Sanofi’s SAR402663 Receives US Fast Track Designation for Neovascular Age-Related Macular Degeneration
Thursday, September 11, 2025
Sanofi has received Fast Track designation from the US Food and Drug Administration (FDA) for SAR402663, a single-dose intravitreal gene therapy being developed for the treatment of neovascular age-related macular degeneration (AMD).
Neovascular or “wet” AMD is a severe form of macular degeneration that affects over one million people in the United States and more than six million worldwide. It is caused by the growth of abnormal blood vessels beneath the retina, which can lead to vision loss and blindness in advanced stages. AMD overall impacts around 200 million people globally, severely affecting quality of life and daily activities such as reading and driving.
The designation is designed to speed up the development and review of therapies for serious conditions with unmet medical needs.
SAR402663 delivers genetic material encoding soluble FLT01 to inhibit vascular endothelial growth factor (VEGF). This approach aims to block the growth of abnormal blood vessels, reduce vascular leakage, and limit retinal damage, while potentially lowering the treatment burden by reducing the need for frequent intravitreal injections. The therapy is currently being studied in a Phase I/II clinical trial (NCT06660667).
It continues to advance research in neurology and ophthalmology, focusing on neuroinflammatory and neurodegenerative conditions including multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, Alzheimer’s disease, Parkinson’s disease, and AMD.
The company is also exploring new treatment approaches for retinal diseases where current therapies remain limited.
Source: globenewswire.com
