David Hutton

Parexel teams with MyEyeDr. to leverage MyEyeDr.’s 850+ offices across the United States to refer patients into ophthalmology and other therapeutic area clinical trials, expands Parexel’s Community Alliance Network to bring trials to patients where they are.

According to the company, RZ402 is an oral therapy being developed as a potential alternative to invasive and suboptimal injections into the eye.

Investigators have found that cells within retinal blood vessels are endowed with a previously unappreciated ability to acquire resistance against the damaging effects of hyperglycemia in patients with diabetes mellitus.

According to the company, the IDMC recommended continuation of the study based upon the outcome of the futility analysis.

Harrow Health Inc. announced it has reached an agreement to purchase the exclusive U.S. commercial rights to 5 ophthalmic drugs from Novartis AG for up to $175 million, the company announced today.

The results represent a major step towards first in-human clinical studies for this program - the first potential therapy for patients with geographic atrophy secondary to AMD that addresses the underlying causes of the disease.

According to the AAO and Verana Health, the partnership seeks to increase clinical trials access, accelerate recruitment, and advance ophthalmic research.

According to a team of German investigators, visual cells in the human retina may not simply die in some diseases, but are mechanically transported out of the retina beforehand.

According to the company, OPGx-001 is Opus’ first program to enter clinical evaluation and is designed to address vision loss due to mutations in the LCA5 gene, which causes one of the most severe forms of early-onset blinding disease Leber congenital amaurosis.

A breakthrough gene therapy approach, SPVN06 is aimed at stopping or slowing disease progression in patients affected by IRDs and dry age-related macular degeneration (AMD), regardless of their genetic background.

According to a news release, the findings build on evidence from a previous study led by the Johns Hopkins researchers that found potentially a third of patients with wet AMD could safely pause therapy after one year of monitoring by a physician.

Ophthalmologists are now armed with new therapies to fight retinal disease.

Discovery CORE and its AI models have been designed to accelerate data analysis and help clinical and academic researchers collaborate more efficiently in real time with their peers on medical and imaging datasets.

In an effort to educate the public on geographic atrophy, Prevent Blindness has created a variety of resources in English and Spanish.

The company is currently developing sustained release ophthalmic therapeutics aimed at reducing the frequency of intravitreal injections required to treat a wide range of retinal diseases.

According to the company, the deal adds pharmaceutical research and development capabilities and further expertise for future product pipeline. It also expands Alcon’s presence in the $20 billion global ophthalmic pharmaceutical category.

The company noted the updated PDUFA goal date is February 26, 2023. The FDA also reiterated that they do not plan to hold an advisory committee meeting to discuss the application.

According to the company, LBS-008 is an orally administered tablet intended as an early intervention to slow disease progression in patients affected with Stargardt disease and dry age-related macular degeneration.

Delaying the disease can also delay any onset of vision problems, including diabetic retinopathy and diabetic macular edema.

According to the company, ROP Check builds upon its pediatric retina screening portfolio, adding digital management (schedule, document, bill, and transfer) for treating patients with retinopathy of prematurity.

RGX-314 is being investigated as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions.

A previously uncharacterized area of the protein known as RPE65 spontaneously turns spiral-shaped when it encounters intracellular membranes, or thin structures that surround different parts of a cell.

Genentech announced this week that faricimab-svoa (Vabysmo) achieved its primary endpoint of non-inferiority compared to aflibercept in RVO in the BALATON and COMINO clinical trials.

Scott Walter, MD, an investigator in the TENAYA and LUCERNE trials discusses the year 2 data for the treat-and-extend regimen of faricimab for the treatment of nAMD and DME.

The company noted that the pediatric exclusivity determination is based on data from two Phase 3 trials – BUTTERFLEYE and FIREFLEYE.

Carl Danzig, MD, points out that the sooner patients can be diagnosed, the sooner ophthalmologists can treat them and preserve their vision.

MCO-010, an ambient-light activatable multi-characteristic opsin optogenetic monotherapy for vision restoration in blind patients, received fast track designation from the FDA.

According to data released at the American Academy of Ophthalmology's 2022 annual meeting, a large number of wet AMD patients do not return for treatment.

Tom Ruggia, President and CEO of Samsara Vision, provides updates on the lead asset for late-state age-related macular degeneration: Smaller-incision, new generation, implantable miniature telescope (SING IMT).

Janssen noted that results from Phase 1/2 MGT009 study demonstrate safety profile of investigational gene therapy botaretigene sparoparvovec (AAV-RPGR) and suggest sustained vision improvement in patients with X-linked retinitis pigmentosa.