Sanofi's SAR446597 Receives US Fast Track Designation for Geographic Atrophy
The US Food and Drug Administration (FDA) has granted Fast Track designation to Sanofi's SAR446597, a one-time intravitreal gene therapy for geographic atrophy due to age-related macular degeneration. This designation aims to expedite the development and review of the treatment.
Paris, July 16, 2025. Sanofi announced today that its investigational gene therapy, SAR446597, has received Fast Track designation from the U.S. Food and Drug Administration (FDA). The therapy is intended for the treatment of geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD).
SAR446597 is designed as a one-time intravitreal gene therapy. It delivers genetic material encoding two therapeutic antibody fragments that target and inhibit key components of the complement cascade: C1s in the classical pathway and Factor Bb in the alternative pathway. This dual-targeting approach aims to provide sustained complement suppression within the retina, potentially reducing the need for frequent injections and addressing the underlying pathology of complement-mediated retinal diseases.
Sanofi plans to initiate a Phase 1/2 study to evaluate the safety, tolerability, and efficacy of SAR446597. Age-related macular degeneration affects approximately 200 million people globally, and GA can lead to irreversible vision loss. Approximately 1 million people in the US are affected by GA, significantly impacting their quality of life.
The company is also evaluating another investigational one-time intravitreal gene therapy, SAR402663, for neovascular (wet) AMD in an ongoing Phase 1/2 study. The Fast Track designation is intended to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill unmet medical needs.