French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) said on Wednesday that the US Food and Drug Administration (FDA) has granted fast track designation to SAR446597, a one-time intravitreal gene therapy for geographic atrophy caused by age-related macular degeneration (AMD).

This designation is intended to accelerate development and review of treatments for serious conditions with unmet medical needs.

SAR446597 is designed to inhibit two critical components of the complement cascade -- C1s and factor Bb -- via sustained expression of therapeutic antibody fragments. This approach may offer clinical advantages by reducing the need for frequent intravitreal injections while providing long-term suppression of retinal inflammation.

Sanofi plans to initiate a phase 1/2 study to evaluate the safety, tolerability and efficacy of SAR446597.

Geographic atrophy, an advanced form of dry age-related macular degeneration, leads to irreversible vision loss and affects over 5 million people globally.

Sanofi is also conducting a phase 1/2 trial of SAR402663, a separate one-time intravitreal gene therapy targeting neovascular wet age-related macular degeneration.