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Apellis Announces Phase 3 Results for GA Treatment Pegcetacoplan
Apellis Pharmaceuticals reported top‑line data from its Phase 3 DERBY and OAKS trials of pegcetacoplan, an intravitreal C3‑targeted therapy for geographic atrophy (GA), an advanced form of age‑related macular degeneration. While DERBY did not meet its primary endpoint, OAKS succeeded, showing a 22%‑16% reduction in GA lesion growth versus sham at 12 months. In a pooled analysis, monthly and every‑other‑month dosing reduced lesion growth by 26% in patients with extrafoveal lesions. Pegcetacoplan was well tolerated in both studies. Apellis plans to submit a New Drug Application to the U.S. Food and Drug Administration in the first half of 2022. GA currently has no approved treatments and affects an estimated five million people worldwide, making these results a potential first therapeutic option.
Entities
Apellis Pharmaceuticals · Franz Badura · Geographic Atrophy · U.S. Food and Drug Administration · pegcetacoplan