FDA Grants Fast Track Designation to Sanofi’s Investigational Gene Therapy for Wet AMD

The FDA has granted fast track designation to Sanofi's SAR402663, an investigational one-time intravitreal gene therapy for the treatment of neovascular (wet) age-related macular degeneration (AMD).

The FDA’s fast track process is designed to facilitate development and expedite review of medicines for serious conditions with unmet medical needs, enabling patients to access important new therapies sooner.

SAR402663 delivers genetic material encoding soluble FLT01, a protein designed to inhibit vascular endothelial growth factor (VEGF). By targeting the underlying disease pathology, this gene therapy aims to:

• Prevent abnormal choroidal neovascularization

• Reduce vascular leakage and retinal damage

• Significantly decrease treatment burden by potentially eliminating the need for frequent intravitreal anti-VEGF injections

Sanofi is currently evaluating SAR402663 in a phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT06660667) to assess safety, tolerability, and preliminary efficacy.

According to Sanofi, if successful, this single-dose intravitreal gene therapy could provide long-term VEGF suppression, reducing or even eliminating the need for monthly anti-VEGF injections.