Apellis Pharmaceuticals announced the FDA approved its product Syfovre, also known as pegcetacoplan injection, for the treatment of geographic atrophy secondary to age-related macular degeneration, according to the press release.

This approval makes Syfovre the first and only treatment for geographic atrophy (GA), a leading cause of blindness in the world. The treatment has a well-demonstrated safety profile following approximately 12,000 injections over 24 months.

As Healio has previously reported, Apellis Pharmaceuticals investigated the efficacy and safety of a pegcetacoplan injection in the DERBY and OAKS studies. Results from the Phase 3 DERBY and OAKS studies showed that Syfovre reduced the rate of GA lesion growth compared with sham and increased treatment effects over time, according to the release.

“The approval of [Syfovre] is the most important event in retinal ophthalmology in more than a decade,” Eleonora Lad, MD, PhD, lead investigator for the OAKS study, director of ophthalmology clinical research and associate professor of ophthalmology at Duke University Medical Center, said in the 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.”

Syfovre is approved for use in patients with GA with or without subfoveal involvement and offers dosing flexibility with a dosing regimen of every 25 to 60 days. Syfovre is expected to be available nationwide by the beginning of March through specialty distributors and pharmacies. Apellis Pharmaceuticals is awaiting approval for a marketing authorization application for Syfovre by the European Medicines Agency and has submitted a marketing application for the injection treatment to Health Canada, according to the release.