FDA Approves SYFOVRE™ (pegcetacoplan injection) as the First and Only Treatment for Geographic Atrophy (GA), a Leading Cause of Visual Impairment in Senior Adults
Apellis Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved SYFOVRE™ (pegcetacoplan injection) 15mg/0.1mL, the first and only treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
No treatments have been available to slow this advanced form of dry AMD, but starting today, people living with GA have new hope.
The approval of SYFOVRE (pronounced “sigh-fove-ree”) is based on positive results from the Phase 3 OAKS and DERBY studies at 24 months across a broad and representative population of patients. With an optional dosing regimen of monthly or bi-monthly, SYFOVRE was shown to reduce the rate of retinal damage up to 36% compared to sham and demonstrated even more efficacy over time. In addition, it can be used in combination with anti-angiogenic drugs which have been treating the wet form of AMD since 2004. SYFOVRE will be covered by Medicare and is expected to be available in clinics by March.
The field of ophthalmic research has progressed so far in the treatment of wet AMD that we often forget that up to 85% of cases are of the previously untreatable dry form of the disease. Now the first and only intervention for GA is here. It is not a cure, but it might allow thousands of people to maintain useable vision for the rest of their lifetimes.
“For the first time ever, we are celebrating the approval of a treatment for GA,” said Jeff Todd, president and chief executive officer, Prevent Blindness. “This is a historic and hopeful day for all GA patients and their care partners, who have been waiting for a treatment for this relentless form of vision loss.”
For more information about safety considerations and treatment protocols, select this link.
Source: Apellis press release