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# Apellis Pharma Plan NDAs for Geographic Atrophy
- URL: https://www.fdaweb.com/apellis-pharma-plan-ndas-for-geographic-atrophy/
- Published: 2021-09-09T12:00:00.000Z
- Updated: 2026-09-14T17:13:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150118

Apellis Pharmaceuticals says it plans to file an NDA in the first half of 2022 after reporting top-line results from the Phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan, an investigational targeted C3 therapy, in 1,258 adults with geographic atrophy secondary to age-related macular degeneration. Geographic atrophy is a leading cause of blindness that affects about one million people in the U.S.

In the studies, pegcetacoplan demonstrated a clinically meaningful slowing of disease progression with an even stronger effect in geographic atrophy patients with extrafoveal lesions, the company says. “Monthly and every-other-month treatment with pegcetacoplan met the primary endpoint in OAKS, significantly reducing \[geographic atrophy\] lesion growth by 22% (p=0.0003) and 16% (p=0.0052), respectively, compared to pooled sham at 12 months,” it says. “DERBY did not meet the primary endpoint, showing a reduction in GA lesion growth of 12% (p=0.0528) and 11% (p=0.0750) with monthly and every-other-month treatment, respectively, compared to pooled sham at 12 months.”