FDA Fast Tracks Gene Therapy for Wet AMD
- * 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).
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.
