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FDA Fast Tracks Gene Therapy for Wet AMD - News Directory 3

FDA Fast Tracks Gene Therapy for Wet AMD

September 14, 2025 Jennifer Chen Health
News Context
At a glance
  • * FDA Fast Track Designation: The FDA has granted Fast Track designation to Sanofi's SAR402663, a one-time intravitreal gene therapy for wet age-related macular degeneration (wet AMD).
Original source: healio.com

Here’s⁣ a summary of the article, broken down into key points:

* FDA Fast Track Designation: The FDA has granted Fast Track designation to Sanofi’s SAR402663, a one-time intravitreal gene therapy for wet age-related macular degeneration (wet AMD).
* ‍ How it Works: The therapy aims to deliver genetic material encoding ⁣soluble FLT01 to inhibit VEGF, thereby reducing abnormal blood vessel growth, vascular leakage, and retinal damage.
* Benefit: It’s designed to eliminate the need for frequent injections currently required for wet AMD treatment.
* Current Status: ‍ SAR402663 is currently in a⁣ Phase 1/2 clinical⁢ trial.
* Previous ⁣Designation: sanofi also received Fast Track ‍designation in July for‍ a similar gene therapy targeting geographic atrophy ⁢ (another⁣ form ⁤of AMD).
* Published By: Occular Surgery News.

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