The U.S. Food and Drug Administration (FDA) has granted fast track designation to Sanofi’s investigational gene therapy SAR402663 for treating neovascular age-related macular degeneration (AMD). This one-time intravitreal therapy is designed to deliver genetic material encoding soluble FLT01, which inhibits vascular endothelial growth factor (VEGF), aiming to reduce abnormal blood vessel growth and retinal damage.
Sanofi is currently evaluating SAR402663 in a Phase 1/2 clinical trial (NCT06660667) targeting patients with neovascular, or “wet,” AMD—a severe form of the disease that affects over one million people in the U.S. and six million worldwide. The therapy hopes to significantly reduce the treatment burden by eliminating the need for frequent injections, which are the current standard of care.
AMD is a progressive retinal disease impacting roughly 200 million people globally. Neovascular AMD leads to vision loss and can severely impact quality of life by limiting everyday activities such as reading and driving. The FDA’s fast track designation is intended to speed the development and review of SAR402663, potentially bringing this innovative treatment to patients sooner.