Apellis Gains Approval for SYFOVRE® (pegcetacoplan) in Australia to Treat Geographic Atrophy (GA)
Tuesday, January 28, 2025
Apellis Pharmaceuticals, Inc. has announced that the Therapeutic Goods Administration (TGA) in Australia has approved SYFOVRE® (pegcetacoplan) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This treatment, administered every other month, is intended for adults with an intact fovea and when central vision is at risk due to the growth of GA lesions. SYFOVRE is the first and only approved treatment for GA in Australia.
Geographic atrophy, a progressive and irreversible condition, is an advanced stage of AMD and a leading cause of blindness globally. In Australia, over 75,000 people are living with GA, which results in the destruction of retinal cells responsible for vision. This vision loss significantly impacts daily activities and reduces quality of life.
The approval is based on the outcomes of the Phase 3 OAKS and DERBY studies conducted over 24 months. These studies demonstrated that SYFOVRE, administered either monthly or every other month, slowed the progression of GA while maintaining a generally well-tolerated safety profile. The results were published in The Lancet in October 2023.
SYFOVRE (pegcetacoplan injection) is the first approved treatment specifically designed for GA. By targeting C3, it provides comprehensive control of the complement cascade, which is part of the immune system. SYFOVRE has also received approval in the United States.
Source: globenewswire.com
