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BioWorld - Sunday, May 18, 2025
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Home » After a three-month delay, Apellis sees its sight therapy approved
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After a three-month delay, Apellis sees its sight therapy approved

Feb. 21, 2023
By Lee Landenberger
After a delay in November that resulted in a new PDUFA date, Apellis Pharmaceuticals Inc.’s Syfovre (pegcetacoplan injection) received U.S. FDA approval for treating geographic atrophy (GA) secondary to age-related macular degeneration. While this is the first and only FDA-approved treatment for GA, there is competition afoot from Belite Bio Inc. and Iveric Bio Inc. The intravitreal targeted C3 therapy’s Feb. 17 approval of the priority NDA came more than a week ahead of its Feb. 26 PDUFA.
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