Apellis reports 24-month Phase 3 data: pegcetacoplan shows increasing efficacy in GA

Apellis Pharmaceuticals, Inc.

At 24 months, monthly pegcetacoplan reduced GA lesion growth 19% in DERBY (p=0.0004) and 22% in OAKS (p<0.0001) vs sham.
Between months 18-24, treatment effect accelerated: DERBY monthly 36% (p<0.0001), OAKS monthly 24% (p=0.0080) reduction.
Safety profile consistent; infectious endophthalmitis rate 0.034% per injection, no occlusive vasculitis or retinitis over 24 months.
US PDUFA target action date Nov 26, 2022; EU marketing authorization application planned by end of 2022.
Key secondary visual function endpoints showed no clinically meaningful difference at 24 months, attributed to endpoint limitations.

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