SNY's Gene Therapy Candidate for Eye Disease Gets FDA Fast Track Tag

Core Insights - Sanofi's investigational gene therapy SAR402663 received fast track designation from the FDA for treating neovascular (wet) age-related macular degeneration (AMD) [1][6] Group 1: Fast Track Designation Benefits - Fast track designation aims to expedite the development and review of drugs addressing serious conditions and unmet medical needs, allowing for earlier patient access [2] - The designation enables rolling review, allowing Sanofi to submit completed sections of the regulatory filing for SAR402663 as they become available, potentially speeding up the evaluation process [2][6] Group 2: Product Details - SAR402663 is a one-time intravitreal gene therapy targeting vascular endothelial growth factor (VEGF), which is responsible for abnormal blood vessel growth in the eye [5][6] - The therapy aims to reduce treatment burden by eliminating the need for frequent intravitreal injections [5][6] Group 3: Clinical Development - Sanofi is currently conducting a phase I/II study for SAR402663 in patients with neovascular/wet AMD, a severe condition affecting over a million people in the United States [7] Group 4: Competitive Landscape - Key competitors include AbbVie's ABBV-RGX-314, which is also a one-shot gene therapy targeting VEGF and is in pivotal studies for wet AMD, with data expected next year [8] - Another competitor is 4D Molecular Therapeutics' 4D-150, which is also targeting VEGF and is undergoing late-stage studies for wet AMD, with data anticipated in the second half of 2027 [9]