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Eye exercises can help alleviate vertigo. A doctor may recommend eye exercises as part of an extended therapy programme that includes other types of physical therapy.

Vertigo is not a condition but a symptom of several potential underlying conditions.

When a person follows the recommendation of a doctor or health professional, eye exercises can provide safe and effective therapy for vertigo.

This article reviews different eye exercises that can alleviate vertigo, as well as other exercises and treatments that may help.

Vertigo involves the sensation of spinning. A person with vertigo may feel like they or their surroundings are moving or spinning.

There are two types of vertigo: peripheral and central.

According to a 2021 publication, 80% of vertigo cases are due to peripheral vertigo. This type is often the result of benign paroxysmal positional vertigo (BPPV), which occurs when carbonate crystals in the ear become displaced.

Central vertigo accounts for the remaining 20% of cases. This type of vertigo results from lesions on the brain stem or other issues that affect the brain.

Both multiple sclerosis and migraine can cause central vertigo.

Eye exercises make up part of a type of therapy called vestibular rehabilitation therapy (VRT). VRT can provide effective therapy for vertigo resulting from:

Eye exercises may work to alleviate vertigo because they help a person adjust and maintain balance.

Doing exercises that involve moving the eyes and head can help people adapt to these movements, training their bodies to adjust to vertigo triggers.

The hope is this will reduce vertigo as a person gets used to the movements over time.

However, a doctor will recommend different exercises depending on the underlying cause of vertigo.

A person should speak with a doctor or healthcare professional before trying any of these exercises as they could be ineffective or worsen vertigo, depending on the underlying conditions.

Several eye-related exercises may help a person improve their vertigo.

Before beginning any exercise program, a person should consult a physical therapist or doctor. They may have other recommendations or exercises they would like the person to practice.

The following exercises are part of a VRT program. A person should make sure to conduct the exercises in a safe and comfortable environment, as they could trigger dizziness.

It is best to start the exercises slowly, doing them for a few seconds and gradually increasing the time as a person adjusts to each exercise.

However, how long and how often a person should do these exercises depends on the underlying cause of the vertigo. Therefore, a person should talk with a doctor about the following exercises before trying them.

To do this exercise, a person should follow these steps:

This exercise involves keeping the head still while moving the eyes.

To do this exercise, a person should:

This exercise involves keeping the head still and moving the eyes quickly.

To conduct this exercise, a person can:

To do this exercise, a person should:

To follow this exercise, a person should:

Several other exercises can help with treating vertigo. The following are two examples of exercises that may effectively treat vertigo associated with BPPV.

A person should talk with their doctor or therapist before starting any new exercises. They should follow their treatment recommendations.

This is a canalith repositioning exercise that may help treat BPPV.

To conduct this exercise, a person can follow these steps:

A person should repeat the same movement on the opposite side. This means they would face the left at the beginning.

A person can perform this exercise up to three times per day.

Learn more about the Epley maneuver with a step-by-step video guide.

The half somersault maneuver (HSM) is also known as the Foster maneuver. A 2021 study found that the HSM was more effective in treating BPPV than the Epley maneuver.

To conduct this exercise, a person should:

A person may feel dizzy between the steps. If this happens, they should allow the dizziness to subside before going to the next step. Each position should be held for 15 seconds if there is no dizziness.

Learn about other exercises that can alleviate vertigo.

In addition to exercises, a doctor may recommend other treatments for vertigo.

Experts have found that certain medications can help with vertigo, such as antihistamines, benzodiazepines, and antiemetics. A doctor may recommend a combination of medication and exercises or may prescribe one or the other.

For some causes of vertigo, a person may find that dietary changes help. For example, a person living with Mnires disease may find that reducing their intake of salt, alcohol, and caffeine may help.

With treatment, a person should find that their vertigo improves over time. However, it is possible for symptoms to return.

For example, about 50% of people living with BPPV experience a relapse within 5 years. Also, about one-third of people who experience vertigo from anxiety will still experience symptoms after 1 year.

If vertigo is a symptom of an underlying condition, treating the condition should help to alleviate or eliminate vertigo.

A person should talk with a doctor to determine the underlying cause and find out how they can treat it.

Eye exercises may help people improve their vertigo when paired with head movements. Additionally, several other exercises, such as the Epley maneuver and the half somersault maneuver, can help a person alleviate vertigo.

In some cases, a doctor may recommend medication and lifestyle changes to help alleviate or eliminate vertigo.

Most people should see at least some improvement in their vertigo following treatment, though it is possible to experience a return of symptoms after some time.

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Eye exercises for vertigo: Exercises to try at home - Medical News Today

Eye movement desensitization and reprocessing, or EMDR, is a technique that some psychotherapists use to treat people experiencing psychological distress.

Research suggests that EMDR is a relatively safe and effective therapy. Organizations such as the World Health Organization (WHO) and the American Psychiatric Association (APA) recommend it for people with post-traumatic stress disorder (PTSD).

In this article, we discuss the potential benefits of EMDR and look at the research behind it.

Francine Shapiro, an American psychologist, developed EMDR therapy in the late 1980s.

Practitioners initially used it to treat people with traumatic memories, but they now use it to treat a variety of disorders, including:

The therapy consists of eight phases. During the treatment, people recall traumatic experiences while moving their eyes back and forth. The therapist will direct this eye movement.

The aim is to allow people to process and integrate these traumatic memories into their standard memories. The theory behind this method is that remembering times of distress while distracted is less upsetting. Over time, exposure to these memories should reduce their effects.

EMDR is similar in some respects to cognitive behavioral therapy (CBT) another PTSD treatment as it involves remembering or discussing the traumatic event as well as identifying and altering the thoughts.

These processes are called exposure and cognition.

The theory behind EMDR is that traumatic memories make changes in the brain. These changes stop the mind from processing information properly, which causes anxiety and intrusive thoughts.

Experts believe that remembering the traumatic events while performing rapid eye movements allows the brain to process these memories correctly and integrate them into the story of the persons life.

The eight phases of EMDR therapy are as follows:

The therapist will evaluate the clients case, including their ability to tolerate exposure to distressing memories.

They will then formulate the treatment plan based on the persons symptoms and the behaviors that need modifying.

The therapist will lay the groundwork for the treatment by establishing a therapeutic relationship with the client and educating them on EMDR.

They will also teach the person self-control techniques, which are ways to cope with distressing memories that arise.

During this phase, the therapist will identify the traumatic memories that the client needs to address.

The client will then choose an image to represent each memory, noting the negative beliefs and physical sensations that accompany these memories. They will then identify a positive thought to replace the negative beliefs.

Desensitization involves reducing the clients disturbing reactions to the traumatic memory, including the physical sensations that they have when thinking of it.

Physical sensations may include a rapid heart rate, sweating, or stomach problems.

The therapist facilitates desensitization by directing the clients eye movements while they focus on the traumatic material.

The focus of this stage is on installing the positive thoughts that the client identified in phase 3.

A body scan is a meditative technique in which a person scans their body from head to toe to notice the physical sensations that are occurring.

During EMDR, the therapist will target these physical sensations for further processing.

At the end of each session, the therapist will stabilize the client using the self-control techniques that they discussed in phase 2.

The therapist will explain what the client can expect between sessions. They will also ask the client to keep a record of any negative experiences that occur so that they can target them in the next meeting.

The final phase involves a review of the effectiveness of the treatment so far. The therapist and client will also identify any additional traumatic effects to target.

Most of the research on EMDR looks at its benefits for people with PTSD and other trauma-related symptoms.

Research suggests that EMDR may also treat symptoms that accompany a traumatic experience, such as self-harm, stress, and anger.

However, practitioners use it to treat a variety of other conditions and issues, including:

Preliminary research supports its application for some of these issues, such as psychotic symptoms and chronic pain.

In some cases, people may choose to do EMDR alongside other treatment options for the best results.

According to the EMDR Institute, more than 30 controlled outcome studies on EMDR therapy have shown that it has positive effects.

In some of these studies, as many as 90% of trauma survivors appeared to have no PTSD symptoms after just three sessions.

Other studies that the EMDR Institute cite showed very positive outcomes for the majority of participants after six to 12 sessions.

Organizations such as the WHO, the APA, and the Department of Veterans Affairs currently recommend EMDR as a treatment option for PTSD.

A 2014 research study looked at 24 randomized controlled trials that support the effectiveness of EMDR therapy for the treatment of trauma. The results of some of these studies suggested that EMDR therapy is more effective than CBT for trauma.

Some research indicates that EMDR may be effective for other mental health issues. For example, it may have a positive effect on psychotic symptoms (in people with both psychosis and PTSD), such as:

Research also suggests that the benefits of EMDR persist over time. The authors of a small 2015 study reported that people who underwent EMDR treatment for depression were less likely than those in the control group to experience relapse or problems relating to depression in the year following treatment.

However, many of the studies on EMDR have small sample sizes and limited follow-up information.

As a result, several researchers have called for additional research into the treatment.

Doctors generally consider EMDR therapy to be a safe treatment. It typically causes fewer adverse reactions than medications for depression and trauma symptoms.

Also, unlike some medications, EMDR may maintain its effectiveness after treatment ends.

Even so, EMDR and other forms of psychotherapy may cause some side effects, such as:

These symptoms will typically resolve as treatment continues. Individuals should tell their therapist about their experiences between sessions so that they can work on new memories and symptoms in future sessions.

Individuals who would like to know more about EMDR should speak to a doctor or mental health professional who specializes in the practice.

Questions to ask include:

Therapists have been using EMDR for more than 25 years to treat PTSD and other mental health conditions. A growing body of research suggests that it is effective and safe in reducing distress, anxiety, and other symptoms.

People who would like to know more about EMDR treatment should speak to their doctor or a licensed therapist.

Originally posted here:

EMDR therapy: Everything you need to know - Medical News Today

Eye floaters are dots or specks in a persons vision that seem to float away when the person tries to look directly at them. They are made up of the vitreous of the eye, and in most cases, they are completely normal. The vitreous is the clear, gel-like substance that fills out most of the eye.

Eye floaters do not usually require treatment, as they themselves do not cause any harm to the sight. However, in some cases, eye floaters may make it difficult to see and will require removal to restore sight.

Eye floaters may also be an early sign of an underlying issue, such as damage to the retina.

Eye floaters are a natural phenomenon due to the vitreous body of the eye. The vitreous helps give the eye its round shape.

Floaters occur when this vitreous body starts to shrink. As it shrinks, little fibers can break away and become stringy. This is what doctors call vitreous detachment.

This detachment causes stringy masses of vitreous that can disrupt light coming into the retina. This casts a tiny shadow into the eye, which is what makes floaters noticeable.

Eye floaters are a normal part of the aging process. The American Society of Retina Specialists note that conditions such as vitreous detachment, which causes more floaters, are more common after the age of 60.

Everyone can get eye floaters at some point, though most people ignore them. Many may only notice them when they look at a blank, bright surface or area such as the sky.

Although they can be distracting at first, most eye floaters tend to settle down to the bottom of the eye, beneath the field of vision.

However, the American Society of Retina Specialists recommend that a person who notices sudden symptoms such as floaters get checkups with an ophthalmologist within the first few months after the symptoms appear, to check for any signs of more serious issues.

Although some floaters in the eye may be a normal part of the aging process, experiencing a sudden increase of floaters in the eye may be a sign of another issue, such as retinal detachment.

When retinal detachment occurs, it is not uncommon for people to experience other symptoms along with eye floaters. They may experience flashes of light that are not there, especially in the side of their fields of vision. They may also experience a loss of vision in the sides of their eyes.

Retinal detachment is serious and may lead to blindness without treatment. Anyone who notices a sudden and noticeable increase in floaters, along with other symptoms, should see an eye doctor immediately.

There are also more serious causes of floaters in the eye, including:

Anyone who notices a sudden increase in eye floaters should see an eye doctor to obtain a complete diagnosis.

The main symptoms of eye floaters are small areas in a persons field of vision that seem out of place.

Floaters can take different shapes, including:

They may also appear as a dark or lighter area of vision. Sometimes, the area where the floater is will look slightly blurry compared with the rest of the field of vision.

Floaters are tiny but can significantly affect the vision, as they are very close to the input of the eye.

One characteristic of eye floaters is that they seem to dart back and forth across the field of vision. Trying to look directly at a floater will cause it to move away in the direction the person looks.

When the person rests their eyes, the floaters seem to drift on their own.

Although it may not be possible to prevent eye floaters, it is still helpful to follow some basic practices to keep the eyes healthy. These include:

Eye floaters do not require treatment in most cases.

Although floaters may be irritating when a person notices them, they do not pose any direct threat to the sight.

In most cases, floaters settle down to the bottom of the eye, beneath the field of vision. The Columbia University Department of Ophthalmology estimate that it can take up to 3 months for a persons first floater to completely detach.

In rare circumstances, floaters may become very dense and potentially disrupt a persons vision. In these cases, a doctor may recommend a procedure called a vitrectomy.

During a vitrectomy, a healthcare professional will surgically remove the vitreous gel causing the floater. They will then replace this vitreous gel with a saline solution, or a bubble filled with gas or oil. Most people notice no difference between the vitreous and the saline solution after surgery.

Doctors generally reserve this procedure for serious circumstances, as it comes with its own set of potentially serious complications. These include cataracts and retinal detachment.

There are some alternatives to surgery for removing floaters.

A laser treatment method called laser vitreolysis may break apart or dissolve larger floaters, making them less noticeable. However, laser therapy is not for everyone.

An ophthalmologist will need to do a complete diagnosis in each case to see if the person could benefit from laser therapy.

Many people will experience eye floaters at one point or another. They can be annoying but are often harmless. Eventually, they may settle outside the field of vision, and most do not require treatment.

In very rare circumstances, eye floaters may disrupt vision and require surgical treatment. A sudden, very noticeable increase in eye floaters may also be a sign of other serious issues, such as retinal detachment, which could lead to blindness if a person does not receive prompt medical treatment.

Anyone who notices a sudden increase in eye floaters should visit an eye doctor for a full diagnosis.

Continued here:

Eye floaters: What causes them, and what can you do? - Medical News Today

Individual who provides a service related to the eyes or vision

An eye care professional (ECP) is an individual who provides a service related to the eyes or vision. It is any healthcare worker involved in eye care, from one with a small amount of post-secondary training to practitioners with a doctoral level of education.

Ophthalmologists are Doctors of Medicine (M.D./D.O.)(physicians) who specialize in eye care - this includes optical, medical and surgical eye care. They have a general medical degree, not a degree in eye care specifically.[1] In the US, this usually includes four years of college, four years of medical school, one year surgical internship and three years of eye specific training (ophthalmology residency). Some surgeons complete additional training (fellowship) in specific areas of the eye. Ophthalmologists are qualified to manage any eye disease, perform invasive eye surgery (including injections) and provide general medical care (non eye related) also.[2]

While Ophthalmologists can provide comprehensive care, typically they manage late state eye disease and perform surgery (specialty care). Their training is heavily focused on surgery.

An ophthalmic medical practitioner is a physician who specializes in ophthalmic conditions but who has not completed a specialization in ophthalmology. This title only relates to providers in Europe.

Optometrists are healthcare professionals with a degree in eye care, specifically. In the United States and Canada, they are Doctors of Optometry (O.D.) - this includes optical, medical and some surgical eye care. Their training typically includes four years of college followed by four years of eye specific training (Optometry school). Some complete an additional 5th year in a specialty area. Optometry school is a specialized program - specific to the eyes and related structures. Optometrists receive their medical eye training while in Optometry school and during internships (hospitals, private practices, universities, VA's etc.). Education is provided by professors, optometrists and physicians. Often, Optometry students and Ophthalmology residents will work together to co-manage medical cases. O.D.'s are trained and licensed to manage any eye disease (infections, glaucoma, macular degeneration, etc.) and practice medicine for eye related conditions - including topical medications (eye drops) or those taken by mouth including some schedule controlled substances. They may also order imaging tests (CT/MRI), remove ocular foreign bodies and perform some laser procedures. They are also qualified to perform some surgical procedures. Optometrists have the most optical training of any eye care professional and are the only eye care providers with a degree specific to eye care.

In the United States, Optometrists are considered physicians within their scope of practice and bill medical insurances according to Medicare.[3]

Outside of the United States and Canada, Optometrists typically do not hold a doctorate degree and may be limited in providing surgical treatments. However, some countries such as the UK, include a combination of providers where some Optometrists hold postgraduate doctorate degrees and some do not.

Orthoptists specialize in diagnosis and management of eye movement and coordination problems, misalignment of the visual axis, convergence and accommodation problems, and conditions such as amblyopia, strabismus, and binocular vision disorders, as outlined by the International Orthoptic Association.[4] They may assist ophthalmologists in surgery, teach orthoptic students, students of other allied health professions, medical students, and ophthalmology residents and fellows, act as vision researchers, perform vision screening, perform low vision assessments and act as clinical administrators.[5]

Ocularists specialize in the fabrication and fitting of ocular prostheses for people who have lost eyes due to trauma or illness.

Opticians specialize in the fitting and fabrication of ophthalmic lenses, spectacles, contact lenses, low vision aids and ocular prosthetics. They may also be referred to as an "optical dispenser", "dispensing optician", "ophthalmic dispenser". The prescription for the corrective lenses must be supplied by an ophthalmologist, optometrist or in some countries an orthoptist. This is a regulated profession in most jurisdictions.

A collective term for allied health personnel in ophthalmology. It is often used to refer to specialized personnel (unlike ocularists or opticians). In many countries these allied personnel may just be known as an "ophthalmic assistant". Their training is usually combined with a two or three year applied science degree and they assist an ophthalmologist or optometrist in the hospital or clinic with vision testing.

In the USA the Joint Commission on Allied Health Personnel in Ophthalmology administers OMP certifications:

Oculist is an older term that was primarily used to describe eye care professionals that are trained and specialized in the eye care field, specifically ophthalmologists and optometrists. The term is no longer used in the United States.

A vision therapist, usually either an orthoptist or optometrist, works with patients that require vision therapy, such as low vision patients. Commonly, vision therapy is performed in children who develop problems with their vision mostly because they are using their eyes up close. This type of therapy is however generally used in patients who need visual correction but for whom the corrective lenses are not enough to reverse the condition. Visual therapy in children is performed by optometrists who specialize in children's eye care. To specialize in vision therapy, doctors must complete extensive post-graduate training beyond their optometric degree, at which time they are eligible to sit for their national boards to become fully certified as specialists in children's vision. A doctor's title after passing the national board in vision therapy is Fellow in the College of Optometrists in Vision Development, or F.C.O.V.D. Optometrists who provide vision therapy but who have not yet sat for their certification exams are board-eligible Associates in the College of Optometrists in Vision Development.Vision therapists typically use prisms, eye patches, filtered lenses, and computerized systems to conduct therapy sessions.

Most eye care professionals do not practice iridology, citing a significant lack of scientific evidence for the practice.

Ophthalmologists generally provide specialty eye care and manage late stage eye disease (often only mitigated with surgery).

Optometrists typically provide comprehensive eye care - including medical, up to a moderate stage (managed with prescription medications). There is considerable overlap in scope of practice between professions. Optometrists are licensed to provide exactly the same medical care as ophthalmologists, but not invasive surgery.

Orthoptists specialize in the diagnosis and management of problems with eye movement and coordination, such as misalignment of the visual axis, binocular vision problems, and pre/post surgical care of strabismus patients. They do not directly treat ocular disease with medications or surgery. Orthoptists are trained to treat patients using optical aids and eye exercises[6][failed verification]. Orthoptists are primarily found working alongside ophthalmologists and optometrists to co-manage binocular vision treatment, visual field loss management and accommodative therapy. They often do standard eye and vision testing along with computerised axillary testing.

All three types of professional perform screenings for common ocular problems affecting children (such as amblyopia and strabismus) and adults (such as cataracts, glaucoma, and diabetic retinopathy).[7] All are required to participate in ongoing continuing education courses to maintain licensure and stay current on the latest standards of care.

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Eye care professional - Wikipedia

Alberta has become the first province in Canada to use new gene therapy to treat a rare and debilitating genetic eye disease.

The first three patients two young children and an adult received the treatment Dec. 14 at the Royal Alexandra Hospital in Edmonton.

The Royal Alex is the first of four places in Canada that will offer the gene therapy.

It will give people who previously have been relegated to seeing life getting increasingly blurred and eventually dark a brighter future, said Dr. Matthew Tennant, a clinical professor at the department of ophthalmology and visual science at the University of Alberta.

Tennant was one of the doctors who conducted the surgeries.

"All those people who now are relegated to continue to lose vision throughout their lives they will have hope and they will have the possibility of stability," he said.

"The next generation of people with retinitis pigmentosa will have treatment when they're born, or early in their lives, so that their vision will be normal. They'll never have deterioration."

The gene therapy involves a drug called Luxturna, developed by the American biotech company Spark Therapeutics.

Luxturna treats an aggressive form of retinitis pigmentosa, a group of diseases caused by some 300 gene mutations that all involve the retina and cause progressive decline and loss of vision.

The type of retinitis pigmentosa treated by Luxturna is caused by a faulty gene called RPE65.

When the gene malfunctions, photoreceptors stop working over time.

Photoreceptors are the cells in the retina that convert light into electrical signals that get sent to the brain, which allows people to see.

Photoreceptors are kept alive by an underlying layer of cells called retinal pigment epithelium. When the RPE65 gene doesn't work properly,the cells in the retinal pigment epithelium and photoreceptors don't work correctly.

Photoreceptors don't get enough nutrition and can't process and eventually they die.

Luxturna helps replace the malfunctioning gene with a normal one.

"It involves delivery of a healthy copy of a gene like RPE65 into the retinas," said Shannon Boye, a professor and associate chief of the division of cellular and molecular therapy at the University of Florida.

"Once inside the retina, that healthy gene will go on to make a healthy protein that can then go on to interact properly with all of the other proteins in the retina and ultimately restore the patient's ability to process light into an electrochemical signal" and see normally, she said.

The healthy gene is delivered into the cell using a modified virus. Scientists have managed to rip the original DNA out of a virus and replace it with the healthy gene.

When the virus makes its way into the cell, the faulty gene is switched off. The cell begins to function normally and photoreceptors receive enough nutrients.

"There is some ability to save damaged cells that have not died, but we are not able to fix all that have already gone. It doesn't replace dead cells, so that means that early treatment is the way for maximum success," Tennant said.

The treatment is performed by injecting the modified therapeutic viruses between the retina and the retinal pigment epithelium. This requires significant surgical skills the space between the two is only two or three microns. There, the viruses are injected into the fluid pocket.

Gene therapy is expensive. It costs $1 million to treat both eyes with Luxturna. However, it is a one-time procedure, and the fix is permanent.

The disease that this gene therapy treats is extremely rare. There are probably just 300 people in Canada who have it, said Dr. Ian MacDonald, an ophthalmologist and AHS Edmonton Zone clinical chief of ophthalmology.

"We would estimate that we would treat one new Albertan every year," said MacDonald, who noted that patients from across Western Canada will be treated at the Royal Alex.

There is no waiting period for Albertans to receive Luxturna and there are no out-of-pocket expenses, said Charity Wallace, assistant director for communications at Alberta Health, in an email.

Using gene therapy to treat hereditary eye disease has shown the medical and commercial viability of gene therapies, Boye said.

"I think that every one of these therapies that gets approved is going to bring our regulatory agencies to a point where they're more and more comfortable with this type of medicine becoming mainstream."

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New gene therapy to treat rare eye disease now available in Alberta ...

HEIDELBERG, Germany, and CAMBRIDGE, MA, Aug. 9, 2022 /PRNewswire/ -- Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol water-free technology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for CyclASol (cyclosporine ophthalmic solution), a proposed novel treatment for the signs and symptoms of dry eye disease (DED).

CyclASol has demonstrated in two pivotal studies fast onset of therapeutic effect in the indication, clinical meaningful improvement of ocular surface damage, and excellent tolerability. Results from a 12-month long-term study confirmed that the effects are maintained, and even improved for most sign and symptom endpoints.

"This is the first submission of a novel product category of water-free topical drug therapies utilizing EyeSol as a drug carrier", said Christian Roesky, Ph.D., CEO, Novaliq. "CyclASol is a first-of-a-kind drug therapy and aims to expand treatment success for patients with dry eye disease and their eye care professionals. If approved by the FDA, CyclASol addresses important unmet medical needs in DED through its ocular surface healing effect combined with high comfort of administration."

Dry eye is one of the most common ocular surface disorders, with approximately 18 million Americans diagnosed with DED.1,2 Inflammation and immunologic processes play a key role in the pathology of the disease.

A compromised ocular surface secondary to DED may also compromise refractive measurements before keratorefractive and phacorefractive surgeries and adversely impact expected visual outcomes after these surgeries.3,4 The impact of the corneal surface damage secondary to DED on visual function is an underestimated aspect of the disease. Multiple guidelines recommend treatment of the corneal surface damage prior to ocular procedures. A high unmet need remains for better tolerated drugs with an early onset of therapeutic effect, which are compelling to be used and prescribed.5,6

"We are very proud to see another product rapidly moving to the market, which marks yet another important inflection point and milestone in Novaliq's growth trajectory", said Dr. Mathias Hothum, board member and managing director of dievini. "We are currently evaluating the commercialization strategies which includes talking to interested parties."

About CyclASol CyclASol is a first-of-a-kind topical treatment of cyclosporine, a potent anti-inflammatory and selective immunomodulatory drug. Whilst not water-soluble, cyclosporine is soluble in the EyeSol excipient perfluorobutylpentane allowing for its improved bioavailability and better efficacy on the target tissue. The product contains no oils, no surfactants and is preservative-free due to the novel carrier. This provides additional clinical benefits for patients, such as improved tolerability and decreased visual disturbances.

The NDA is supported by safety and efficacy results in over 1,000 patients with DED from a Phase 2 dose finding study, the Phase 2b/3 ESSENCE-1 study, the Phase 3 ESSENCE-2 study and its open label extension study.7,8

CyclASol has demonstrated in two independent adequate and well-controlled, multicenter studies (ESSENCE-1 and ESSENCE-2) clinically meaningful and statistically significant improvements in the indication.

Effects on the ocular surfaceinclude a statistically significant reduction in total corneal fluorescein staining (tCFS) score favoring CyclASol in both studies at Days 15 and 29. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement of 3 grades in total corneal staining. This proportion of responders was significantly higher compared to vehicle-treated patients in both studies. Responders showed also statistically significant improvements in a variety of symptoms compared to non-responders at day 29. The ASCRS guidelines recognize corneal staining as the single most important clinical sign of DED as it indicates the level of epithelial damage and visual impairment, and if left undertreated, DED can become chronic and more difficult to treat.3

Effect on tear production: In both studies, compared to vehicle at the end of treatment, there was a statistically significant (p<0.05) higher percentage of patientswith increases of 10 mm from baseline in Schirmer's tear test score at Day 85 and Day 29, respectively, confirming a known effect of the active ingredient cyclosporine. Meeting this endpoint in two independent studies is clinically meaningful on its own and considered to demonstrate efficacy for the treatment of signs and symptoms of DED.

Head-to-head dataversus Restasisfrom the phase 2 study suggest that CyclASol has a stronger and faster therapeutic effect on the ocular surface.8

Maintenance of effectresults from the long-term study CYS-005 confirmed that the effect of CyclASol was maintained, and even improved for most endpoints, over the 52-week treatment period.

Safety and Tolerability: Tolerability of CyclASol was shown by high drop comfort patient ratings in both studies. The most common adverse reaction observed was instillation site reactions, which was reported in 8.1% of patients in the pooled studies. These were in all but one case mild. The only other adverse reaction reported in > 2% of the patients was visual acuity reduced (2.7%).

About NovaliqNovaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol, the worldwide first water-free technology.

EyeSol is Novaliq's proprietary water-free technology using ultrapure semifluorinated alkanes (SFAs) that are physically, chemically, and physiologically inert with excellent biocompatibility and a very good safety profile. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases.

In July 2022 submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) was announced seeking approval for NOV03 (perfluorohexyloctane), for the proposed indication of treating the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). In addition to CyclASol, the company continues to progress multiple additional pipeline opportunities based on its validated EyeSol platform, both in ophthalmology and adjacent indications like dermatology.

Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on http://www.novaliq.com.

Recommended Readings

Any product/brand names and/or logos are trademarks of the respective owners. 2022 Novaliq GmbH, Heidelberg, Germany.

Novaliq Media Contact: Simone Angstmann-Mehr[emailprotected]+49 6221 50259-0

Logo: https://mma.prnewswire.com/media/1804666/Novaliq_GmbH_Logo.jpg

SOURCE Novaliq GmbH

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Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol - PR Newswire

When coronary arteries are blocked, starving the heart of blood, there are good medications and treatments to deploy, from statins to stents. Not so for heart failure, the leading factor involved in heart disease, the top cause of death worldwide.

Its whats on death certificates, said cardiologist Christine Seidman.

Seidman has long been interested in heart muscle disorders and their genetic drivers. She studies heart failure and other conditions that affect the myocardium the muscular tissue of the heart not the blood vessels where atherosclerosis and heart attacks come from, although their consequences are also felt in the myocardium, including heart failure.

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With her colleagues at Brigham and Womens Hospital and Harvard Medical School, she and a long list of international collaborators have been exploring the genetic underpinnings of heart failure. Based on experiments deploying a new technique called single-nucleus RNA sequencing on samples from heart patients, on Thursday they reported in Science their discovery of how genotypes change the way the heart functions.

Their work raises the possibility that some of the molecular pathways that lead to heart failure could be precisely targeted, in contrast to treating heart failure as a disease with only one final outcome.

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Were not there yet, but we certainly have the capacity to make small molecules to interfere with pathways that we think are deleterious to the heart in this setting, she said. To my mind, thats the way to drive precision therapeutics. We know the cause of heart failure. We intervene in a pathway that we know is activated. And for the first time, we have that information now from human samples, not from an experimental model.

Seidman talked with STAT about the research, including how snRNAseq solves the smoothie problem, and what it might mean for patients. The conversation has been edited for clarity and brevity.

What happens in heart failure?

The heart becomes misshapen in one of two ways. It either becomes hypertrophied, where the walls of heart muscle become thickened and the volume within the heart is diminished, in what we call hypertrophic cardiomyopathy. Or it becomes dilated, when the volume in the heart is expanded and the walls become stretched. I think of it as an overinflated balloon, and that is called dilated cardiomyopathy.

Hypertrophy and dilatation are known to cause the heart over time to have profoundly diminished functional capacity. And clinically, we call that heart failure, much more commonly arising from dilated cardiomyopathy.

What does it feel like to patients?

When we see patients clinically, theyre short of breath, they have fluid retention. When we look at their hearts, we see that the pump function is diminished. That has led to a hypothesis of heart failure as sort of the end stage of many different disorders, but eventually the heart walks down a final common pathway. Then you need a transplant or a left ventricular assist device, or youre going to die prematurely.

What can be done?

Heart failure is a truly devastating condition, and it can arise early in life, in middle age, and in older people. There is no treatment for it, no cure for it, except cardiac transplantation, of course, which provides a whole host of other problems.

How did you approach this problem?

One of the questions we wanted to answer is, are there signals that we can discern that say there are different pathways and there are molecules that are functioning in those pathways that ultimately converge for failure, but through different strategies of your heart?

We treat every patient with heart failure with diuretics. We give them a series of different medications to reduce the pressure against which the heart has to contract. Im clinically a cardiologist, but molecularly Im a geneticist, so it doesnt make sense. If your house is falling down because the bricks are sticking together or if its falling down because the roof leaks and the water is pooling, you do things differently.

Tell me how you used single-cell RNA sequencing to learn more.

Looking at RNA molecules gives us a snapshot of how much a gene is active or inactive at a particular time point. Until recently, we couldnt do that in the heart because the approach had been to take heart tissue, grind it all up, and look at the RNAs that are up or down. But that gives you what we call a smoothie: Its all the different component cells those strawberries, blueberries, bananas mixed together.

But theres a technology now called single-cell RNA sequencing. And that says, what are the RNAs that are up or down in the cardiomyocytes as compared to the smooth muscle cells, as compared to the fibroblasts, all of which are in the cells? You get a much more precise look at whats changing in a different cell type. And thats the approach that we use, because cardiomyocytes [the cells in the heart that make it contract] are very large. Theyre at least three times bigger than other cells. We cant capture the single cell it literally does not fit through the microfluidic device. And so we sequenced the nuclei, which is where the RNA emanates from.

What did you find?

There were some similarities, but what was remarkable was the degree of differences that we saw in cardiomyocytes, in endothelial cells, in fibroblasts. Theres a signature thats telling us I walked down this pathway as compared to a different one that caused the heart to fail, but through activation or lack of activation of different signals along the way.

And that to me is the excitement, because if we can say that, we can then go back and say, OK, what happens if we were to have tweaked the pathway in this genotype and a different pathway in a different genotype? Thats really what precision therapy could be about, and thats where we aim to get to.

Whats the next step?

It may be that several genotypes will have more similarities as compared to other genotypes. But understanding that, I think, will allow us to test in experimental models, largely in mice, but increasingly in cellular models of disease, in iPS [induced pluripotent stem] cells that we can now begin to use molecular technologies to silence a pathway and see what that does to the cardiomyocytes, or silence the fibroblast molecule and see what that does in that particular genotype.

To my mind, thats the way to drive precision therapeutics. We know the cause of heart failure. We intervene in a pathway that we know is activated. And for the first time, we have that information now from human samples, not from an experimental model.

What might this mean for patients?

If we knew that an intervention would make a difference thats where the experiments are we would intervene when we saw manifestations of disease. So the reason I can tell you with confidence that certain genes cause dilated cardiomyopathy is theres a long time between the onset of that expansion of the ventricle until you develop heart failure. So theres years for us to be able to stop it in its tracks or potentially revert the pathology, if we can do that.

What else can you say?

I would be foolish not to mention the genetic cause of dilated cardiomyopathy. Ultimately, if you know the genetic cause of dilated cardiomyopathy, this is where gene therapy may be the ultimate cure. Were not there yet, but we certainly have the capacity to make small molecules to interfere with pathways that we think are deleterious to the heart in this setting.

My colleagues have estimated that approximately 1 in 250 to 1 in 500 people may have an important genetic driver of heart muscle disease, cardiomyopathy. Thats a huge number, but not all of them will progress to heart failure, thank goodness. Around the world, there are 23 million people with heart failure. Its what ends up on most peoples death certificate. It is the most common cause of death.

Its a huge, huge burden. And there really is no cure for it except transplantation. We dont have a reparative capacity, so were going to have to know a cause and be able to intervene precisely for that cause.

Read more:

New research digs into the genetic drivers of heart failure, with an eye to precision treatments - STAT

Wilmington, Delaware, United States, Transparency Market Research Inc. The healthcare category research depicts a clear overview of various inter-connected factors that can influence the development of global gamma probe device market in coming years. Players and manufacturers in the global gamma probe device market are focused on developing new products that feature advanced gamma probe technologies in their product offerings.

For example, Dilon technologies, Inc. launched a new product in 2016 called the Dilon navigator 2.0. This product is expected to assist in the sentinel lymph node biopsy. Launches like these are expected to foster the development in global gamma probe device market in near future.

The professional intelligence study provides a holistic account of numerous shifts brought on by the novel corona virus pandemic in the global gamma probe device market. It also offers valuable information pertaining to several crucial industry segments and presents a complete and comprehensive analysis of the key consumer segments in the global gamma probe device market.

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The healthcare survey report sheds light on various important trends as well as latest developments that can positively affect the global gamma probe device market over the forecast years i.e. 2021 to 2031. It also presents important information regarding the regional, geographical, and the competitive landscape of the global gamma probe device market over the forecast period.

Global Gamma Probe Device Market: Major Trends and Drivers

Rising cases of cancer, especially breast cancer is one of the major and foremost driving factors for the global gamma probe device market. For example, as per a 2018 report by the World Cancer Research Fund, there were approximately 2 million new instances of breast cancer cases that were promoted for the surgical procedure. Products in the global gamma probe device market are used for both diagnostic as well as therapeutic purposes. Rising utilization of mobile gamma probes for both sentinel lymph node snapping for diagnostics as well as treatment for parathyroid surgical treatment is expected to create new opportunities for the global gamma probe device market.

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Moreover, rising preference of radio guided surgeries using products from the global gamma probe device market owing to their minimally invasive operating nature may also boost the demand in industry in near future. On the other hand, high cost associated with acquirement of products in the global gamma probe device market may hamper the growth trajectory of the industry in coming years.

Global Gamma Probe Device Market: Key Players and Manufacturers

Some of the most prominent and leading players functioning within the global gamma probe device market include Lake Shore Cryotronics Inc., Wake Medical, Thermo Fisher Scientific, Tron Medical Ltd., Hologic Inc., Raditec Medical AG, Dilon Technologies, Inc., as well as the Intramedica Imaging, among others. Various leading and established players in the global gamma probe device market are engaged in new product launches as well as product innovations in a bid to attract more consumers. Players are also focused on discovering ways to expand their grographical reach in order to expand their consumer base across the world.

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Global Gamma Probe Device Market: Regional Assessment

Regionally, North America is anticipated to lead the global gamma probe device market in terms of demand. Key factors that may motivate sales in the global gamma probe device market in North America include rising number of patients suffering from cancer, new product launches, technological advancements, and rising usage of nuclear medicine.

Furthermore, increasing investment in research and development, coupled with government funding for usage of medical isotopes in the region have also led to dramatic increase in the demand in global gamma probe device market. Moreover, presence of well-trenched healthcare players and infrastructure as well as rising regional expenditure on healthcare is fuelling the development of global gamma probe device market.

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Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyze information.

Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports.

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Gamma Probe Device Market Trends, On-going Demand, Opportunities, Segmentation, and Forecast till 2031 - BioSpace

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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Medical Holography Market: The global medical holography market was valued at around US$ 240.0 Mn in 2017 and is anticipated to reach around US$ 3500.0 Mn by 2026.

About Us

Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyze information.

Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports.

For More Research Insights on Leading Industries, Visit Our YouTube Channel and hit subscribe for Future Update - https://www.youtube.com/channel/UC8e-z-g23-TdDMuODiL8BKQ

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Rohit BhiseyTransparency Market Research Inc.CORPORATE HEADQUARTER DOWNTOWN,1000 N. West Street,Suite 1200, Wilmington, Delaware 19801 USATel: +1-518-618-1030USA Canada Toll Free: 866-552-3453Website: https://www.transparencymarketresearch.comBlog: https://tmrblog.comEmail: sales@transparencymarketresearch.com

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

People with extreme nearsightedness, or myopia, may experience myopic macular degeneration (MMD). This condition can lead to a gradual decrease in central vision.

In people with myopia, the distance between the front and back of each eye is greater than average. This increased eyeball size makes it harder to focus on objects in the distance. Some people with this condition may be at greater risk of developing other eye conditions.

This article will review all there is to know about MMD, from signs and symptoms to the latest research.

MMD, also called degenerative myopia, is the leading cause of legal blindness.

The macula is a tiny region located in the center of the retina. When the retina stretches in people with myopia, it can cause the cells in the macula to degenerate.

If damage occurs to cells in the macula, individuals may experience a blind spot in their central vision. The resulting condition is called MMD.

The causes of MMD vary between individuals.

Excessive stretching can change the arrangement of photoreceptors within the eye. This can impact vision even before degeneration begins.

Changes in certain proteins can also occur as a result of eyeball elongation. Atypical collagen proteins, for example, can lead to a weaker eye structure and cause retinal degeneration.

Additionally, researchers believe that inflammatory conditions may contribute to MMD. Chronic inflammation in the eye tissue may further alter eye structure and function.

Although research links macular degeneration and myopia, not all people with myopia will experience macular degeneration.

During the early stages of MMD, people may experience few, if any, symptoms. A blurry spot in the central vision may eventually appear and worsen with time.

Other common symptoms may include:

People who experience unexpected vision changes should consult an eye specialist.

Changes in central vision, gray or blurry spots, or having trouble reading and recognizing people may all indicate MMD.

A specialist will perform a thorough exam and diagnostic tests to determine whether a persons symptoms indicate MMD. They can then discuss the individuals outlook and treatment options.

People with MMD may experience complications. For example, damage to the retina or scarring in the macula tissue may occur. MMD can lead to blindness in severe cases.

Individuals who receive a diagnosis of MMD should consult with a doctor to prevent any potential complications.

Each case of MMD is unique, and only a medical professional can provide an accurate assessment.

Older individuals and people with very severe myopia have a higher chance of developing MMD.

Research from 2022 suggests that genetics and a persons environment can play a role in the development and severity of myopia. A family history of myopia increases an individuals risk of nearsightedness. A person can also inherit changes to genes involved in eyesight.

Additionally, research indicates that spending more time outdoors helps prevent myopia and that modern, urban lifestyles may put individuals at risk of developing myopia and MMD.

There is currently no single cure for MMD. However, several different treatment options may help prevent vision loss among those who develop this condition.

People with MMD usually develop new blood vessels under the retina. These blood vessels can leak and worsen the effects of MMD. One of the most common treatments involves anti-vascular endothelial growth factor (anti-VEGF) injections. Anti-VEGF drugs may reduce new blood vessel growth, improve vision, and slow macular thickening.

Research also indicates that photodynamic therapy may help treat MMD. Read more about laser therapy for macular degeneration here.

A possible surgical procedure is posterior scleral reinforcement (PSR). The main objective of PSR is to slow down axial elongation, which occurs with myopia.

No one treatment protocol is right for everyone. Individuals with MMD should speak with a medical professional to explore the best treatment options for their unique case.

Managing myopia early in life can help reduce the risk of developing MMD. Possible ways to do this include avoiding exposure to screens and emphasizing time spent outdoors.

Other treatments, such as atropine eye drops, can also help decrease myopia progression in children.

In mild cases of myopia, eyeglasses or contact lenses can improve eyesight. People with more severe myopia may elect to have surgery.

Consistent, thorough eye exams can help detect vision changes early. Eye specialists recommend people with severe myopia and MMD have eye exams every year or more frequently if needed.

During an eye exam, a specialist can ensure that the eyes function correctly. They can also monitor any vision changes that develop gradually.

Individuals with severe myopia may be at greater risk for MMD. This condition can lead to vision changes or, in extreme cases, blindness.

Managing myopia early in life can help reduce the risk of developing MMD. Routine eye examinations with a specialist can also help detect vision problems in their earliest stages.

People who experience myopia should work with a medical professional to manage and monitor their condition over time. Consistent medical support can help manage myopia and reduce the long-term effects of MMD.

Read the rest here:

Myopic macular degeneration: What it is, and more - Medical News Today

Courtesy of Smith Collection Gado/Getty Images

Roche has had a good week, sharing positive two-year data from Genentech's study on Vabysmo for age-related macular degeneration and eight-year data in its trial for combination therapy for HER2-positive early breast cancer.

2-Year Data On Vabysmo Demonstrates Reliability & Safety

Genentech, a part of the Roche Group, shared positive two years' worth of data from its ongoing LUCERNE and TENAYA trials, which are looking into Vabysmo's (faricimab-svoa) long-term safety, efficacy and durability in wet or neovascular AMD.

In both the TENAYA and LUCERNE studies, over 60% of the participants were able to be treated every four months, up 15% from where they were in the first year. Almost 80% were able to treat at least every three months. No new safety signals came up, and the drug continued to be well tolerated and demonstrate a favorable risk profile.

"These longer-term results reinforce confidence in Vabysmo and support its continued use in people with wet AMD. With the potential to require fewer injections over time, Vabysmo continues to represent an important step forward for people with vision-threatening retinal conditions, and these data exemplify our commitment to redefining standards of care and reducing treatment burden," Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development at Genentech, said in a statement.

The disorder, a leading cause of vision loss, affects around 1.1 million people in the United States alone. Treatment usually involves eye injections administered every one or two months. Vabysmo is evaluated for its potential to reduce the frequency of injections.

Vabysmo is the first bispecific antibody for the eye and the only injectable eye medicine approved by the U.S. Food and Drug Administration. It is currently under review by the European Medicines Agency and other regulatory agencies worldwide.

Combination Breast Cancer Therapy Delivers Positive 8-Year Data

Meanwhile, Roche announced positive eight-year data from its long-term evaluation of Perjeta (pertuzumab) combined with Herceptin (trastuzumab) and chemotherapy (Perjeta-based) in HER2-positive early breast cancer, versus Herceptin, chemotherapy and a placebo.

Results at 8.4 years, with a median follow-up of 101 months, showed that patients with lymph node-positive disease saw a 28% reduction in the risk of recurrence or death. The combination's safety profile also remained consistent with previous trials. There were fewer deaths at 168 versus 202 in the placebo group, and around 88.4% of those who received the treatment post-surgery had remained disease-free compared to the 85.8% of the placebo takers.

"The eight-year APHINITY results show the great progress made in treating this aggressive form of early breast cancer. HER2-positive breast cancers are more likely than other subtypes to recur following surgery, so targeted treatment is critical to provide the best chance for a cure," Garraway said, who is also Roches chief medical officer and head of global product development.

Details were presented at the European Society for Medical Oncology (ESMO) Virtual Plenary.

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Roche Wraps Week with a Bang, Touting Long-Term Breast Cancer, AMD Data - BioSpace

Data reinforces strong safety and efficacy for EYP-1901 as a potential six-month maintenance treatment for previously treated wet AMD

No dose limiting toxicities, no ocular serious adverse events (SAEs) and no drug-related systemic SAEs observed

Stable visual acuity and optical coherence tomography observed from a single treatment

Phase 2 clinical trial (DAVIO2) in wet AMD patient dosing anticipated in Q3 2022

WATERTOWN, Mass., July 15, 2022 /PRNewswire/ -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced 12-month data from the Phase 1 "Durasert and Vorolanib in Ophthalmology" (DAVIO) clinical trial evaluating EYP-1901, a sustained delivery anti-vascular endothelial growth factor (anti-VEGF) therapy targeting wet age-related macular degeneration (wet AMD) as a potential every six-month treatment. These data are being presented today at the American Society of Retina Specialists (ASRS) 2022 Annual Meeting by Rishi Singh, M.D., Staff Physician, Cleveland Clinic Florida, President Cleveland Clinic Martin Hospitals.

EyePoint Pharmaceuticals, Inc. logo

"The final 12-month results from the DAVIO clinical trial highlight EYP-1901's continued positive safety and efficacy profile with promising durability as a potential every six-month maintenance therapy for previously treated wet AMD," said Rishi Singh, M.D., a member of EyePoint's Scientific Advisory Board. "We are grateful to the patients, investigators and site staff who participated in the Phase 1 DAVIO trial."

"We are extremely pleased with the excellent safety and efficacy results from our Phase 1 DAVIO trial. There remains a significant opportunity for a safe and effective sustained delivery maintenance treatment in wet AMD, and the DAVIO trial demonstrates that EYP-1901 has the potential to maintain a majority of patients for up to six months with no supplemental anti-VEGF therapy," saidNancy Lurker, Chief Executive Officer ofEyePoint Pharmaceuticals. "We look forward to beginning to dose patients in the Phase 2 DAVIO2 clinical trial for EYP-1901 in wet AMD and anticipate top line data in the second half of 2023."

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The final twelve-month data presented from the Phase 1 DAVIO clinical trial showed no reports of ocular SAEs or drug-related systemic SAEs. There were no reported events of vitreous floaters, endophthalmitis, retinal detachment, implant migration in the anterior chamber, retinal vasculitis, posterior segment inflammation, or retinal vascular occlusive events. Additionally, updated data from the twelve-month follow-up confirm stable best corrected visual acuity (BCVA) (-4.12 ETDRS letters), stable central subfield thickness (CST) on optical coherence tomography (OCT) (-2.76 m), and an expected late increase in supplemental anti-VEGF therapy given the insert's expected drug depletion, with 35% of eyes supplement free up to twelve months versus 53% supplement free up to six months. Additionally, there continued to be positive treatment burden reduction of 74% at twelve months versus 79% at six-months.

EyePoint anticipates that the first patient in the twelve-month, randomized, controlled Phase 2 clinical trial (DAVIO2) of EYP-1901 for wet AMD will be dosed in Q3 2022. The trial is expected to enroll approximately 150 wet AMD patients previously treated with a standard-of-care anti-VEGF therapy and randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) versus an on-label aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO2 trial is non-inferiority to the aflibercept control, as measured by change in BCVA six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in CST as measured by OCT, time to first supplemental anti-VEGF, and safety. More information about the study is available at clinicaltrials.gov (identifier: NCT05381948).

About EYP-1901

EYP-1901 is being developed as an investigational sustained delivery treatment, initially in wet age-related macular degeneration (wet AMD)combining a bioerodible formulation of EyePoint's proprietary Durasert delivery technology with vorolanib, a tyrosine kinase inhibitor. Positive twelve-month safety and efficacy data from the Phase 1 DAVIO clinical trial of EYP-1901 showed no reports of ocular or drug-related systemic serious adverse eventsand no dose limiting toxicities with stable visual acuity and OCT. Further, 53% of eyes did not require supplemental anti-VEGF injections up to six months following a single dose of EYP-1901. A Phase 2 trial for wet AMD (DAVIO2) is expected in Q3 2022 and Phase 2 studies are planned for non-proliferative diabetic retinopathy and diabetic macular edema in 2H 2022 and 2023, respectively. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.

About Wet AMD

Age-related macular degeneration (AMD) impacts as many as 11 million Americans. About 15% of those affected have neovascular or wet AMD - the hallmark of which is fluid and bleeding in the center of the retina, which may lead to irreversible vision loss. The majority of patients with wet AMD require intravitreal injections every month or two to control the disease. This intense treatment regimen represents an ongoing challenge for patients, caregivers, and physicians.

About EyePoint Pharmaceuticals

EyePoint Pharmaceuticals (Nasdaq: EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. The proven Durasert drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products, including YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, which is currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.

Forward Looking Statements

EYEPOINT PHARMACEUTICALS SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint's actual results to be materially different than those expressed in or implied by EyePoint's forward-looking statements. For EyePoint, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a sustained delivery intravitreal anti-VEGF treatment for serious eye diseases, including wet age-related macular degeneration; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition and other developments affecting sales of our commercialized products, YUTIQ and DEXYCU; market acceptance of our products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; the continued impact of the COVID-19 pandemic on EyePoint's business, the medical community and the global economy; and the impact of general business and economic conditions. More detailed information on these and additional factors that could affect EyePoint's actual results are described in EyePoint's filings with theSEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. All forward-looking statements in this news release speak only as of the date of this news release. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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Christina TartagliaStern IRDirect: 212-698-8700christina.tartaglia@sternir.com

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EyePoint Pharmaceuticals Announces Positive 12-Month Safety and Efficacy Data from Phase 1 DAVIO Clinical Trial Evaluating EYP-1901 for the Treatment...

Do you see small mosquitoes and flies in front of your eyes, but you cannot drive them away no matter how you try? This is commonly known as eye floater syndrome or eye floaters and also known as muscae volitantes. Especially when looking at a white wall or the blue sky, floaters, which are dark shadows, are quite obvious. Some of these shadows are not shaped like bugs, but rather spots, filaments, and rings. In severe cases, the condition will affect the vision, causing inconvenience in daily life. In some cases, eye floaters may be a sign of serious eye disease.

What are the symptoms of eye floaters, and under what circumstances is there risk of blindness? What are the causes of eye floaters and treatments? We will explain below with infographics.

Eye floaters usually appear as follows:

Eye floaters have subjective symptoms, and the condition is closely associated with the vitreous humor in the eye. In medical terms, it is also known as vitreous clouding or vitreous degeneration.

What is vitreous humor (aka. vitreous body)?

It is a colorless, transparent colloid inside the eye, covered with a vitreous membrane. It is located between the lens and the retina and fills four-fifths of the eye, and its role is to support the retina, so that it can fittingly line the back wall of the eye.

The formation of eye floaters is generally due to the natural aging process of the vitreous humor, which liquefies and condenses, thus producing some cellular debris and adhesives. When these floating impurities in the vitreous humor are projected on the retina by light, the patient will see insects that cannot be driven away.

Most eye floaters are physiological and develop after the age of 40 due to the natural aging of the eyeball.

However, some can also be caused by eye diseases. Trauma to the eye, intraocular inflammation, retinal detachment, and vitreous hemorrhage are all pathological causes of muscae volitantes.

In ancient times, Chinese medicine practitioners called eye floaters fluttering and drifting cloud-like dark shadows or dark flowers and fly wings.

According to traditional Chinese medicine, the causes of the eye floater syndrome are related to the visceral disorders of the body, mainly damp turbidity, liver-kidney deficiency, and the deficiency of qi and blood. This can still be observed today, as many of the other symptoms of these deficiencies may accompany the appearance of floaters.

Damp turbidity: When the bodys dampness becomes too heavy, infringing on the vitreous humor in the eyes, the patient may also experience dizziness, chest congestion, poor digestion, and other symptoms. If you observe the patients tongue, you may see the phenomenon of thick and greasy tongue coating.

Liver-kidney deficiency: The deficiency of essence and blood in the liver and kidney will impede the supplying of nutrients to the eyes, thus causing cloudiness in the vitreous humor. Such patients may also experience tinnitus and back pain.

Qi and blood deficiency: Due to prolonged illness or blood loss, qi and blood deficiency may occur, and as the eyeballs cannot get sufficient nourishment from the blood, eye floaters may form. The patient may also experience dry eyes and photophobia. These patients are prone to having a pallid complexion and experiencing dizziness and palpitations.

Traditional Chinese medicine has a well-known prescription for eye treatment called water honeyed pill (lycii and chrysanthemi and rehmanniae bolus), which can also improve eye floater symptoms.

It includes rehmanniae, which can nourish the liver and kidneys, and goji berries and chrysanthemums, which can help improve eyesight. However, it is not suitable for patients with a cold or flu. If a patient has chronic diseases, such as high blood pressure, heart diseases, liver diseases, and diabetes, the medication should be taken under the instruction of a doctor.

When many patients first discover that they have eye floaters, they are particularly worried, fearing it is a symptom of a major or looming problem. In fact, eye floaters formed due to age are a normal phenomenon, and these people dont need to worry much.

However, the following conditions can cause serious eye floater syndrome, and even have the risk of blindness, so we must pay special attention to them:

Retinal detachment: The vitreous humor supports the retina at the back of the eyeball and is attached to the retina. If the vitreous liquefaction is too severe, the vitreous humor will gradually separate from the retina. And in the separation process, retinal tears and breaks develop when the vitreous pulls on the retina; if the liquefied vitreous humor pours in through the holes, it will cause retinal detachment.

When the vitreous humor pulls on the retina, flashes will appear in the vision; if the vitreous humor and retina are detached, flashes may occur frequently. If the retinal blood vessels are torn, blood will enter the vitreous body and form a black fog of flies that blocks the vision.

Vitreous hemorrhage: The vitreous body itself has no blood vessels, but if its surrounding tissues bleed, the blood will flow into it, which can lead to eye floaters. For instance, bleeding can be caused by uveitis, optic nerve papillitis, tumors, and blows to the eye.

People with high myopia, previous eye trauma, and diabetes are more likely to have retinal detachment and vitreous hemorrhage, and they should be more alert than the general population.

If the following four signs appear, it may mean theres a serious problem such as retinal detachment, and you should seek medical attention as soon as possible:

We can check for eye floaters by ourselves at home. Just cover one eye and stare at a white wall with the other eye to see if any floaters can be spotted.

After you find floating objects in front of your eyes for the first time, you can see an ophthalmologist for a fundus examination. If it is confirmed to be a physiological form of floaters, then there is no need to worry too much, just keep observing the symptoms and follow up with the ophthalmologist regularly.

It is also very convenient to go to a hospital or clinic to check for eye floaters. The procedure is to dilate the pupils with some eye drops (dilating agent) first, wait for about half an hour, and then perform a fundus examination. It should be noted that the dilating agent will cause temporary blurred vision and photophobia, so it is recommended to wear sunglasses after the examination. In addition, it is best to have a family member or friend accompany you after the examination, as you should not drive with dilated pupils.

Eye floaters caused by vitreous degeneration alone will not go away, and there is no specific medicine to treat the condition. Therefore, it is not recommended to treat floaters if they only pose a general nuisance. When the dark shadows affect your vision, you can try to rotate your eyeballs, so that the floating objects in the vitreous bodies will leave the center of your vision.

In a small number of cases, the eye floaters are so dense that they seriously affect the vision. For such patients, there are two treatment options to consider:

Surgically, the vitreous fluid and floaters can be removed from the eye, and the old vitreous fluid is replaced with a salt solution. Since vitreous humor is mainly aqueous, there is no significant difference after the replacement. However, this procedure carries a high risk of complications, such as retinal detachment, retinal tears, and cataracts.

Laser therapy uses lasers to target the floating objects in the vitreous humor to break them down and shatter them, so as to improve the symptoms of eye floaters. However, this method is rarely used, as its effect varies from person to person. If theres an error when aiming the lasers, it may damage the retina.

If the condition of the patients eyes is relatively severe, such as having a fissure in the peripheral retina, a retinal laser surgery can be used to utilize the lasers coagulation effect to fix the retina around the fissure to the wall of the eyeball to prevent further deterioration into retinal detachment. If it is a vitreous hemorrhage, the patient can take hemostatic medication for about 3 to 6 months to allow the oozed blood to be absorbed gradually, and then undergo more complicated treatments, if the condition hasnt improved by then.

The first and foremost task in caring for eyes with floaters is to slow down the aging of the vitreous humor. Therefore, an eye floater patient should avoid staying up late and using electronic devices, such as cell phones and tablets, excessively, and should use desk lamps with soft light.

In addition, we should avoid strenuous and rapid head-turning exercises, such as bungee jumping and riding roller coasters, and excessive eyeball movements.

Furthermore, we can also take appropriate nutritional supplements, such as lutein, vitamin C, and foods rich in collagen (e.g. beef tendons). We can drink goji berry and chrysanthemum tea to slow down the aging of the vitreous humor.

References:

National Eye Institute, Kaohsiung Veterans General Hospital, Kuo General Hospital, and Lin Hsin Hospital

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What Are These Things Floating in Front of My Eyes? - The Epoch Times

Adverum Biotechnologies, Inc.

- Study participants had an 81%-98% reduction in annualized anti-VEGF injections and demonstrated continuous aflibercept expression levels through three years

- Mean best-corrected visual acuity and central subfield thickness were maintained or improved in subjects treated with ADVM-022

-The Phase 2 LUNA trial is expected to dose the first subject in the third quarter of 2022 and preliminary data anticipated throughout 2023

REDWOOD CITY, Calif., July 15, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced new data from the OPTIC study treating wet age-related macular degeneration (wet AMD) during the American Society of Retina Specialists (ASRS) 2022 Annual Meeting. New data presented are as of February 24, 2022 and include best-corrected visual acuity (BCVA) and central subfield thickness (CST) maintenance, as well as reduction in CST fluctuation after a single, in-office intravitreal (IVT) injection of ADVM-022, ixoberogene soroparvovec (Ixo-vec), in subjects requiring frequent anti-VEGF injections for their wet AMD.

We are pleased to present our findings on BCVA and CST from the OPTIC trial, establishing that maintenance in both BCVA and CST, as well as a reduction in CST fluctuations, were sustained through at least two years, suggesting the long-term durability of Ixo-vec after a single IVT injection, stated Richard Beckman, M.D., chief medical officer at Adverum Biotechnologies. As several publications have recently highlighted, retinal CST fluctuations over time are associated with poor long-term visual outcomes for patients. The combination of durable maintenance of BCVA and reduced CST fluctuations in subjects who previously required frequent IVT injections further support our belief that Ixo-vec can provide better long-term benefit for wet AMD patients. We are excited by the possibility of extending the treatment benefit for this lifelong disease from the order of months to the order of years.

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Data Highlights as of February 24, 2022

OPTIC trial participants had an 81%-98% reduction in annualized anti-VEGF injections and demonstrated continuous therapeutic aflibercept protein expression levels through three years following a single, in-office intravitreal injection of ADVM-022.

Mean BCVA (ETDRS) change from baseline to last visit was maintained or improved for two years post-treatment with ADVM-022 across both the 6x10^11 vg/eye (6E11) and 2x10^11 vg/eye (2E11) dose levels.

Mean CST was reduced by 55.7 m at the 6E11 dose (p=0.014) and by 95.9 m at the 2E11 dose (p=0.015) and maintained for two years following treatment across both ADVM-022 dose levels.

In the 2E11 dose in subjects with neutralizing antibodies (NAb) titers <1:125, subjects demonstrated a mean BCVA improvement of 5.2 letters for two years following treatment with ADVM-022.

ADVM-022 was well tolerated, with no participants in the 2E11 dose group requiring any topical corticosteroids to treat inflammation at most recent follow-up.

No evidence of correlation between baseline NAbs and occurrence of inflammation or other safety events has been observed.

We are excited to present these encouraging data, showing continuous and stable aflibercept expression for over three years in our OPTIC trial in subjects with wet AMD, commented Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies. As we recently announced, we completed our IND amendment with the U.S. Food and Drug Administration, received European Medicines Agency PRIME designation, and are preparing to initiate the Phase 2 LUNA trial of Ixo-vec in wet AMD. The LUNA trial was designed after a detailed data review from all 55 participants treated to date with a single ADVM-022 injection. Four new enhanced prophylactic steroid regimens will be evaluated in LUNA with the aim of providing steroid coverage during the period of peak immunogenicity. Our goal is to enhance the safety profile of ADVM-022 while building upon the impressive efficacy profile we continue to see in the OPTIC trial. We plan to dose the first subjects in the third quarter of 2022 and anticipate preliminary data from LUNA throughout 2023 and look forward to providing more detail on the expected timeline once we can assess the pace of enrollment.

The LUNA trial is a multicenter, double-masked, randomized, parallel-group Phase 2 trial evaluating two doses of Ixo-vec, including 2E11 and a new, lower 6x10^10 vg/eye (6E10) dose, in up to 72 patients with wet AMD. The LUNA trial will assess four new enhanced prophylactic steroid regimens, including local steroids and combinations of local and systemic steroids to test the relative contribution of local versus systemic AAV exposure on ocular inflammation. Specific regimens include topical difluprednate (Durezol), IVT Ozurdex, or a combination of either topical Durezol or IVT Ozurdex with oral prednisone.

The trial will randomize the participants equally between the 2E11 and 6E10 Ixo-vec doses across four prophylactic steroid regimens and will be conducted at approximately 40 sites in the U.S. and Europe. The primary endpoints will be similar to the OPTIC trial and focus on mean change in BCVA and CST from baseline to one year, and incidence and severity of adverse events. Other data points will include protein expression of aflibercept starting at 10 weeks and an interim analysis at 26 weeks. The study will also evaluate the effectiveness and tolerability of the prophylactic steroid regimens.

As an investigator in OPTIC, I have observed the potential of ADVM-022 to significantly reduce the treatment burden for my patients with neovascular age-relatedmacular degeneration. In the latest data from the OPTIC trial, we have seen a manageable safety profile, robust aflibercept expression, and sustained anatomical improvements after two years following a single 2E11 dose of ADVM-022, said Dante Pieramici, M.D., partner, California Retina Consultants, and presenter of the data at ASRS. I look forward to participating as a LUNA investigator and building on the efficacy and safety profile in OPTIC with a new, lower 6E10 dose and to determine an optimal prophylactic steroid regimen for patients.

About Wet Age-Related Macular Degeneration

Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of patients living with AMD. Wet AMD is a leading cause of blindness in patients over 65 years of age, with a prevalence of approximately 20 million individuals worldwide living with this condition. The incidence of new cases of wet AMD is expected to grow significantly worldwide as populations age. AMD is expected to impact 288 million people worldwide by 2040, with wet AMD accounting for approximately 10% of those cases.

About OPTIC Trial of ADVM-022 in Wet AMD

ADVM-022 is Adverums clinical-stage gene therapy product candidate being developed for the treatment of wet AMD. ADVM-022 utilizes a propriety vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. Unlike other ophthalmic gene therapies that require a surgery to administer the gene therapy under the retina (sub-retinal approach), ADVM-022 has the advantage of being administered as a one-time IVT injection in the office and is designed to deliver long-term efficacy and reduce the burden of frequent anti-VEGF injections, optimize patient compliance, and improve vision outcomes for patients with wet AMD.

The OPTIC trial is designed as a multi-center, open-label, dose-ranging, safety and efficacy trial of ADVM-022 in patients with wet AMD who have demonstrated responsiveness to anti-VEGF treatment. Patients in OPTIC are treatment-experienced, and previously required frequent anti-VEGF injections to manage their wet AMD and to maintain functional vision.

About Adverum Biotechnologies

Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage company that aims to establish gene therapy as a new standard of care for a number of highly prevalent ocular diseases with the aspiration of developing functional cures for these diseases to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary, intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ADVM-022, ixoberogene soroparvovec (Ixo-vec), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe. For more information, please visit http://www.adverum.com.

Forward-looking Statements

Statements contained in this press release regarding events or results that may occur in the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding Adverums plans to initiate a Phase 2 study in wet AMD to investigate the 2x10^11 vg/eye dose and a lower 6x10^10 vg/eye dose of ADVM-022, as well as new enhanced prophylactic steroid regimens, including local steroids and a combination of local and systemic steroids, planned for the third quarter of 2022, as well as the benefits Adverum expects from this trial, and the timing of preliminary data from the LUNA trial. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including risks inherent to, without limitation: Adverums novel technology, which makes it difficult to predict the timing of commencement and completion of clinical trials; regulatory uncertainties; enrollment uncertainties the results of early clinical trials not always being predictive of future clinical trials and results; and the potential for future complications or side effects in connection with use of ADVM-022. Additional risks and uncertainties facing Adverum are set forth under the caption Risk Factors and elsewhere in Adverums Securities and Exchange Commission (SEC) filings and reports, including Adverums Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 filed with the SEC on May 12, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Corporate & Investor Inquiries

Anand ReddiVice President, Head of Corporate Strategy and External Affairs & EngagementAdverum Biotechnologies, Inc.T: 650-649-1358E: areddi@adverum.com

Media

Megan TalonAssociate Director, Corporate CommunicationsAdverum Biotechnologies, Inc.T: 650-649-1006E: mtalon@adverum.com

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Adverum Biotechnologies Presents Best-Corrected Visual Acuity and Central Subfield Thickness Analyses After a Single IVT Injection of ADVM-022...

By Dr. Rajesh R

The World Retinoblastoma Awareness Week is observed every year in May. This year it falls between May 8-14, when healthcare providers around the world come together to create public awareness about retinoblastoma. It is the most common and life-threatening eye cancer in children, less than five years of age. It can affect any socio-economic group without any racial or gender preference. It can affect either one or both eyes. It is a type of eye cancer that begins in the retina the sensitive lining inside the eye. It is quite rare and is usually caused by a genetic mutation that makes the cells in the eye multiply rapidly and thereby forming an abnormal growth. With improved techniques, the survival of children with Retinoblastoma has improved but low awareness is still a cause of concern. Hence early detection and treatment is vital to control the malignant growth, thereby saving the vision and childs life.

Every year, almost 1 in 10,000 live births in the world has retinoblastoma and India has been proposed to have 3 times this global average and recorded as the highest number of affected children in the world. While the survival rate for retinoblastoma is over 95% in the developed countries, it is around 40-75% in developing nations like India due to a combination of multiple factors like poverty, illiteracy, lack of awareness, delay in seeking medical attention, and lack of access to healthcare resources. The care of retinoblastoma children during the pandemic was challenging as the nationwide lockdown had deprived retinoblastoma patients of optimal management. The entire impact of the pandemic on retinoblastoma management is still not known, but it is important to increase awareness of the timeliness of diagnosis and treatment.

SYMPTOMS

Some early cancers may have signs and symptoms that can be noticed, but that is not always the case. At early stages, the symptoms might be very subtle due to which the child may seem fit, but delay in diagnosing retinoblastoma can lead to advanced stages at presentation which may necessitate prompt removal of the affected eye. The most common presentation of this disease is with abnormal light reflex white eye, or cats eye reflex noted usually by neighbours or relatives. This is easily identified using flashlight photography seen as a white reflex. Crossed eyes or squint, swelling, irritation and endless watering are other common symptoms. The vision is lost rapidly and the child might frequently bump into objects and get hurt. There are other eye diseases which may present with similar signs and symptoms as retinoblastoma. This has to be confirmed after evaluation by an ocular oncologist.

DIAGNOSIS &TREATMENT

When diagnosed early there is good chance of both vision and eye-ball preservation. In some cases, when diagnosed late, the eye-ball might have to be removed to prevent spread of the cancer in the whole body. Scans and other imaging tests can help your childs doctor determine whether retinoblastoma has grown to affect other structures around the eye. With advanced chemotherapy techniques and local forms of therapy, we are able to preserve vision also in many cases. Retinoblastoma requires multidisciplinary coordinated care, and it requires involvement of multiples specialties, including ophthalmology, oncology, radiology, genetics, anaesthetist and others.

PREVENTION

Since retinoblastoma is inherited mostly from the genes, there are no fixed measures of prevention. But keeping optimal care of your eyes on a regular basis may help reduce the risk. Awareness on retinoblastoma is very crucial, especially when the world is amidst a pandemic. Many patients have reported eye infections post-covid and that should not be neglected. Eye infections might look like a small issue, but if not treated can turn fatal, hence we should always indulge in regular medical check-ups, particularly for children as precaution is always better than cure.

It is important to note that there is a chance of the cancer returning even after completing the treatment for retinoblastoma. Furthermore, children who have inherited this genetic mutation have a high chance of developing cancer in other parts of their body as well, hence regular follow-ups and screening is essential.

(The author is Consultant, Vitreoretina and Ocular Oncology Sankara Eye Hospital, Bangalore. The article is for informational purposes only. Please consult medical experts and health professionals before starting any therapy, medication and/or remedy. Views expressed are personal and do not reflect the official position or policy of the FinancialExpress.com.)

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Retinoblastoma among children: Early detection and treatment are vital - The Financial Express

Perceive Biotherapeutics is focused on the discovery and development of transformative gene therapies and other therapeutics for ocular diseases with high unmet need. By leveraging deep genetic understandings, Perceive Bio researchers have discovered key protective biological targets that uniquely position the Company to accelerate the development of best-in-class therapies for programs that represent over 50% of currently untreatable causes of blindness. Perceive Bio is advancing therapeutic programs in AMD, glaucoma, and additional undisclosed disease areas.

"Dr. Anne Fung is a unique force in clinical leadership," said K. Angela Macfarlane, CEO of Perceive Biotherapeutics. "She is dedicated to advancing science to help patients preserve their vision. As a practicing retinal specialist, Anne ran both investigator-sponsored and industry-sponsored multi-center trials prior to joining industry. We believe Perceive Bio's pipeline of ophthalmic drugs and technology platforms, complemented by Anne's leadership, positions us to transform care with protective therapeutics."

"We look forward to collaborating with Anne and the Perceive Bio team," said Jeffrey S. Heier, MD, Director, Retina Research, Ophthalmic Consultants of Boston, and member of the Perceive Bio Medical Advisory Board. "Her success in developing and launching novel, groundbreaking therapies in ophthalmology is well recognized. Genetically informed, sustained therapies are important and have the potential to have meaningful impact in our spectrum of patient care."

Dr. Fung joins Perceive Biotherapeutics following eight years of leadership at Genentech, a member of the Roche Group. During her tenure, she led the US Medical Affairs Ophthalmology team to advance clinical research in AMD, diabetic eye disease and other ocular conditions with an expansion from Lucentis to lampalizumab (GA), faricimab (DME/AMD) and the Port Delivery System (AMD/DME/DR). In 2019, she was selected to become the Global Development Lead for the Port Delivery System, where she led the team through key aspects of development and through Phase 3 trials of the first long-acting neovascular AMD therapy which received FDA approval in 2021 (SUSVIMO). Over two decades, Anne has pursued a passion for research of age-related macular degeneration and ophthalmology in academic, private practice, and biotech industry settings with US and global collaborators. Her research spans RPE transplantation, cataract biology, real-time OCT imaging observations of the effects of anti-VEGF on neovascular AMD and clinical applications of Lucentis globally, resulting in multiple publications, presentations and book chapters that have helped shape the current practice of care for neovascular AMD globally.

Dr. Fung is active in medical retina clinical practice in San Francisco and serves as the Research Chair for the Ophthalmology resident research program at California Pacific Medical Center. A graduate of Wellesley College and Cornell University Medical College, Anne completed her Ophthalmology residency at Stanford University Medical Center and a fellowship in Medical Retina at the Bascom Palmer Eye Institute in Miami.

"I have been passionate about retinal research and finding new solutions for over 20 years," said Dr. Fung. "I see the key pieces of science coming together at Perceive Bioto bring even more hope and vision to patients around the world."

About Perceive Biotherapeutics

Perceive Biotherapeutics is advancing a deep and diversified pipeline of targets and treatment modalities in multiple therapeutic verticals, with lead pipeline programs in ophthalmology. Perceive was founded on compelling research elucidating two novel protective biologies for treating retinal blindness, developed from foundational collaborations in genetic science and target validation. The Company is backed by Deerfield Management and will be raising a Series B later this year. For more information, please visit http://www.perceivebio.com

SOURCE Perceive Biotherapeutics, Inc.

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Perceive Biotherapeutics Appoints Anne E. Fung MD, as Chief Medical Officer to Drive Transformational Clinical Programs - PR Newswire

Findings from First-in-Human Study Support Continued Clinical Development of Investigational IOP-lowering Therapy; New Trials Planned as Complementary Glaucoma Treatment and in Rare Pediatric Indication

WELLESLEY, Mass., May 18, 2022--(BUSINESS WIRE)--Qlaris Bio, Inc. (the "Company" or "Qlaris"), a biotechnology company targeting high unmet needs in debilitating ophthalmic diseases, today announced results from QC-201, a first-in-human, Phase 2 clinical trial of QLS-101, the Companys investigational therapy for lowering intraocular pressure (IOP) in the treatment of glaucoma. Study findings demonstrated a favorable safety and tolerability profile for QLS-101, including no evidence of hyperemia (eye redness), as well as a positive efficacy signal, in patients with primary open-angle glaucoma (POAG) or ocular hypertension.

These data support the ongoing clinical development of QLS-101 and Qlaris intends to initiate several new studies designed to further assess the potential role of the compound as a first-in-class glaucoma treatment. Additional clinical trials will seek to evaluate QLS-101 as a complementary therapy to available glaucoma treatments and procedures, such as prostaglandin analogs and minimally invasive glaucoma surgery (MIGS), and as a treatment for juvenile patients with Sturge-Weber syndrome (SWS)-related glaucoma.

QLS-101 is a novel adenosine triphosphate (ATP)-sensitive potassium (KATP) channel modulator administered as a topical eyedrop. Unlike currently available therapies for lowering IOP in glaucoma, QLS-101 targets distal outflow resistance and episcleral venous pressure (EVP), a key component of IOP. QLS-101 improves the outflow of aqueous humor by widening outflow channels and the episcleral vessels of the eye distal to the trabecular meshwork to lower IOP.

"These Phase 2 data are encouraging, particularly the absence of hyperemia, which is a common side effect with certain glaucoma treatments and one which can lead patients to discontinue therapy," said Thurein Htoo, MS, MBA, chief executive officer and co-founder of Qlaris Bio. "With the well-tolerated safety profile and efficacy signal demonstrated in this study, we believe QLS-101 can serve as a compelling complement to existing drugs and drainage devices to help patients for whom EVP and distal outflow resistance may be pathologic or treatment-limiting."

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"As a clinician, I often see glaucoma patients whose vision loss continues to progress even when treated with current therapeutic options that target different components of IOP than EVP," said Barbara Wirostko, MD, FARVO, chief medical officer and co-founder of Qlaris Bio. "QLS-101 may provide a first-in-class mechanism of action to lower IOP by focusing on resistance distal to the trabecular meshwork of the eye that is not yet fully addressed by available therapies. We look forward to initiating additional studies pursuing these new solutions."

POAG is the most common adult form of glaucoma and remains one of the leading causes of preventable blindness worldwide. Elevated IOP remains the only modifiable risk factor for progression of glaucoma. Despite available therapies and surgical interventions, patients with POAG may not achieve IOP-lowering goals as available options only target three components of IOP. This leaves the fourth component of IOP EVP insufficiently addressed.

"The results from the QC-201 trial are promising and certainly should prompt continued study of the potential impact of this promising investigational therapy," said Sharon F. Freedman, MD, professor of ophthalmology and pediatrics at Duke University Medical Center, and a principal investigator in ongoing Qlaris trials. "An EVP-targeting therapy could also address a significant unmet need for patients living with certain types of glaucoma, such as Sturge-Weber syndrome. I look forward to continued collaboration with Qlaris on this important work."

SWS is a pediatric rare disease signified by a facial port wine birthmark. Individuals living with SWS often suffer from severe, intractable glaucoma in the eye on the same side as their birthmark. In these individuals, increased IOP is driven by pathologically elevated EVP. By directly lowering EVP, QLS-101 may be uniquely well-suited to address SWS and improve therapeutic outcomes.

About QLS-101

QLS-101, Qlaris Bios lead product candidate, is a prodrug of levcromakalim, an adenosine triphosphate (ATP)-sensitive potassium (KATP) channel modulator. By lowering episcleral venous pressure (EVP) and increasing aqueous humor outflow through vessels distal to the trabecular meshwork, QLS-101 may be able to uniquely address diseases of pathologic EVP resulting in elevated intraocular pressure (IOP), such as Sturge-Weber syndrome-related glaucoma, and diseases where EVP limits maximal therapy, including primary open-angle glaucoma and normal-tension glaucoma. QLS-101 was invented at Mayo Clinic and the University of Minnesota and is being developed under an exclusive worldwide license.

About Qlaris Bio, Inc.

Qlaris Bio, Inc. was founded in August 2019 with a singular focus: to develop novel, innovative therapies with first-in-class mechanisms of action to address serious and debilitating ophthalmic diseases. The companys lead platform is based on the use of adenosine triphosphate (ATP)-sensitive potassium (KATP) channel modulators to affect the tone of vascular and vascular-like tissues, initially focused on ophthalmic use. Qlaris Bios investors include Canaan and New Leaf Venture Partners, both of which were co-lead investors in the companys $25 million Series A round in August 2019. Other investors include Correlation Ventures and Mayo Clinic. For more information, please visit qlaris.bio.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220518005187/en/

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Media Contact Matt Pera973-886-9150matt.pera@smithsolve.com

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Qlaris Bio Reports Phase 2 Clinical Trial Results Demonstrating Favorable Safety and Tolerability Profile and Positive Efficacy Signal for QLS-101 -...

Illustration by Brendan Totten

Helene Macedo didnt think about it much when her headache started around noon.

It was Oct. 26, 2020, and the nurse and case manager at Rhode Island Hospital was in the midst of a very busy Monday. Elective surgeries had resumed at hospitals around the state, but COVID-19 was still in full swing, and case numbers were beginning to creep toward a winter surge. Nursing homes were still seeing waves of infection, and Macedo was having trouble finding somewhere to discharge patients when they left hospital care. A nurse in the intensive care unit, operating room and recovery room for three decades before shifting to case management in 2018, she knew the importance of getting healthy patients out of the hospital quickly to free up beds for newer, sicker ones coming in.

There was a lot of pressure every day. You would come in, the rules would be changing everywhere in the state with COVID, and it was just a very stressful time, she says.

Fully masked and too busy to think about drinking water, she assumed she was dehydrated. It wasnt until she sat down for lunch around 3 p.m. that she knew something was wrong.

All of a sudden I started to eat and I was like, Oh my God, I cant taste my food. Panic set in, because especially then, that was the big thing. You lose your taste and smell, she says.

She immediately left for home to begin what she expected would be a two-week period of isolation and rest. A positive test the next day confirmed she had COVID-19. For the next few weeks, crippling headaches and fatigue like shed never before experienced kept her mostly confined to her bed. After about a month, the headaches began to subside, only to bereplaced by cardiac symptoms like chest pain and an elevated heart rate. A former marathon and triathlon runner who worked out six days a week, Macedo now found herself winded from walking to the end of her driveway. Tests revealed she had myocarditis, a swelling of the heart muscle seen in some patients with COVID-19, as well as pericardial effusion, a buildup of fluid around the heart.

As the weeks wore on, she began noticing other things. Simple tasks that were once routine now left her stumped and forgetful. Conversations were difficult to remember, and driving to her husbands workplace a short distance away from her Cranston home now proved impossible without GPS. Cooking, a favorite activity, became a minefield as she struggled to focus on simple recipes with no sense of taste to guide her.

To go from that level of functioning to literally barely making it through a day at home was just that was eye-opening, she says. It starts to play with your head a little bit.

Difficulty concentrating, chest pain and shortness of breath are all symptoms of what the Centers for Disease Control and Prevention calls post-COVID conditions, better known as long COVID. In January of 2021, Macedo began visiting Lifespans Long Covid Clinic for patients experiencing symptoms weeks or months beyond their initial infection. She took a leave of absence from work while following a regimen of physical therapy and medication to get back to her functioning self. Nine months after her initial positive test, she finally felt ready to return. She resumed her old job at Rhode Island Hospital in July 2021, starting off in four-hour shifts. Anything more, and the headaches would return, bringing with them the fatigue that forced her back to bed.

Every day that would go by that I was not able to go back to work I was getting more nervous and sad thinking, Oh my God, what if I dont return to work? she says.

Helene Macedo spent nine months away from her job at Rhode Island Hospital after contracting long COVID. Photography by Alex Gagne.

Macedos Story of anxiety, illness and a life disrupted by COVID-19 is familiar to those living through the front lines of the pandemic. Though most health care workers evaded the debilitating effects of long COVID, nearly all have faced the strain of working under the constant threat of a potentially life-altering illness, made real by the suffering of patients every day. For most, the toll has been not physical but mental as pandemic life brought years of stress and burnout beyond their breaking point, forcing front-line medical workers across the industry to adjust their lives as a result.

I feel like in medicine, its always a balance of wins and losses. You have this bucket thats about half-full all the time because if it was too full, it would bubble over, says Dr. Bradley Collins, a hospitalist at Miriam Hospital. With the pandemic, it was just constantly being at patients bedsides, holding iPads for them when they were dying so they could say their farewells to their family members, understanding that people couldnt visit because we had to try to keep the public safe. We didnt have those wins to sort of empty the bucket a little bit. I think it got to a point for some of us where that got so full, even little things would cause it to spill over.

Jacqueline Insana, a psychiatric nurse working in Rhode Island, describes the large number of patients in need of behavioral and mental health services as a second pandemic. As levels of anxiety and depression have increased nationwide, so too have the needs of providers who care for patients. Sometimes, she says, shell receive texts or phone calls from friends working in health care seeking advice regarding their own mental health where to find a therapist, or whether they should seek out professional help.

To go from that level of functioning to literally barely making it through a day at home was just that was eye-opening. It starts to play with your head a little bit. HELENE MACEDO

Nurse Karen Dreyer interacts with assistant nurse manager Emily Breguet in the neonatal intensive care unit at Women and Infants Hospital. Photography by Alex Gagne.

Probably a couple months in I saw a lot more nurses saying, Hey, Im not sleeping. Im struggling with this, Im not sure I can go to work anymore. Im crying on my way home; what are resources I can reach out to to make sure Im OK?

Dr. Nadine Himelfarb, an emergency medicine physician and president of the Rhode Island chapter of the American College of Emergency Physicians, has been studying burnout for more than ten years. The term is commonly attributed to Herbert Freudenberger, a New York psychologist who in the 1970s used it to describe the physical and emotional exhaustion among volunteers and workers at an addiction clinic, including himself. In 1981, Christina Maslach developed a scale for assessing burnout, establishing emotional exhaustion, depersonalization and a reduced sense of personal accomplishment as the three factors widely used to determine burnout in individuals. In her own view, Himelfarb says burnout is often the result of a values mismatch where someones experience of a job does not align with the reason they entered that field in the first place.

Everybody goes into medicine because of some version of I want to help people, she says. And what happens is you get into medicine, and you have to practice medicine within what has become the confines of the business of medicine, which is not always patient-centered. It is certainly not a system that oftentimes is set up to allow physicians to have the impact that they want or help people in the way that they see people need to be helped.

Himelfarb experienced this in the fall of 2020 when she took a three-month sabbatical. At the time, she was working sixty hours per week between her clinical and academic responsibilities. Combined with the daily realities of working through a pandemic undressing on the front porch after every shift to protect her immunocompromised husband and four children she soon realized she needed to make a change.

It was in August of 2020, and I realized that I was feeling this way. I had been working, I dont know, a bunch of shifts in a row, and then I knew that I had a week off and I had this vacation, she recalls. That weekend, I felt like I could hardly get out of bed. I just had no energy. I didnt know what was going on.

Despite her research into the subject, Himelfarb didnt immediately recognize her symptoms as burnout. It was only when she noticed they disappeared when she was no longer thinking about work that she realized she was experiencing what shed studied for so long.

The impact of burnout on physicians has been well documented. In a 2011 study, researchers found 45.8 percent of physicians surveyed reported at least one symptom of burnout, a number that increased to 54.4 percent in 2014. A 2017 follow-up study found burnout among physicians had decreased to 2011 levels, around 43.9 percent, but physicians were still more likely than the general population to feel burned out or be dissatisfied with their work-life balance. Likewise, physicians suffer from higher rates of suicide than the general population. Researchers estimated in a 2018 study that the physician suicide rate was twenty-eight to forty per 100,000, more than twice the general population rate of 12.3 per 100,000.

Kathleen Boyd is the director of the Rhode Island Medical Societys Physician Health Program, a resource set up in 1978 to assist physicians experiencing health issues, including psychiatric and substance use disorders. In 2021, the program had its busiest year to date, with thirty-ninereferrals. Many of those were for medical professionals experiencing burnout or health issues such as increased substance use, anxiety, depression and post-traumatic stress disorder. The spike came after an initial lull in 2020, which Boyd attributes to physicians not having the time to seek help during the early months of the pandemic.

I think one of the things that happened for front-line physicians was it was difficult to have time for self-care, she says. Everybodys flat out. Getting help is really about self-care, and you have to kind of fit that into your schedule. For many of the front-line people, there wasnt time for that.

The trend of medical professionals struggling with burnout or mental health issues is not unique to the pandemic. Among the most common reasons for burnout cited by physicians in surveys conducted both before and during the pandemic is too much time spent on bureaucratic tasks, including charting requirements and paperwork. Other factors include long hours, a lack of respect from administrators or colleagues, insufficient compensation and the expanded use of electronic health records for patient documentation.

Thats what we hear, Boyd says. I see thirty patients or fifty patients, and then I go home and have dinner and help my kids with their homework, and then I do my charting until midnight. And thats kind of whats burning people out. Its really hard to have that boundary around your work life and your home life. Its tough.

In nurses, too, the effects of burnout can be long-lasting. A 2021 survey by the American Nurses Foundation found 34 percent of nurses considered themselves not or not at all emotionally healthy, and 42 percent said theydexperienced trauma as a result of COVID-19. Twenty-one percent said they planned to leave their positions within the next six months, while another 29 percent were considering leaving.

Dreyer speaks with nurse Danielle Buzzell. Photography by Alex Gagne.

Boyd talks about how the application of business models to health care, including the introduction of productivity quotas, has changed the experience for professionals working in the industry.

Were in the business of caring for others, and if your capacity for compassion becomes crushed, its compassion fatigue. And your ability to connect with your patients is also crushed because youre only allowed ten minutes to connect with them, then whats left? I think there are an awful lot of physicians who are leaving the field. And nurses, too. Theres just a lot of people who are like, theyre done, she says.

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How the Pandemic is Taking a Toll on Rhode Island's Front-Line Health Care Workers - Rhode Island Monthly

WAKEFIELD, Mass.--(BUSINESS WIRE)--Myrtelle Inc. (Myrtelle or the Company), a clinical stage gene therapy company focused on developing transformative treatments for rare genetic diseases, today announced that it has entered into a worldwide exclusive licensing agreement with Rescue Hearing Inc. (RHI) to develop a novel gene therapy for DFNB8 genetic hearing loss. The low-dose recombinant adeno-associated virus (rAAV) gene therapy is intended to deliver a therapeutic TMPRSS3 (transmembrane protease, serine 3) gene by local administration directly to the inner ear. Mutation in the TMPRSS3 gene is the underlying cause of DFNB8 genetic hearing loss in humans. Across its gene therapy programs, Myrtelle utilizes direct administration of low-dose gene therapy to target key cell types involved in the disorder, thereby avoiding immune-related and off-target effects that can arise with high-dose gene therapy administration delivered systemically. This strategy, currently being developed for Myrtelles central nervous system (CNS) programs, can be leveraged to other therapeutic areas outside the CNS, including adjacent and related areas such as the ear where local gene therapy delivery is potentially advantageous for hearing loss disorders such as DFNB8.

We are excited to partner with RHI on this important potential gene therapy for patients with DFNB8 genetic hearing loss. The program will leverage Myrtelles core capabilities and augment our product opportunities to build on the proof-of-concept demonstrated by RHI and move toward the clinic to advance a novel therapeutic approach for patients with DFNB8 genetic hearing, said Mark Pykett, Myrtelle CEO, adding, The potential significance of this new therapeutic hearing loss strategy for patients and families is high.

Preclinical studies in the mouse model of DFNB8-mediated deafness have demonstrated that delivery of a wild type TMPRSS3 gene was able to promote hair cell and neuron survival and improve hearing function. Recently, a successful meeting was held with German health authorities and the Paul Ehrlich Institute to discuss clinical trial authorization (CTA) requirements for starting a first-in-human study. CTA-enabling nonclinical work is currently planned to start later this year to meet these requirements.

RHI is a private, preclinical stage gene therapy company focusing on diseases affecting human hearing. The DFNB8 program targets a common form of genetic hearing loss caused by a mutation in the TMPRSS3 gene. TMPRSS3 mutation is the most common form of genetic deafness in the adult cochlear implant population. DFNB8 patients experience progressive hearing loss usually starting in late teens and early 20s which can lead to complete deafness. RHIs initial preclinical research has demonstrated positive proof-of-concept data enabling entrance to the IND development phase.

We are pleased to partner with Myrtelle on this exciting program. Myrtelles team and their drug development experience are an outstanding fit for the TMPRSS3 AAV-based gene therapy program for DNFB8-related genetic hearing loss. The groundbreaking proof-of-concept data generated by our scientific team lead by Dr. Hinrich Staecker (University of Kansas Medical Center), Dr. Zheng Yi Chen (Mass Eye and Ear Infirmary), and Dr. Xue Zhong Liu (University of Miami Health System) provide a strong foundation for further development. The RHI team is proud to have brought the TMPRSS3 program to this exciting stage and look forward to advancing the program into the clinic with Myrtelle with the goal of developing a novel therapy to positively impact unmet medical needs of the genetic hearing loss community, said Jim Ayala, CEO/Founder Rescue of Hearing.

ABOUT MYRTELLEMyrtelle Inc. is a clinical stage gene therapy company focused on developing transformative treatments for neurodegenerative diseases. The company has a proprietary platform, intellectual property, and portfolio of programs and technologies supporting innovative gene therapy approaches for neurodegenerative diseases. Myrtelle has an exclusive worldwide licensing agreement with Pfizer for its lead gene therapy program in Canavan Disease. For more information, please visit the Companys website at: http://www.myrtellegtx.com.

RESCUE HEARING INCRescue Hearing Inc (RHI) is a private, preclinical stage gene therapy company focused on the genetic forms of hearing loss. RHIs initial product (RHI100) has produced positive proof of concept data and is entering the IND development phase. RHI100 targets a common form of genetic hearing loss caused by a mutation in the TMPRSS3 gene. TMPRSS3 mutation is the most common form of genetic deafness in the cochlear implant population. RHI has two additional gene therapy assets in development. For more information, please visit the companys website at: http://www.rescuehearing.com.

DFNB8Individuals with mutations in TMPRSS3 present with two phenotypes: DFNB10-associated hearing impairment that is pre-lingual and DFNB8-associated hearing impairment that is typically late-onset and post-lingual. TMPRSS3 mutations can be divided into mild or severe; the combination of two severe mutations causes profound pre-lingual hearing loss, whereas milder mutations lead to less severe post-lingual hearing loss.

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Myrtelle Enters into a Worldwide Exclusive License Agreement with Rescue Hearing to Develop and Commercialize Gene Therapy for the Treatment of...