FDA approves Syfovre for geographic atrophy
The U.S. Food and Drug Administration has approved pegcetacoplan injection (Syfovre; Apellis Pharmaceuticals) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), according to a press release. This is the first and only FDA-approved treatment for GA.
Syfovre is approved for patients with GA with or without subfoveal involvement
Approval is based on positive results from the Phase 3 OAKS and DERBY studies where Syfovre reduced the rate of GA lesion growth compared to sham and demonstrated increasing treatment effects over time, with the greatest benefit occurring between 18-24 months.
“The approval of Syfovre is the most important event in retinal ophthalmology in more than a decade,” said Eleonora Lad, MD, PhD, lead investigator for the OAKS study, director of ophthalmology clinical research, associate professor of ophthalmology, Duke University Medical Center in the press release. “Until now, there have been no approved therapies to offer people living with GA as their vision relentlessly declined. With Syfovre, we finally have a safe and effective GA treatment for this devastating disease, with increasing effects over time.”
Read the full press release here.
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