help improve cancer preventative care.

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Experts discuss importance of cancer screenings and early detection - Merck

All samples will be referred through the Directorate of Public Health and Preventive Medicine and the Regional Integrated Disease Surveillance Programme network

All samples will be referred through the Directorate of Public Health and Preventive Medicine and the Regional Integrated Disease Surveillance Programme network

After being the first laboratory in Tamil Nadu to initiate COVID-19 testing and having tested about 31 lakh samples so far, the Department of Virology, King Institute of Preventive Medicine and Research (KIPMR), will now test samples for monkeypox.

Health Minister Ma. Subramanian, who inspected the facilities at the laboratory on Thursday, told reporters that clinical specimens collected from the skin, lesions, urine, serum/plasma would be tested for monkeypox at the 123-year-old KIPMR.

According to a release, the Indian Council of Medical Research (ICMR)/National Institute of Virology (NIV), Pune, trained the laboratory, along with 15 facilities in the country, to initiate monkeypox testing. All samples would be referred through the Directorate of Public Health and Preventive Medicine/the Regional Integrated Disease Surveillance Programme network to KIPMR and tested by real-time PCR. The sample should be accompanied with the clinical history.

There would be parallel testing at NIV, Pune, and the results would be released after confirmation by NIV, Pune, initially, the release said.

Monkeypox has been reported in 77 countries. In India, four cases have been reported so far and there has been no case in Tamil Nadu, he said.

Samples of two persons who had returned from Canada and the U.S. were sent for testing to NIV, Pune, after they developed lesions on the face last month. Both samples were negative for monkeypox. There has been no case of monkeypox in Tamil Nadu so far, he said.

He added that there was mass fever screening at the international airports. An advisory was issued to screen passengers travelling from the 77 countries or on transit. They were screened for symptoms, including for lesions, he said.

The Department of Virology of KIPMR is a World Health Organization (WHO)-National Polio Laboratory, a WHO reference laboratory for measles and rubella and an ICMR/DHR regional influenza referral laboratory as well. It also serves as the State-level Virus Research and Diagnostic Laboratory under ICMR/DHR, the release said.

Health Secretary P. Senthilkumar, Director of Medical Education R. Narayana Babu, Director of Public Health and Preventive Medicine T.S. Selvavinayagam and Director of KIPMR Kaveri were present.

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King Institute of Preventive Medicine and Research to test samples for monkeypox - The Hindu

Key populations provide valued contribution to development of new WHO guidelines

In 2020 the global key population networks including the International Network of People Who Use Drugs (INPUD), the Global Action for Trans Equality (GATE), the Network of Sex Worker Projects (NSWP) and the Global Action for Gay Mens Health Rights (MPACT) were commissioned by WHO to conduct values and preferences research within their communities in relation to HIV, viral hepatitis and STI services. This research has been used to inform the development of the new WHO Consolidated guidelines on HIV, viral hepatitis and STI prevention, diagnosis, treatment and care for key populations, launched on 29 July 2022 at AIDS2022 in Montreal, Canada.

To celebrate the launch of these important guidelines for improving the health and rights of the key populations in relation to HIV, viral hepatitis and STIs, INPUD reached out to several study participants from the community of people who use drugs and asked them to briefly reflect on why the key populations values and preferences research is important and what the new guidelines mean in the context of their lives. Here are extracts of their responses:

Why is it important to include the values and preferences of key populations living with and affected by HIV, viral hepatitis and STIs in the development of the WHO Key Populations Guidelines?

For people from marginalized and criminalized communities it often feels like no ones really listening to the knowledge we have to offer. Involving key populations in the development of the guidelines was critical to ensuring that lived and living experience was embedded within the guidelines not just being asked to make some comments after the guidelines are already developed. That happens way too often and it is tokenistic.

Involving the community is important for lots of reasons, including that peers are best placed to detect and identify stigma and discrimination. By making sure that the language of the guidelines is stigma-free and non-discriminatory, it establishes the standard we expect from health professionals using the guidelines and providing services. It is a practical way to show why our community must be at the heart of these kinds of processes.

Peers are clued into the real world settings of living with or being at risk of HIV, viral hep and STIs, where the clinical meets the real world. We will not achieve the elimination of HIV and viral hepatitis without the valuable perspective, insights, and expertise of peers.

Do WHO Key Population Guidelines such as these make a tangible difference in the lives of people living with and affected by HIV, viral hepatitis and STIs, including people who inject drugs?

As a trans person who injects drugs and is living with HIV, I feel empowered through the consultation process to inform the guidelines. I was able to contribute to the global response to HIV, viral hep, and STIs with something much bigger than myself and my work at the community level.

We are always talking about ways we can use policies and guidelines like these for our advocacy on behalf of people who use drugs. For example, we can use them to demand better services or human rights, but we can also use them to check against current guidelines, services and programmes and advocate for improvements.

Sometimes documents like these can seem far from our everyday lives as people who inject drugs, but if those providing harm reduction and other health services to people who inject drugs are aware of the guidelines and use them, it can really change the way we experience those services by removing some of the barriers.

The 2016 WHO Consolidated Guidelines focused on HIV, the revised Guidelines will focus on HIV, viral hepatitis and STIs among key populations. Was this shift important in your view?

The shift beyond HIV to include viral hepatitis and STIs brings a more holistic perspective of the interactions between belonging to priority populations and various risk factors HIV doesn't operate in a vacuum.

A lot can be shared and learnt by collaborating across infectious diseases at government, community, research, and clinical levels. Issues of human rights, criminalization, stigma, and discrimination all impact HIV, viral hepatitis and STIs. The experience of stigma is a shared experience across the priority communities.

Many of us are affected by multiple conditions and experiences and there are so many intersectionalities, as a queer woman of colour who injects drugs, it just makes sense to bring a wider lens to these issues rather than trying to put people into narrow boxes.

What can be done to make people who inject drugs globally more aware of the new Key Population Guidelines?

Well, community conversations are always a good place to start.

People who inject drugs are highly networked. It's important to consistently and constantly remind people who inject drugs about their inherent worth; we are beautiful human beings that deserve to be loved, have our human rights upheld, and be treated with respect, understanding, and compassion. The guidelines support these key messages.

Acknowledgement: we thank INPUD for conducting the interviews and writing this article and to the INPUD study participants who generously gave their time and offered their views.

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Consolidated guidelines on HIV, viral hepatitis and STI prevention, diagnosis, treatment and care for key populations - World - ReliefWeb

JERSEY CITY, N.J., Aug. 01, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Companys submission of a supplemental New Drug Application (sNDA) to expand the label of BREXAFEMME (ibrexafungerp tablets) to include the prevention of recurrent vulvovaginal candidiasis (RVVC). The FDA granted the submission Priority Review and assigned the Prescription Drug User Fee Act (PDUFA) target decision date as November 30, 2022.

If approved for this second indication, BREXAFEMME, an oral non-azole therapy, would be the first and only product approved in the U.S. for both the treatment of vulvovaginal candidiasis (VVC) and the prevention of RVVC, defined as three or more infections in a 12-month period.

The FDAs acceptance of this submission is excellent news for patients, and it brings us another step closer to our vision of addressing significant unmet needs in womens health, said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. Our pivotal CANDLE study was the basis of the sNDA submission, and we look forward to presenting details of these data to the medical community.

SCYNEXIS will present CANDLE study results this week at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting being held in Boston August 4-6, 2022.

Ibrexafungerp is designated by the FDA as a qualified infectious disease product (QIDP), allowing for a six-month priority review.

About BREXAFEMME(ibrexafungerp tablets)

BREXAFEMME is a novel oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Its mechanism of action, glucan synthase inhibition, is fungicidal againstCandidaspecies, meaning it kills fungal cells.BREXAFEMME was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. The approval was supported by positive results from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. BREXAFEMME represents the first approved drug in a new antifungal class in over 20 years and is the first and only treatment for vaginal yeast infections which is both oral and non-azole.

INDICATION

BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC).

DOSAGE AND ADMINISTRATION

The recommended dosage of BREXAFEMME is 300 mg (two tablets of 150 mg) twice a day for one day, for a total treatment dosage of 600 mg. BREXAFEMME may be taken with or without food.

IMPORTANT SAFETY INFORMATION

To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

For more information, visitwww.brexafemme.com. Please clickherefor Prescribing Information.

About SCYNEXIS

SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS scientists are developing the companys lead asset, ibrexafungerp, as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS launched its first commercial product in the U.S., BREXAFEMME(ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. In addition, clinical investigation and development of oral ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (VVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visitwww.scynexis.com.

Forward-Looking Statements

Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: progressing filing of an sNDA for RVVC, of ibrexafungerp, its potential use by physicians and patients in multiple healthcare settings. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS' ability to successfully develop and obtain FDA approval for ibrexafungerp for additional indications, including the IV formulation of ibrexafungerp; unexpected delays may occur in the timing of acceptance by the FDA of an NDA submission; the expected costs of studies and when they might begin or be concluded; SCYNEXIS need for additional capital resources; and SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies and commercialize its products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, including in each case under the caption "Risk Factors," and in other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT:

Investors:Irina KofflerLifeSci Advisorsikoffler@lifesciadvisors.com

Media:Debbie EtchisonSCYNEXISDebbie.Etchison@scynexis.com

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SCYNEXIS Announces U.S. Food and Drug Administration - GlobeNewswire

The pandemic, which has held the United States and almost every other country in its grip, should have taught us valuable lessons about how to manage a public health emergency, but it seems we are making some of the same mistakes we made not even three years ago, when the SARS-CoV-2 virus started to spread.

It is now clear: Preparedness alone does not guarantee a rapid response. With Covid-19, and now monkeypox, we were too slow to respond. It was as if we are sitting in a turbo-charged Ferrari, capable of massive acceleration, but instead only idling in the driveway.

Cavalry culture

Over the past three years, we have witnessed something counterintuitive. It was predominantly wealthy countries that were hit hardest during the Covid-19 pandemic. They had some of the highest death rates, despite their enormous resources.

While there are many reasons for this, including misinformation, lack of public trust, and the entangling of public health and politics, I think there is something else, as well: We have adopted what I call a "cavalry culture." We wait for the cavalry to ride in and rescue us, instead of taking smaller preventive steps -- such as establishing modern and reliable data systems, mastering our supply chain along the way, and acting early to head off the outbreak in the first place.

There are a couple of important axioms in public health. One is, by the time you think you must act to contain an outbreak, it is already too late. And, if you think you are overreacting, you are probably reacting just the right amount. In the case of Covid, and now monkeypox, we seem to have forgotten those basic public health principles. And, the real question now seems to be: When will the government finally hit the gas pedal on our highly tuned Ferrari?

I don't want to suggest any of this is easy. There are significant issues of uncertainty and unpredictability. Much like a hurricane forming at sea, we often don't know exactly where or how hard it will hit. We want to be measured, calm in our response and to cause as little disruption as possible. We want to be thoughtful and gather as much information as is available.

And therein lies one of our biggest problems: basic data. I have often wondered, how is it that a numbers-driven, high-tech country like the United States can't get basic data right?

Data disaster

As long as I've been reporting on the Covid pandemic, I have always had to offer the caveat that case numbers are probably off, sometimes wildly so. We have probably never had a clear vision on just how widely the virus was spreading at any given time in the United States, and going into the fall 2022, the situation isn't really any better.

"First, there's a lack of data access needed to understand where disease outbreaks are spreading. This is due to data collection limitations that Congress needs to fix," said Dr. Tom Frieden, president and CEO of Resolve to Save Lives and a former director of the US Centers for Disease Control and Prevention.

He said there is also a need to update analog systems and connect them to each other -- getting them to speak the same language. Right now, it's the Tower of Babel.

"Second, we lack sufficient numbers and, in some cases, skills of people and systems at the federal, state and local levels that can deliver services and communicate effectively with communities. Finally, we are in perpetual panic and neglect funding cycles," he said.

As a result of all of the things Frieden is describing, our current data collection and reporting system leaves important information fractured into dozens of states and territories, and thousands of county pieces for the CDC to puzzle together.

"I have been struck as we at CDC are now conquering another public health challenge -- monkeypox -- as to how little authority we at CDC have to receive the data," CDC Director Dr. Rochelle Walensky told the Washington Post.

Walensky is talking about basic data, like where the vaccine has gone, who has been vaccinated, whether the vaccine is working, and even monkeypox case data like who is getting infected, their age and race/ethnicity. Why might this be so?

"States don't routinely share vaccine doses administered data with the federal government -- Covid was really the first time that we were able to successfully put data use agreements in place," Claire Hannan, the executive director of the Association of Immunization Managers, told CNN. Part of the reason is because "states have laws in place to protect identifiable information."

Some information has been getting to the CDC, but it is challenging to get and incomplete. The CDC director told the Washington Post, "We have been speaking to our state and local partners probably at least three times a week, all of them. ... That is not how you synthesize data. We need ... standardization of those data, and we need to have those data come to us in a standardized fashion so that they can be connected, we can compile them and rapidly report them out. We cannot at CDC collect the data and make informed decisions by calling 64 jurisdictions, and honestly, 3,000 counties."

The CDC is currently working on agreements that would broaden the agency's access to states' data, as they successfully did with Covid. Hannan explained, "The need to quickly get the [monkeypox] vaccine out left no time to get data sharing agreements in place."

But even if those agreements were in place, it still doesn't mean the states' ability to actually obtain vaccine doses would be made any easier. That's because the states wouldn't be using the same data system for ordering and tracking doses they generally use. Because the US Department of Health and Human Services and the Administration for Strategic Preparedness and Response are in charge of monkeypox vaccine distribution, there would be yet another data system involved.

"They were asking states to request the vaccine using paper forms and email," said Hannan. "They were asking states to complete forms [with fillable fields] on those who were receiving the vaccine and return these forms to the federal government."

The problem was there weren't even the right fields for the specific questions being asked, such as reason for vaccination or type of exposure or risk, Hannan said. It wasn't that the necessary forms weren't being filled out, it was that they couldn't be filled out because of disparate data platforms.

It is a baffling level of bureaucracy in the middle of an unfolding outbreak.

Testing, vaccines, therapeutics

As things stand now, the issues with data collection, testing, vaccines, treatments and communication are sounding a lot like the ones we experienced with Covid-19.

The monkeypox outbreak is also different for another fundamental reason. Unlike with Covid, which was caused by a novel virus, the basic tools already exist either for monkeypox or its close relative, smallpox. We didn't have to build them from scratch. That means we could have had them or put them to better use by now.

Another tool that could be tremendously helpful is testing of wastewater. As we have seen with Covid, it can better define the scope of the outbreak and where it will emerge next. Two months into the outbreak, we still aren't doing this widely for monkeypox.

It also means that the vaccine, which can be given within 14 days of exposure (but preferably within four) to prevent or reduce the severity of disease, is currently being used more as a treatment -- a post-exposure prophylaxis -- rather than as a real preventive measure.

As National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said on CNN, that focus will have to shift.

"It's very clear with the spread of this that there now has to be a balance between vaccines available for those who clearly have been exposed, as well as those at risk," Fauci said. "What you want to do is a balance between vaccinating those who clearly have had an exposure but go well beyond that."

Finally, there is the issue of treatment. The CDC has made the antiviral smallpox treatment tecovirimat, called TPOXX, available to monkeypox patients who have or are at high risk of severe disease under an "alternate regulatory mechanism."

There are 1.7 million courses of TPOXX stockpiled. But once again, getting the medication to patients who could immediately benefit has proven to be bureaucratically burdensome for both patients and providers.

"You're talking about a five, six-day time lag to get that medication to you at a local doctor's office, no matter where you are. And the paperwork, and all of the bureaucracy to make that happen is very cumbersome, takes a few hours of your time. And that's the barrier," Dr. Stacy Lane, founder of the LGBTQ-centered Central Outreach Wellness Center in Pittsburgh, told me recently.

In the meantime, though, patients are suffering. Even though most cases are "mild," they are still uncomfortable, or downright painful, depending on where sores appear. Plus, there is a risk of long-term complications if the pox lesions develop in areas around the eye or GI tract.

All of these gaps have the hardest hit community on edge.

"Largely public health officials know how this has spread. They know how to vaccinate people ... we know how to treat it, and we know how to prevent it," says Samuel Garrett-Pate, managing director of external affairs of Equality California, the largest statewide LBGTQ+ civil rights organization.

"It unfortunately seems that despite two years of building up our public health infrastructure to prevent what happened with Covid-19 from ever happening again, despite the fact that we are better prepared in terms of already having a vaccine available, the CDC and FDA seem to be caught flat-footed once again. And I think as a result, you're seeing very real and understandable fear anxiety among the LGBTQ community."

Is it too late?

Dr. Scott Gottlieb, a former FDA commissioner and current board member of Pfizer, has been pessimistic about the trajectory of monkeypox in the United States.

"We're now at the cusp of this becoming an endemic virus, where this now becomes something that's persistent that we need to continue to deal with. I think the window for getting control of this and containing it probably has closed and if it hasn't closed, it's certainly starting to close," he said on Face the Nation on July 17.

CDC's Walensky pushed back on Gottlieb's assessment calling it "misinformed and off base," saying that while it's true there is much work to do, the US has made dramatic progress on priorities like testing, vaccines and education.

There has been measurable progress in these areas, no doubt. But, I do worry that we once again waited too long. We sat idling in our Ferrari, perhaps not wanting to believe that somehow we had suddenly found ourselves in the middle of yet another outbreak.

The world, however, is changing, as we have been reminded of twice in the last few years. There are new pathogens emerging, and existing pathogens are more easily traveling the world.

We have learned painful lessons in the last few years, and we are now in the midst of our first significant test since the Covid pandemic began, to see if we do any better this time around.

There is no doubt we are capable, and we are prepared. The question is will we use all those remarkable resources and respond, or we will wait and suffer until the cavalry has to rescue us once again?

CNN Health's Andrea Kane contributed to this report.

Read the original here:
Dr. Sanjay Gupta: While monkeypox cases rise, why are we waiting for the cavalry to rescue us? - CNN

Indigenous Milk Medicine Week Aug. 8-14; Asian American, Native Hawaiian and Pacific Islander Breastfeeding Week Aug. 15-21; Black Breastfeeding Week Aug. 25-31

LANSING, Mich. Michigan is committed to encouraging a strong foundation for life in all infants by supporting breastfeeding parents for the first year of their childs life and beyond. As part of this effort, Gov. Gretchen Whitmer has issued a proclamation declaring August 2022 as Breastfeeding Month.

During National Breastfeeding Month we recommit ourselves to supporting infants and new parents and ensure that every Michigander has equitable access to the resources and support they need to give their child a great start, said Governor Whitmer. We will work with Michigans health care providers and local organizations to broaden public understanding about the impact breastfeeding has on improving infant health and reducing infant mortality rates within communities of color across the state. I will work with anyone to ensure every baby in Michigan has what they need to grow up and pursue their potential.

Breastfeeding is a public health imperative central to successful health equity strategies that confront racism, classism and sexism which are the root causes of inequities and combatting these are a key strategy in reducing maternal and infant mortality. Disparities in breastfeeding rates and other maternal and infant health outcomes are most evident among Black and Indigenous families in Michigan. Increased efforts highlighting increased support to breastfeeding are part of Governor Whitmers Healthy Moms Healthy Babies initiative.

Proper nutrition for infants is critical for their growth and development, and it is important for hospitals, business, communities and coalitions to work together to provide consistent support for breastfeeding parents in Michigan, said Dr. Natasha Bagdasarian, MDHHS chief medical executive.

The American Academy of Pediatrics has updated its recommendation to breastfeed up to 2 years of age because of the benefits to the infant and the parent. Breastfeeding provides countless benefits to the nursing infant including easy digestion, production of antibodies and reduced risk of infections and childhood obesity. It also offers faster recovery from birth and reduced risk for postpartum hemorrhage and uterine cancer for the breastfeeding parent.

Ways to support breastfeeding include advocating for paid maternity leave and adequate pumping time while at work and school, and by bolstering Baby Friendly hospitals. National Breastfeeding Month is also a time to highlight under-resourced communities where families do not have equal access to support, care and education. The national formula shortage amplified how food disparities impact our most vulnerable populations, black and brown families. It has shown us the areas where improvement is needed to protect babies and ensure that parents are provided adequate prenatal breastfeeding education to make an informed decision.

Although 86.9% of Michigan families initiate breastfeeding, only 58% are still breastfeeding at three months (PRAMS 2020), and there are barriers such as lack of access to supportive health care and childcare providers and lack of paid work leave that leads to early weaning. Additionally, there are fewer lactation professionals from communities of color.

According to the Centers for Disease Control and Prevention, Black infants are 20% less likely to have ever received breast milk than any other race. In Michigan, seven of every 1,000 babies born die by age one, and among Black babies, the number is more than double. Between 80 and 90 maternal deaths occur each year with Black women dying 2.4% more often.

The states Women, Infants and Children (WIC) program is celebrating National Breastfeeding Month with the theme In Every Drop. Michigan is committed to encouraging to improving outcomes for breastfeeding parents and helping community health workers such as community-based doulas and the WIC Peer Counseling support program to help diversify lactation support and increase breastfeeding rates in local communities across the state.

WIC supports breastfeeding in the following ways:

For more information, visit Michigan WIC.

# # #

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Governor Whitmer declares August 2022 as Breastfeeding Month, highlights additional breastfeeding observances - Michigan (.gov)

Dr. Denise Johnson| Your Turn

Narcan carried by Erie Police to save lives

Erie Bureau of Police Lt. Anthony Talarico shows a portable naloxone kit, Nov. 7, 2016, at the police station in Erie. Naloxone is a medicine that reverses the effects of opioid overdoses, like those caused by heroin

Christopher Millette, Erie Times-News

Bringinghomea new baby is an exciting time for families, but it is also a significant life-changing experience that can cause stress for parents, caregivers and children. While all families benefit from support during the newborn stage, it is particularly important when the newborn has a health condition like Neonatal Abstinence Syndrome, or NAS.

NAS is a group of symptoms experienced by newborns who have been exposed to medications or substances during pregnancy. With symptoms ranging from excessive crying and crankiness to vomiting and trouble sleeping, managing the symptoms of this syndrome can be challenging for families. NAS can also impact an infant's development, so it is important for families to be connected to treatment and supportive services as soon as possible. This can be a difficult time when families deserve our compassion as well as the best support we can give.

More:Treat opioid use disorder and reduce maternal deaths by extending Medicaid postpartum

The treatment for babies born with this condition depends on the type and severity of symptoms that they are experiencing. Not all babies require lengthy hospital stays or medicines to help with NAS. A new parent can use The Eat, Sleep, Console (ESC) method, which focuses on the infant's ability to maintain the basic functions of eating, sleeping and consoling to help with symptoms of withdrawal. This approach emphasizes the relationship between mother and baby.And studies suggest it can decrease hospital stays and the need for medicine.

In the most recent report published by the Department of Health, there were 1,608 NAS cases reported by Pennsylvania hospitals and birthing facilities in 2019. The overall incidence rate across the state was 11.9 cases per 1,000 live births, a significant increase over the past two decades, and one public health officials are working to address.

More:Opioid crisis spurs Erie hospitals to help addicted pregnant women

The Wolf Administration remains committed to the fight against substance use and its impact on our fellow Pennsylvanians, especially our youngest residents. The department, in partnership with the Northwestern Pennsylvania NAS Coalition and Ohio Perinatal Quality Collaborative, developed a comprehensivetoolkitto walk families through their questions about NAS and let them know about the programs and services available to provide support to their infant and family.

Connecting families to health care and support is an important part of providing the necessary treatment to infants born with NAS. In addition to health care services that can be provided at birth, babies born with this health concern may be eligible for other special services. One example of a service that is available for diagnosed babies in Pennsylvania isEarly Intervention At-Risk Tracking, to help keep an eye out for any developmental delays.

In addition to connecting families to services, the Wolf Administration is working to better understand NAS in Pennsylvania. Hospitals and birthing facilities are required to report up to 28 days after birth all confirmed and probable cases in newborns who are showing symptoms of withdrawal due to prenatal exposure to opioids and other drugs whether via prescription, medical therapy or illegal use. By gathering this information, we can better understand the burden on families in Pennsylvania, identify high incidence areas to target interventions and reduce statewide incidence rates of NAS.

As we continue to fight substance use disorder across the commonwealth, we must remain steadfast in our efforts to provide needed services to infants born with NAS and their families. We must also take steps to prevent NAS by connecting individuals to treatment and reducing barriers to substance use treatment for all Pennsylvanians.

If you or someone you know is struggling with substance use, help is available. If you need assistance finding a treatment provider or funding for treatment, please call 1-800-662-HELP (4357) or contact yourlocal county drug and alcohol office. Additionally, the department is available to provide information to all families in Pennsylvania. For information and referrals related to the care of infants, please call our Healthy Baby Line at 1-800-986-BABY (2229).

Dr. Denise Johnson is the acting Pennsylvania Health Secretary and Pennsylvania Physician General.

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Babies born exposed to opioids and drugs need our support - GoErie.com

Wilmington, Delaware, United States, Transparency Market Research Inc.: The global centrifuge market was valued at ~US$ 1 Bn in 2019 and is projected to expand at a considerable CAGR from 2020 to 2030. Centrifuges can be defined as machines, which employ centrifugal force for the separation of substances of different densities, aids in removing moisture, and for stimulation of gravitational effects.

The global centrifuge market is driven by the growth of the life sciences industry, increasing prevalence of infectious diseases, growing research in genomics and proteomics, and increasing prevalence of blood related diseases leading to the demand for blood components

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Centrifuge Market: Segmentation

The global centrifuge market has been segmented based on product, model type, rotor design, intended use, application, end user, and region

In terms of product, the global centrifuge market has been categorized into equipment and accessories. The equipment segment is further segmented into multipurpose centrifuges, microcentrifuges (excluding minicentrifuges), ultracentrifuges, floor model centrifuges, and high speed centrifuges. The ultracentrifuges sub-segment is further divided into preparative ultracentrifuges and analytical ultracentrifuges. The accessories segment is further sub-segmented into rotors, tubes, centrifuge bottles, buckets, plates, and other accessories.

Based on model type, the global centrifuge market has been classified into benchtop centrifuges and floor-standing centrifuges. In terms of rotor type, centrifuge market can be segmented into fixed-angle rotors, swinging-bucket rotors, vertical rotors, and others. Based on intended use, the centrifuge market has been segmented into general purpose centrifuges, clinical centrifuges, and preclinical centrifuges.

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In terms of application, the global centrifuge market has been divided into clinical, research, and biotherapeutic manufacturing. The clinical segment is further segmented into diagnostics, blood component separation, and blood banking. The research segment is sub-segmented into microbiology, cellomics, genomics, proteomics, and others. The biotherapeutic manufacturing segment is sub-segmented into viral vectors, antibodies, hormones, nanoparticles, plasmid preparation, and vaccine manufacturing.

In terms of end user, the global centrifuge market is segmented into hospitals and blood banks, biotechnology & pharmaceutical companies, CROs, C(D)MOs, and academic & research institutions

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Centrifuge Market: Regional Segmentation

In terms of region, the global centrifuge market has been divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa

North America dominated the global centrifuge market in 2018 and the trend is expected to continue during the forecast period

The centrifuge market in Asia Pacific is anticipated to expand at a high CAGR from 2019 to 2027. Growth of the market in the region can be attributed to increase in the number of patients suffering from infectious diseases and focus of leading players on strengthening presence in emerging markets.

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Centrifuge Market: Major Players

These players focus on adopting inorganic growth strategies and product launches to strengthen their product portfolio. Thermo Fisher Scientific is one of the leading players in the centrifuge market. Its strong presence can be attributed to its extensive product portfolio and its strong brand recognition. Furthermore, the company strengthened its presence in the centrifuge market through a range of product launches over the years, including a range of blood banking centrifuges, Sorvall BP 8, and mini centrifuges. This enabled the company to enhance and expand its end user base.

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Centrifuge Market: Increasing Prevalence of Infectious Diseases to Drive the Market - BioSpace

Rheumatoid arthritis (RA) is an autoimmune disease that causes inflammation, swelling, and pain in a persons joints. The condition is chronic and progressive and can be disabling. Symptoms develop over time, with early signs including fatigue, joint tenderness, and pain.

According to the Arthritis Foundation, 1.5 million people in the United States have RA. Biological females are three times more likely than biological males to develop RA.

This article looks at the early signs that a person might have RA. It also discusses later stage symptoms and when to speak with a doctor.

If a person has an autoimmune disease, such as RA, their immune system mistakes the bodys cells for foreign invading cells. Their immune system then releases inflammatory chemicals to attack them.

If someone has RA, their immune system attacks the tissue called synovium. This tissue lines the joints and produces fluid that helps them move smoothly.

RA most commonly affects the joints in the hands, wrists, and knees. It causes the lining of the joints to become inflamed, which can damage their tissues. The damage that RA causes can lead to a person developing long lasting or chronic pain. It may also cause deformities and a lack of balance.

RA may also affect other tissues in a persons body, including organs such as the heart, eyes, and lungs.

A person can develop RA at any stage in their life. However, the condition most commonly develops between the ages of 30 and 50 years old.

People with early stage RA may not see redness and swelling in their joints. However, they may experience some joint tenderness and pain. A general feeling of stiffness throughout the body in the morning may suggest a person has RA.

Someone with early stage RA may also experience fatigue. Fatigue can be both mental and physical and can cause a person to feel extremely tired, preventing them from performing their usual daily tasks.

The inflammation that comes with RA may cause a person to develop a fever. A person has a fever if their body temperature rises above the typical range of 98100F (36.737.7C). Fever is a common sign of inflammation in people with autoimmune diseases.

A person may also experience weight loss due to the inflammation from RA. In addition, someone with fatigue and fever may experience appetite loss, which can contribute to weight loss.

As the inflammatory process of RA progresses, symptoms can worsen. A person may experience more extreme fatigue and continue to have fevers and lose weight.

Common symptoms of RA include the below.

Joint pain and stiffness is the most common symptom of RA. The persons joints may become red, warm, swollen, and tender to touch.

Joint stiffness is often at its worst in the morning. It can last for several hours or the entire day, depending on the severity of the disease.

RA tends to cause pain and stiffness in the hands and feet first. However, a person may experience these symptoms in the knees or shoulders.

RA will often affect both sides of a persons body. In fact, finding symmetrical symptoms across the joints is key to how doctors diagnose RA.

RA can cause damage to a persons ligaments and tendons. This can make it more difficult for them to achieve a typical range of motion in the joints. This can result in a person being unable to bend or straighten certain joints.

This can have a negative effect on their quality of life, as it may restrict them from doing things they were once able to do.

Inflammation from RA can cause nerve compression, which can affect the nerves around the joints. This can cause a person to develop damaged nerves, called peripheral neuropathy.

This nerve damage can cause a loss of sensation, and people may experience numbness or a tingling sensation in their hands and feet.

Rheumatoid nodules are lumps that develop under a persons skin. They are a common symptom of RA.

These lumps often appear next to the joints that the RA is affecting. However, rheumatoid nodules do not require treatment and are not contagious or dangerous. They can sometimes indicate that a person could make improvements to how they manage their RA.

RA mostly affects a persons joints. However, the disease can also affect other parts of the body, including the heart, lungs, and eyes.

This can cause a variety of other symptoms, including the following.

RA can affect a persons eyes. This can cause them to have dry eyes, the most common type of eye involvement in RA. People with RA can also experience increased sensitivity to light and trouble seeing clearly.

They may also experience eye pain and redness of the eye when RA inflammation affects the eye tissues, such as the iris or the uvea. This involvement is called iritis or uveitis, respectively.

RA can cause a person to have a dry mouth and inflamed gums.

People may also develop irritated gums or a gum infection.

According to a 2020 meta-analysis of 18 studies, up to 19.5% of people with RA may also have Sjgrens disease. This is a chronic autoimmune disorder affecting the moisture-producing glands, including those in the mouth.

RA can cause damage to a persons lungs, particularly in the form of interstitial lung disease, an umbrella term for a group of conditions that cause inflammation and scarring in the lungs.

This can cause the person to experience shortness of breath and may lead to chronic lung disease.

Inflammation can affect a persons blood vessels.

This can cause damage to their skin and nerves, resulting from inflammation of the veins, arterioles, and venules. The latter involvement can develop as a peripheral neuropathy.

A person with RA may also have anemia or a lower than expected red blood cell count due to the chronic inflammation.

A person with RA may experience inflammation of the heart. This can damage the heart muscle and the surrounding areas.

The chronic inflammation that RA causes can also increase the risk of developing coronary artery disease (CAD).

The inflammation affects the lipid profile of people with RA, contributing to the onset of CAD. People with RA are almost twice as likely to experience heart conditions, such as angina and congestive heart failure, as those without.

Some people with RA experience weight loss.

However, others may find that painful joints make it hard to exercise.

This can cause the person to gain weight. People who maintain a moderate weight can reduce their risk of high cholesterol, heart disease, and high blood pressure.

To treat RA effectively, it is important that a person gets an accurate diagnosis as soon as possible. If they experience symptoms of RA, they should seek medical help.

If a doctor suspects RA, they may arrange for the person to consult a rheumatologist, a doctor with specialized training in treating arthritis.

A doctor will first ask about the persons medical history before discussing joint symptoms. They will want to know about any pain, tenderness, stiffness, and any mobility difficulties they might be experiencing.

The doctor may also want to know about any family history of autoimmune diseases.

They will then carry out a thorough physical examination, documenting vital signs, examining joints, and looking for tenderness, swelling, or warmth of the joints. The doctor may also order blood and imaging tests to support the suspected diagnosis.

RA is a chronic autoimmune condition.

If a person has RA, their immune system confuses the bodys own cells for foreign invading pathogens. This causes the immune system to attack its own cells.

The immune system will also attack synovium, the tissue that lines the joints and produces fluid that helps them move smoothly.

RA tends to affect the joints in the hands, wrists, and knees.

Common symptoms of RA include swelling and pain in the joints, fatigue, fever, decreased function of joints, and compromised mobility.

Anyone who thinks they may have RA should consult with a doctor as soon as possible.

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How to tell if you have rheumatoid arthritis - Medical News Today