Geographic atrophy treatment receives approval by FDA
Hi All, Steven Ferrucci back at it with some breaking news on the treatment of Geographic Atrophy.
On February 17th, the FDA approved SYFOVRE™ - (pegcetacoplan injection) for the treatment of Geographic Atrophy. Geographic atrophy is a form of Dry Macular Degeneration that affects approximately 1 million Americans and is characterized by loss or atrophy of the RPE and retinal photoreceptors, leading to irreversible vision loss and visual function. Globally, Geographic Atrophy accounts for 20% of all legal blindness associated with AMD.
The medication, now called SYFOVRE, is a targeted C3 therapy designed to control excessive regulation of the complement cascade, part of the body’s immune system, which has shown to be a factor in the onset ad progression of Geographic Atrophy, among other diseases. SYVOFRE has been approved for intravitreal injection once a month to every other month for a period of 24 months in patients with Geographic Atrophy.
The OAKS and DERBY studies, both phase 3, multicenter, randomized, double-masked, controlled studies evaluated both the safety and efficacy of pegcetacoplan in patients with Geographic Atrophy. The studies showed approximately a 20% reduction in lesion growth at 1 year, which was sustained in studies through the second year. The medication was also proven to be safe, with relatively few serious adverse effects.
SYFOVRE is expected to be on the market by the beginning of March, according to Apellis.
This approval is very important, in my opinion, as it represents a significant step forward in the treatment of dry AMD, as this marks the first FDA approved treatment for dry AMD and offers hope to our patients with Geographic Atrophy. Furter, it will be interesting to see moving forward which patients are the best candidates for this treatment, and when they should be referred to a retinal specialist for treatment consideration for optimal results.
About Geographic Atrophy
Geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD), affects more than 5 million individuals globally, including 1 million people in the United States, and is the main cause of blindness. 5,6 Since it typically takes GA lesions 2.5 years to encroach on the fovea, which controls central vision, this degenerative disease can significantly impair visual function, independence, and quality of life. 7 GA is brought on by irreversible lesion growth brought on by excessive complement activation, which results in the loss of retinal cells. 8 Due to its central location, C3 is the only target that can precisely regulate the complement cascade. Currently, GA has no approved therapies.
About Visible Genomics
Visible Genomics, a data science company, is focused on improving patient care and providing the right tools for doctors. Visible Genomics provides a simple test using a patient’s DNA (cheek swab) and demographic factors to provide a risk assessment for Macular Degeneration and its progression. Click on Macular Degeneration Testing to learn more.