Sanofi’s SAR402663 Granted Fast Track Designation in the United States for Neovascular Age-Related Macular Degeneration
Thursday, September 11, 2025
The U.S. Food and Drug Administration (FDA) has granted fast-track designation to Sanofi’s SAR402663, a single-dose intravitreal gene therapy being developed for the treatment of neovascular age-related macular degeneration (AMD). The designation is designed to speed up the development and review of medicines for serious conditions with high unmet medical need, helping patients access new treatments more quickly.
SAR402663 works by delivering genetic material encoding soluble FLT01, intended to block vascular endothelial growth factor (VEGF). By doing so, it aims to slow the growth of abnormal blood vessels, reduce vascular leakage, and limit retinal damage. The approach is also expected to ease the treatment burden for patients by reducing the need for frequent intravitreal injections.
Sanofi is currently assessing SAR402663 in a Phase I/II clinical trial (NCT06660667) in patients with neovascular AMD.
AMD is a progressive retinal disease affecting nearly 200 million people worldwide. The neovascular or “wet” form is the most severe, marked by abnormal blood vessel growth under the retina that can cause vision loss and, in advanced cases, blindness. It affects over one million people in the United States and more than six million globally, with significant impact on daily activities such as reading and driving.
Source: globenewswire.com
