Sanofi's SAR446597 Receives Fast Track Designation in the US for Geographic Atrophy Linked to Age-Related Macular Degeneration
Wednesday, July 16, 2025
Sanofi has announced that the US Food and Drug Administration (FDA) has granted fast track designation to SAR446597, an investigational one-time intravitreal gene therapy, for the treatment of geographic atrophy (GA) caused by age-related macular degeneration (AMD).
The fast track designation is intended to speed up the development and review of medicines that address serious medical conditions and meet unmet clinical needs. The process supports earlier availability of important new therapies for a wide range of serious illnesses.
SAR446597 is designed to deliver genetic material that encodes two therapeutic antibody fragments. These fragments target and block two key components of the complement pathway—C1s in the classical pathway and factor Bb in the alternative pathway. This dual-targeting approach may provide long-lasting complement suppression in the retina while reducing the need for repeated intravitreal injections. The therapy is intended to tackle the underlying cause of complement-driven retinal disease through a single gene therapy procedure.
Sanofi plans to initiate a Phase 1/2 clinical study to assess the safety, tolerability, and preliminary effectiveness of SAR446597.
In addition, Sanofi is currently conducting a Phase 1/2 study of SAR402663, another one-time intravitreal gene therapy, for the treatment of neovascular (wet) age-related macular degeneration (clinical study identifier: NCT06660667).
Age-related macular degeneration is a progressive condition of the retina that affects around 200 million people globally. Geographic atrophy is an advanced form of dry AMD, marked by irreversible degeneration of retinal cells, leading to growing atrophic lesions and permanent vision loss. It significantly affects daily life, including reading, driving, and other essential tasks. GA impacts roughly 1 million people in the United States, over 2.5 million in Europe, and more than 5 million worldwide.
Source: globenewswire.com
