Workflow
SYFOVRE® (pegcetacoplan injection)
icon
Search documents
Apellis Announces 5-Year GALE Data Showing SYFOVRE® (pegcetacoplan injection) Delayed Progression of Geographic Atrophy by ~1.5 Years
Globenewswire· 2025-11-12 12:00
Core Insights - Apellis Pharmaceuticals announced positive long-term data from the GALE extension study, showing that SYFOVRE® significantly delays the progression of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) [1][2][3] Study Results - The analysis revealed that both monthly and every-other-month administration of SYFOVRE delayed GA lesion growth by approximately 1.5 years compared to a projected sham treatment [2][3] - The safety profile of SYFOVRE remained consistent over the five-year period, aligning with previously reported data [3] Study Design - The GALE study is a Phase 3, multicenter, open-label extension study involving 792 patients, aimed at evaluating the long-term efficacy and safety of SYFOVRE in GA patients [5] - More than 80% of participants from the earlier OAKS and DERBY studies transitioned into the GALE study [5] Mechanism of Action - SYFOVRE targets C3 in the complement cascade, providing comprehensive control of the immune response, which is crucial for managing GA [10] Disease Impact - Geographic atrophy is a leading cause of blindness, affecting over one million Americans and five million people globally, with significant implications for patients' quality of life [11]