September 12, 2025
1 min read
Key takeaways:
- SAR402663 is a one-time intravitreal gene therapy designed to reduce treatment burden.
- It is currently being investigated in a phase 1/2 trial.
Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA granted fast track designation to SAR402663, an intravitreal gene therapy for the treatment of wet age-related macular degeneration, according to a press release from Sanofi.
SAR402663 is currently being investigated in a phase 1/2 trial.
The gene therapy is designed to inhibit abnormal blood vessel growth, reduce vascular leakage and minimize retina damage by delivering genetic material encoding soluble FLT01 to inhibit VEGF in patients with wet AMD. It is a one-time intravitreal therapy aimed at eliminating the burden of frequent injections.
The FDA grants fast track designation to expedite the development and review of medicines that treat serious conditions and address unmet medical needs. SAR402663 is currently being investigated in a phase 1/2 trial, according to the release.
As Healio previously reported, Sanofi’s intravitreal gene therapy for geographic atrophy due to AMD received fast track designation in July.
