Workflow
Press Release: Sanofi's SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration
SanofiSanofi(US:SNY) Globenewswireยท2025-09-11 05:00

Core Insights - The FDA has granted fast track designation to Sanofi's SAR402663, a one-time intravitreal gene therapy for neovascular age-related macular degeneration (AMD) [1][7] - This designation aims to expedite the development and review of treatments for serious conditions, addressing unmet medical needs [1] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, with a commitment to addressing urgent healthcare challenges [5] - The company is exploring therapies for various neurological diseases, including AMD, and aims to leverage scientific innovation in ophthalmology for growth [4] Product Details - SAR402663 delivers genetic material that encodes soluble FLT01, designed to inhibit vascular endothelial growth factor (VEGF), addressing the underlying pathology of neovascular AMD [2] - The therapy aims to reduce treatment burden by eliminating the need for frequent intravitreal injections, which is a significant advantage for patients [2][7] Market Context - Neovascular AMD affects over one million people in the US and approximately six million people worldwide, significantly impacting quality of life [3] - The condition is characterized by abnormal blood vessel growth beneath the retina, leading to vision loss and potential blindness [3]