The US Food and Drug Administration (FDA) has granted fast track designation to Sanofi’s SAR402663, an investigational gene therapy for neovascular age-related macular degeneration (nAMD). The designation is intended to speed development of treatments for serious conditions where current options are limited.
SAR402663 is a one-time intravitreal injection that delivers genetic material encoding soluble FLT01, which is designed to inhibit vascular endothelial growth factor (VEGF). Sanofi is evaluating the therapy in a phase 1/2 study.