AI has perfect detection rate for severe cases of condition that causes blindness in preemies OHSU News
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AI has perfect detection rate for severe cases of condition that causes blindness in preemies - OHSU News
PulseSight launches with gene therapy platform targeting age-related blindness Longevity.Technology
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PulseSight launches with gene therapy platform targeting age-related blindness - Longevity.Technology
AIOS and RANZCO Unite to Combat Preventable Blindness Hindustan Times
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AIOS and RANZCO Unite to Combat Preventable Blindness - Hindustan Times
Baby born without eyes defies the odds as she thrives despite blindness Express
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Baby born without eyes defies the odds as she thrives despite blindness - Express
Penn Medicine Accelerator Program to Boost AI-Powered Projects Targeting Blindness and Cervical Cancer India Education Diary
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Penn Medicine Accelerator Program to Boost AI-Powered Projects Targeting Blindness and Cervical Cancer - India Education Diary
Scientists discover gut bacteria`s role in genetically-linked vision loss WION
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Scientists discover gut bacteria`s role in genetically-linked vision loss - WION
Revolutionizing Eye Disease Treatment: The Unseen Link Between Gut Bacteria and Blindness Medriva
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Revolutionizing Eye Disease Treatment: The Unseen Link Between Gut Bacteria and Blindness - Medriva
Prevent Blindness launches new Retinopathy of Prematurity Education and Support Program as part of inaugural ... Modern Retina
The Virtue of Color-Blindness & The End of Race Politics: Arguments for a Colorblind America Book Review National Review
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The Virtue of Color-Blindness & The End of Race Politics: Arguments for a Colorblind America Book Review - National Review
Sight loss could be treated by antibiotics after being linked to gut bacteria The Independent
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Prevent Blindness Launches New "Retinopathy of Prematurity (ROP) Education and Support Program" as Part of ... - PR Web
$35 million to fight blindness with manufactured corneas | Health Portfolio Ministers | Australian Government ... Department of Health
Eye conditions that can be targeted effectively with preventive strategies include congenital and acquired eye conditions, myopia, ocular trauma, and ocular infections and inflammations. A good example of this is the practice of preventative lifestyle changes among children, including a combination of increased time spent outdoors and decreased near-work activities. This may delay the onset and slow the progression of myopia, which reduces the risk of high myopia and its complications later in life.
Importantly, the prevention and management of systemic diseases, such as diabetes and hypertension, can also be effective in reducing the risk of ocular diseases. In addition, interventions to prevent vitamin A deficiency, measles and rubella, through vitamin A supplementation and immunization, are highly effective in reducing the risk of corneal opacities that can occur secondary to these conditions.
Another example is the prevention of workplace ocular injuries through promoting the use of protective eye equipment (e.g., masks, protective goggles, visors etc.) during high-risk activities and industries (e.g., certain sports, agricultural activities, construction workers, welders etc.).
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Eye care, vision impairment and blindness - World Health Organization (WHO)
A highly drug-resistant bacteria that was linked to eyedrops imported from India and that spread from person to person in a Connecticut long-term care center has prompted concerns that the strain could gain a foothold in U.S. health care settings, according to the Centers for Disease Control and Prevention.
Infectious disease specialists said the strain had not been previously detected in the United States, and that it was particularly difficult to treat with existing antibiotics.
In recent months, three deaths, eight cases of blindness and dozens of infections have been traced to EzriCare artificial tears, according to the C.D.C., leading to a widespread recall this year.
The Food and Drug Administration, which regulates over-the-counter medicine, has stopped imports of the product. But these outbreaks highlight regulatory gaps in controlling imports of overseas medications.
The F.D.A. confirmed that it had not inspected the factory where the eyedrops were made in India before the infections were reported, but that the agency had since visited the plant, which is operated by Global Pharma Healthcare.
The agency has long been criticized for lapses in inspections of overseas manufacturing in China and India, which are the two major producers of drugs and raw ingredients for medicines. Other instances of contaminated products from overseas included blood pressure medications suspected of containing a possible carcinogen and deadly batches of heparin, both of which prompted mass recalls.
The F.D.A. said it was continuing to work with the C.D.C. and had urged retailers to make sure the products were removed from shelves.
In the latest instance, the eyedrops are linked to bacteria that is even more drug-resistant than a similar bacteria that the C.D.C. tends to see in about 150 cases per year, mostly in intensive-care settings, according to Maroya Walters, lead investigator for the C.D.C.s antimicrobial resistance team.
Dr. Walters said the spread of the newest strain really could change the outlook for that.
The bacteria showed signs of spreading within the Connecticut center among asymptomatic patients who had the bacteria colonized in their bodies. Such spread tends to occur when patients touch common items or when health care workers transmit the germs.
The bacterium linked to the eyedrops, drug-resistant Pseudomonas aeruginosa, is already a top concern for health care providers, especially among those with compromised immune systems, nursing home residents and patients with invasive medical devices like catheters and breathing tubes.
Dr. David van Duin, an infectious disease specialist at the University of North Carolina School of Medicine, said resistant pseudomonas was especially difficult to eradicate, both from health care facilities, where it clings tenaciously to sink drains, water faucets and other moist environments, and from patients who develop bloodstream infections.
Its very hard to get rid of, he said.
By now, cases associated with the eyedrops have largely been contained, thanks to a product recall and widespread attention from the news media, Dr. Walters said. The F.D.A. had also announced the recall of Delsam Pharmas Artificial Eye ointment, which was made in the same factory as the eyedrops, because of possible contamination.
The C.D.C. is asking doctors to work with public health labs to determine the genetic fingerprint of hard-to-treat Pseudomonas infections in the eye and throughout the body.
I think we are going to see the impact of this play out over the course of months to years, Dr. Walters said.
In late December, the C.D.C. linked the EzriCare drops to an outbreak that has affected 68 patients in 16 states, including eight patients who lost their vision and four who had an eyeball removed.
The F.D.A. has not said how much of the product made by Global Pharma Healthcare in Chennai, India, was imported.
However, records provided to The New York Times by Panjiva, the supply chain research unit of S&P Global Market Intelligence, show that Global Pharma sent U.S. distributors four shipments in 2021 and 2022 amounting to tens of thousands of half-ounce bottles of EzriCare artificial tears.
While the F.D.A. requires a pre-approval inspection of plants that manufacture prescription drugs, there is no such mandate for those that make over-the-counter medicines like artificial tears. Compounding the problem, the number of inspections the agency conducts has plummeted since the pandemic began.
Representative Rosa DeLauro, Democrat of Connecticut, expressed concern about the F.D.A.s ability to oversee what she described as substandard safety practices at U.S. and foreign plants, and called for providing the agency with more funding and greater authority to recall products. Lives are at stake, she said in a statement.
On Jan. 3, the F.D.A. blocked Global Pharmas imports, saying the company had provided an inadequate response to a records request and violated manufacturing rules. Shannon P. Hatch, a spokeswoman for the agency, said that the import alert was unrelated to the outbreak.
The F.D.A. also said it recommended a voluntary recall on Feb. 2 over a lack of appropriate microbial testing, formulation issues and the absence of proper controls around tamper-evident packaging. The agency conducted an unannounced inspection at the India plant from Feb. 20 through March 2 and found a litany of problems with the plants sterility practices, according to an inspection report that was first reported by STAT news.
Clean-room operators were not qualified for the job, and they wore discolored and worn-out foot covers, the report said. An inspector noted a black, brown colored greasy deposit on machinery in a room where bottles were filled with the eye drops. One worker acknowledged to an inspector that there was no procedure for cleaning one of the filling machines, according to the report.
Global Pharma did not respond to questions in March. But on Feb. 1, the company said it had not determined whether our manufacturing facility is the source of the contamination. EzriCare said on its website that it marketed the drops, but that it had no role in the actual manufacturing of this product. Wal-Mart and Amazon, among the larger retailers that sold the drops, did not respond to requests for comment.
Clara Elvira Oliva, 68, a contact lens wearer from Florida, began using EzriCare Artificial Tears to moisturize her eyes at the recommendation of the ophthalmologist at her health clinic.
One morning in August, she woke up to find her right eye red and itchy and oozing liquid. Alarmed, she returned that day to the ophthalmologist, who prescribed antibiotic drops. But in the weeks that followed, she said, the irritation persisted and her eyesight began to deteriorate, stumping eye care providers who prescribed an ever-changing variety of antibiotic and antifungal drops.
All the while, she kept using the EzriCare drops in both eyes. No one told me to stop using them, Ms. Oliva said in an interview.
By the end of August, the infection in her right eye had become so dire that specialists told her she would need a cornea transplant. After the operation, she was told the eye was so ravaged by infection that doctors had no choice but to remove it.
Since that day, my life has never been the same, said Ms. Oliva, a retired cosmetologist who lives with her son in Miramar.
Dr. Walters collected mounting reports of antibiotic-resistant infections in several states that had a strikingly similar genetic fingerprint.
C.D.C. investigators examined an outbreak of about two dozen cases at the long-term care center in Connecticut, where they saw evidence of bacterial spread among residents. That investigation pointed to eyedrops, but the centers records made it difficult to tell what type had been used.
By late December, the C.D.C. had tested 23 open bottles of eyedrops. Eleven of the EzriCare artificial tear bottles harbored bacteria, and seven of those matched the outbreak strain, Dr. Walters said.
While the finding is not definitive proof that the bacteria came from the bottle and not from touching an infected eye, the evidence was compelling, Dr. Walters said.
For Ms. Oliva, the vision in her left eye, already compromised by scarring, continues to deteriorate, making it difficult to drive, cook and read. Unsteady on her feet, she avoids going out. Sometimes I bump into people because I dont see them, but they think Im just not paying attention, she said.
Ms. Olivas lawyer, Natasha Cortes, said she was investigating two cases of patients who went to the same clinic and developed vision problems, as well as five others.
The outbreak has renewed longstanding concerns about the quality and frequency of the F.D.A.s overseas inspections.
In June 2020, Senator Chuck Grassley, Republican of Iowa, held an oversight hearing on the F.D.A.s foreign inspection process, noting that the plants were given 12 weeks advance notice, plenty of time to doctor up a facility to make sure that it passes inspection. The agency has since received budget authority to conduct unannounced overseas inspections.
The F.D.A. paused overseas inspections during the height of the coronavirus pandemic, and the number of foreign inspections remained low last year, at 684 compared with 3,272 in 2019, according to agency data.
The F.D.A. has 4,000 overseas facilities to inspect, with about 20 percent in India; one of its six inspector positions in that country was vacant in late 2021, according to a report issued last year by the Government Accountability Office.
For over-the-counter drugs, the F.D.A. uses a system that essentially lists a medication recipe. Companies can make the products without express agency approval but are expected to follow agency rules for manufacturing quality products, said John Serio, a lawyer with Withers who has pharmaceutical clients.
If youre not out there inspecting facilities, Mr. Serio said, these sorts of problems will crop up because theres no threat that if youre out of compliance that the inspector will come knocking at your door.
Dr. Vicente Diaz, the chief of ophthalmology at Yale Health Plan in Connecticut who specializes in infectious diseases, said the infections evading the big gun antibiotics had alarmed experts. He worries that if doctors use ineffective antibiotics for too long or wait to culture a bug, that gives the bacteria more time to multiply and get more aggressive, he said.
EzriCare drops do not contain preservatives, a fact that Dr. Diaz found troubling. He said he had never seen another reusable eye product without preservatives or other safety features to limit bacterial growth. Preservative-free drops usually come in single-use bottles, given the risk, he said.
Im surprised that formulation was allowed to go on the market without more scrutiny, he said. Its kind of like the perfect storm.
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Drug-Resistant Bacteria Tied to Eyedrops Can Spread Person to Person ...
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Prevention of Blindness Week 2023: Mumbai experts explain why you should be concerned about glaucoma and the need for regular eye checkups -...
Medical condition
Childhood blindness is an important contribution to the national prevalence of the disability of blindness.[3] Blindness in children can be defined as a visual acuity of <3/60 in the eye with better vision of a child under 16 years of age.[4] This generally means that the child cannot see an object 10 feet (about 3 meters) away, that another child could see if it was 200 feet (about 60 meters) away.[5]
There are many causes of blindness in children. Blindness may be due to genetic mutations, birth defects, premature birth, nutritional deficiencies, infections, injuries, and other causes. Severe retinopathy of prematurity (ROP), cataracts, Vitamin A deficiency, measles, conjunctivitis and refractive error are also causes.[6][7]
Vitamin A deficiency is most common in developing countries where many kids experience malnourishment. This vitamin deficiency blinds hundreds of thousands of kids each year, and is a preventable cause of childhood blindness. Since vitamin A is required for rhodopsin, the photosensitive pigment in the retinol rods, its deficiency can lead to night blindness.[8]
Since 2010, globally 85% of children have been vaccinated for measles significantly reducing the number of measles cases each year. Children who have a vitamin A deficiency and measles infection can develop corneal ulcerations and keratomalacia due to immunosuppression caused by the vitamin deficiency.[8]
Newborn conjunctivitis is present at the time of birth and presents within the first 28 days of life as a severe conjunctival infection with purulent discharge. This increases the risk of corneal ulcerations and perforations that can lead to blindness. The common organisms that lead to this diagnosis include Neisseria gonorrhoea and Chlamydia trachomatis. Infected pregnant women and their partners should be treated to avoid infection of the newborn, and newborns presenting with conjunctivitis should be treated with hourly topical antibiotic drops (gentamicin). [8]
Retinopathy of Prematurity (ROP) is classified by the abnormal growth of blood vessels in the retina, a process called retinal neovascularization.[9] These blood vessels may bleed or grow in the wrong direction. Bleeding can lead to the formation of scar tissue which can cause blurred vision and vision loss. If the vessels grow too far in the wrong direction, they can pull the retina away from the back of the eye this is called retinal detachment. Retinal detachment is a medical emergency that can cause permanent blindness and thus requires urgent intervention.[10]
Babies who are born prematurely (formally defined as 37 weeks of gestational age or earlier) are at higher risk of developing retinopathy of prematurity. The earlier a preterm baby is born, the greater the baby's risk of developing ROP. Blood vessels in the eye typically finish development by the time of birth. Therefore, a baby who is born early is exposed to various stimuli (oxygen, lights, temperature, etc.) that may influence how the blood vessels of the eye develop. Additional risk factors for ROP include low birth weight (3 pounds or less) and giving the baby extra oxygen following birth. If preterm infants are experiencing other health problems like anemia, vitamin E deficiency, and/or breathing problems, they are at increased risk of developing ROP.[11]
Childhood blindness has many causes.[12] Leading causes include retinopathy of prematurity, vitamin A deficiency, infectious diseases (measles, newborn conjunctivitis), retinoblastoma, and congenital conditions (cataracts and glaucoma).[13] Leber congenital amaurosis primarily affects the retina, and typically severe visual impairment begins in infancy. Mutations in Aryl hydrocarbon receptor interacting protein like-1 have been linked to Leber congenital amaurosis (LCA).[14]
The most frequently affected parts of the eyes are:[15][16]
The diagnosis of childhood blindness is done via methods to ascertain the degree of visual impairment in the affected child. Early detection is essential to provide early intervention to children. The American Academy of Ophthalmology recommend various screening methods starting in newborns and spanning throughout childhood in order to assess for childhood blindness and other ophthalmic disorders. Newborns are screened with the red reflex test performed by shining a light into the child's eyes. If a red reflex is not produced, further workups should be done to assess for congenital cataracts or retinoblastoma. From 6-12 months, children are screened at their well-child visits with the red reflex test, assessment of eye movement, and proper pupil dilation. From 1 year to 3 years of age, children often undergo a "photoscreening" test where a camera takes pictures of the child's eyes to assess for developmental abnormalities that may lead to amblyopia. Children ages 3 to 5 years of age will be assessed for proper eye alignment and visual acuity. Visual acuity is assessed with a Snellen chart with lines of letters that the child reads and helps determine visual acuity.[17]
The chemical structure of Vitamin A (one of many chemical forms)
Vitamin A deficiency is a leading cause of preventable childhood blindness, particularly in developing countries. Vitamin A deficiency is defined as a serum (blood) concentration of less than 0.70 mol/L while a severe deficiency is defined as less than 0.35 mol/L, per the Centers of Disease Control National Health and Nutrition Examination Survey.[18] Vitamin A is supplied through the diet, and a deficiency often results from poor dietary intake of Vitamin A-rich foods.[19] Low dietary levels of Vitamin A can be worsened by infections that cause inflammation in the gastrointestinal tract, which prevent the body from fully absorbing Vitamin A available within digested food. Children in the United States have a recommended Vitamin A dietary allowance of at least 300 micrograms/day.[19] Good sources of Vitamin A include vegetables, such as carrots, papaya, and pumpkin.[20] Animal products, such as fish oils, as well as dairy products (milk, cheese, and yogurt) are also sources of Vitamin A.[20]
Retinopathy of prematurity (ROP) is a cause of childhood blindness that can occur around the time of birth. Generally, measures taken to avoid preterm birth are also effective at preventing ROP. Babies delivered preterm, defined at or before 37 weeks of gestation, have incomplete development of the blood vessels supplying the retina.[21] At birth, increased exposure to oxygen from the environment and from medical interventions (such as a high flow nasal cannula) causes damage to retinal blood vessels and stunts their growth. Prevention of ROP in preterm babies involves careful monitoring of oxygen delivery to avoid excess exposure.[22] Neonatal ocular exams can help detect ROP.[23]
Whether blindness is treatable depends upon the cause.[24] Surgical intervention can be performed in cases of primary congenital glaucoma. A 2020 review found no difference between combined trabeculotomy and trabeculectomy (CTT) and routine conventional trabeculotomy, or between viscotrabeculotomy and routine conventional trabeculotomy. The review also found that the 360-degree circumferential trabeculotomy may show greater surgical success than conventional trabeculotomy but that further research with one year follow-up was needed.[25]
Braille is a universal way to learn how to read and write, for the blind.[26] A refreshable braille display is an assistive learning device that can help such children in school.[27] Schools for the blind are a form of management, however the limitations of using studies done in such schools has been recognized. Children that are enrolled presently usually developed blindness 5 or more years prior to enrollment, consequently not reflecting current possible causes.[28] About 66% of children with visual impairment also have one other disability (comorbidity), be it, intellectual disabilities, cerebral palsy, or hearing loss.[29] Eye care/screening for children within primary health care is important, as catching ocular disease issues can lead to better outcomes overall.[30]
Globally, the number children with blindness is approximately 1.4 million, representing 4% of the global blind population, and an additional 17.5 million are at risk of developing poor vision.[31] Although this number is significantly lower than the number of blind adults, the estimated economic and social burden of blindness for children is much greater due to the increase in blind years. Childhood blindness is most prevalent among children with genetic ancestry from Africa and Asia, who represent 75% of the world's affected population.[13][32] A 2014 review indicated that an estimated 238,500 children with bilateral blindness (rate 1.2/1,000) live in the Eastern Mediterranean region.[30] There is also an increase in blindness outside of developing countries due to a lack of screening and prophylactic measures to treat causes of pediatric blindness.[33]
VISION 2020 is a program launched by the International Agency for the Prevention of Blindness (IAPB) and is supported by the WHO in 1999 that has made controlling blindness in children a high priority.[34] In addition, the IAPB and WHO coordinate "World Sight Day" on the second Thursday of October each year.[35] Starting in 2000, World Sight Day has become an opportunity to raise awareness of eye health and highlight the importance of increasing access to eye health services globally. It has also become a tool to influence governments around the world to allocate funds for blindness prevention programs and educational initiatives.
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Childhood blindness - Wikipedia
FDA Approves Syfovre (pegcetacoplan injection) for the Treatment of Geographic Atrophy, a Leading Cause of Blindness
WALTHAM, Mass., Feb. 17, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the U.S. Food and Drug Administration (FDA) has approved Syfovre (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Syfovre is the first and only FDA-approved treatment for GA, a leading cause of blindness that impacts more than one million people in the U.S. and five million people worldwide.1,2
The approval of Syfovre is the most important event in retinal ophthalmology in more than a decade, said Eleonora Lad, M.D., Ph.D., lead investigator for the OAKS study, director of ophthalmology clinical research, associate professor of ophthalmology, Duke University Medical Center. Until now, there have been no approved therapies to offer people living with GA as their vision relentlessly declined. With Syfovre, we finally have a safe and effective GA treatment for this devastating disease, with increasing effects over time.
Today marks an extraordinary milestone for patients, the retina community, and Apellis. With its increasing effects over time and flexible dosing, we believe that Syfovre will make a meaningful difference in the lives of people with GA, said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer, Apellis. GA is a complex disease that the field has spent decades trying to address, so we are humbled and proud to bring forward the first-ever treatment. Thank you to all who helped make this moment a reality.
The approval of Syfovre is based on positive results from the Phase 3 OAKS and DERBY studies at 24 months across a broad and representative population of patients. Syfovre is approved for GA patients with or without subfoveal involvement and provides dosing flexibility for patients and physicians with a dosing regimen of every 25 to 60 days. In the OAKS and DERBY studies, Syfovre reduced the rate of GA lesion growth compared to sham and demonstrated increasing treatment effects over time, with the greatest benefit (up to 36% reduction in lesion growth with monthly treatment in DERBY) occurring between months 18-24.
For the first time ever, we are celebrating the approval of a treatment for GA, said Jeff Todd, president and chief executive officer, Prevent Blindness. This is a historic and hopeful day for all GA patients and their care partners, who have been waiting for a treatment for this relentless form of vision loss.
GA is an advanced form of AMD. It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. On average, it takes only 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.3
The safety profile of Syfovre is well-demonstrated following ~12,000 injections. The most common adverse reactions ( 5%) reported in patients receiving Syfovre were ocular discomfort, neovascular AMD, vitreous floaters, and conjunctival hemorrhage.
Apellis is committed to helping patients with treatment access and support. ApellisAssist is a program designed to help Syfovre patients along their treatment journey by providing a system inclusive of insurance support, financial assistance for eligible patients, disease education, and ongoing product support. Patients and healthcare providers can call 1-888-273-5547 for more information.
Syfovre is expected to be available by the beginning of March through specialty distributors and specialty pharmacies nationwide. A marketing authorization application for Syfovre is under review by the European Medicines Agency with a decision expected in early 2024. In addition, a marketing application has been submitted to Health Canada.
About the Phase 3 OAKS and DERBY StudiesOAKS (n=637) and DERBY (n=621) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of Syfovre (pegcetacoplan injection) with sham injections across a broad and representative population of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The studies evaluated the efficacy of monthly and every-other-month Syfovre in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence at 24 months.
Both monthly and every-other-month (EOM) Syfovre reduced the rate of GA lesion growth through 24 months compared to sham:
About Syfovre (pegcetacoplan injection) Syfovre (pegcetacoplan injection) is the first and only approved therapy for geographic atrophy (GA). By targeting C3, Syfovre is designed to provide comprehensive control of the complement cascade, part of the bodys immune system. Syfovre is approved in the United States for the treatment of GA secondary to age-related macular degeneration.
U.S. Important Safety Information for Syfovre (pegcetacoplan injection)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
About Apellis Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn.
Apellis Forward-Looking Statement Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding timing of the commercial availability of Syfovre. The words anticipate, believe, continue, could, estimate, expect, intend, may, plan, potential, predict, project, should, target, will, would and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Syfovre will be commercially available when expected; whether clinical trials of Syfovre indicate an apparent positive effect that is greater than the actual positive effect, whether Syfovre will receive approval from foreign regulatory agencies for GA when expected or at all; and other factors discussed in the Risk Factors section of Apellis Annual Report on Form 10-K with the Securities and Exchange Commission on February 28, 2022 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
1 Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571580.2 Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106116.3 Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.
Posted: February 2023
Syfovre (pegcetacoplan) FDA Approval History
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New research has shown that human mini brains can integrate with damaged rat brains to perform functions related to sight a promising step toward a future where lab-grown brain tissue can reverse blindness in people.
The challenge: If the visual cortex the part of the brain that receives and processes information from the eyes is damaged by injury or disease, a person can lose their ability to see.
We still didnt know if organoids implanted in the visual cortex would actually function like natural brain tissue.
Researchers have speculated that grafting brain organoids clumps of lab-grown cells that mimic the structure of real brain tissue onto a damaged visual cortex might give people back some or even all of their vision.
This area of study is still very new, but prior research has shown that the brains of baby rats will accept and integrate grafts from human mini brains. It was a promising sign, but we still didnt know if organoids implanted in the visual cortex would actually function like natural brain tissue.
Whats new? To find out, researchers at the University of Pennsylvania grew brain organoids in their lab for 80 days. They then grafted the clumps of cells into the brains of 46 rats that had sustained injuries to their visual cortices.
After three months, about 82% of the grafts had successfully integrated into the rats brains the lab-grown cells grew in size and number, formed synapses with the rats own neurons, and developed healthy vasculatures.
These organoid neuronswere able to adopt very specific functions of the visual cortex.
To figure out whether the human mini brains were actually becoming functioning parts of the visual cortex, the researchers used fluorescent viruses, which use synapses to travel between neurons, to map the neural network.
By injecting one of these viral tracers into the eye of the animal, we were able to trace the neuronal connections downstream from the retina, said senior author H. Isaac Chen. The tracer got all the way to the organoid.
Once they knew these specific connections had formed between the rats brains and the organoids, the researchers connected electrodes to neurons in the transplanted mini brains. Those allowed them to measure activity in the organoids while the rats were exposed to flashing lights.
We saw that a good number of neurons within the organoid responded to specific orientations of light, which gives us evidence that these organoid neurons were able to not just integrate with the visual system, but they were able to adopt very specific functions of the visual cortex, said Chen.
The caveats: While about 75% of the neurons in the rats own visual cortices responded to the light stimulation, only 20% of those in the grafted human mini brains did.
[T]here were fewer neurons that responded to light than ideal, Chen told Technology Networks. Understanding how to improve this response rate/integration is one of our primary goals for the future.
Neural tissues have the potential to rebuild areas of the injured brain.
The type of vision-impairing damage sustained by the rodents in the study isnt exactly the same type that typically causes blindness in people, either, so thats another area ripe for future study.
[W]hile the aspiration cavity we made is a brain injury of sorts, it is not a good model for conditions like traumatic brain injury and stroke, said Chen. We would like to move our transplantation studies into these types of models in the future.
Looking ahead: As is the case with all rat studies, theres a chance humans would respond to this procedure in a completely different way, so much more research is needed before anyone could try using organoids to repair brain damage in people.
The researchers believe the potential is huge, however.
Neural tissues have the potential to rebuild areas of the injured brain, said Chen. We havent worked everything out, but this is a very solid first step.
Wed love to hear from you! If you have a comment about this article or if you have a tip for a future Freethink story, please email us at [emailprotected].
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Human mini brains illuminate path to curing blindness