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# Apellis NDA Planned for Geographic Atrophy
- URL: https://www.fdaweb.com/apellis-nda-planned-for-geographic-atrophy/
- Published: 2021-11-12T12:00:00.000Z
- Updated: 2026-09-14T17:22:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150568

Apellis Pharmaceuticals says it will file an NDA during the first half of 2022 for intravitreal pegcetacoplan for treating geographic atrophy (GA) secondary to age-related macular degeneration. The announcement follows formal, written feedback from FDA that supports the planned submission, according to the company. The agency reportedly confirmed that all three studies on which the company is basing its submission appear to be adequate and well controlled.

GA is an advanced form of age-related macular degeneration, a leading cause of blindness. Its lesions affect the central portion of the retina (macula), which is responsible for central vision. The company describes pegcetacoplan as a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Previously, FDA granted a fast track designation for the therapy in the GA pateint population.