French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Thursday that it has received fast track designation from the US Food and Drug Administration (FDA) for SAR402663, an investigational one-time intravitreal gene therapy targeting neovascular or "wet" age-related macular degeneration (AMD).

This designation is intended to accelerate development and review of therapies addressing serious conditions with unmet medical need.

SAR402663 delivers genetic material encoding soluble FLT01 to inhibit vascular endothelial growth factor, aiming to reduce abnormal blood vessel growth, vascular leakage, and retinal damage. Currently in a phase 1/2 clinical trial, the therapy is designed to significantly reduce treatment burden by eliminating frequent intravitreal injections.

Wet AMD affects more than one million people in the US and six million globally, causing vision loss and impacting daily activities such as reading and driving. The gene therapy represents a potential one-time treatment for a condition that currently requires repeated interventions.