Sanofi’s SAR446597 Gene Therapy for Geographic Atrophy Granted FDA Fast Track Designation

Paris, France – July 16, 2025 – Sanofi today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SAR446597, a one-time intravitreal gene therapy for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD). This designation aims to facilitate development and expedite the review of medicines for serious conditions with unmet medical needs, helping to deliver new drugs to patients sooner.

SAR446597 is designed to address the underlying pathophysiology of complement-mediated retinal diseases. It delivers genetic material encoding two therapeutic antibody fragments that specifically target and inhibit critical components of the complement pathway: C1s in the classical pathway and factor Bb in the alternative pathway. This dual-targeting approach aims to provide sustained complement suppression within the retinal microenvironment, potentially offering long-term expression of therapeutic proteins following a single intervention and significantly reducing the treatment burden of frequent intravitreal injections.

Sanofi plans to initiate a Phase 1/2 study to evaluate the safety, tolerability, and efficacy of SAR446597. The company is also currently evaluating SAR402663, another one-time intravitreal gene therapy, in a Phase 1/2 study for the treatment of patients with neovascular (wet) age-related macular degeneration.

About Age-Related Macular Degeneration (AMD) and Geographic Atrophy (GA): AMD is a progressive degeneration of the retina affecting approximately 200 million people globally. Geographic atrophy is an advanced form of dry AMD characterized by irreversible atrophic lesions, leading to permanent vision loss. GA impacts an estimated 1 million people in the U.S., over 2.5 million in Europe, and more than 5 million worldwide, profoundly impacting patients’ quality of life.