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# Gemini Therapeutics Fast Track for Macular Degeneration Drug
- URL: https://www.fdaweb.com/gemini-therapeutics-fast-track-for-macular-degeneration-drug/
- Published: 2021-01-07T12:00:00.000Z
- Updated: 2026-09-14T16:41:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148397

FDA has granted Gemini Therapeutics a fast track designation for GEM103, an investigational treatment for dry, age-related macular degeneration (AMD). Gemini says it is evaluating the recombinant, human complement factor H (CFH) for its ability to address multiple AMD pathobiologies in genetically-defined subsets of AMD patients caused by CFH loss-of-function variants and slow the progression of their disease. “CFH loss-of-function variants are present in approximately 40% of patients with AMD,” it says. The company’s ongoing Phase 2a ReGAtta study is evaluating GEM103 in patients with geographic atrophy secondary to dry AMD.