Key Highlights
- FDA grants Fast Track Designation to Sanofi’s SAR402663, an investigational one-time intravitreal gene therapy for neovascular (wet) AMD.
- Designed to deliver soluble FLT01 and inhibit abnormal blood vessel growth, SAR402663 aims to eliminate frequent intravitreal injections.
- Currently in Phase 1/2 trials (NCT06660667), the therapy could reshape care for over one million patients in the US affected by wet AMD.
A Major Step Forward in Retinal Disease Innovation
The FDA’s Fast Track designation underscores the urgent need for new therapies in neovascular AMD, a severe condition that leads to progressive vision loss and affects millions worldwide. By expediting the review process, the designation accelerates SAR402663’s path toward potential regulatory approval.
Novel Gene Therapy Targeting VEGF Pathway
SAR402663 works by delivering genetic material encoding soluble FLT01, a protein designed to inhibit vascular endothelial growth factor (VEGF). By blocking abnormal vessel growth and vascular leakage beneath the retina, the therapy aims to preserve vision and reduce long-term damage to retinal tissues.
Reducing Treatment Burden for Patients
Current treatments for wet AMD often require regular intravitreal injections, creating significant patient and caregiver burden. Sanofi’s one-time approach could represent a paradigm shift—offering sustained efficacy with a single administration, while maintaining or improving quality of life for patients.
Sanofi’s Expanding Focus in Neurology & Ophthalmology
This development reflects Sanofi’s strategic focus on neuroinflammatory, neurodegenerative, and ophthalmic diseases. By advancing next-generation therapies in retinal disease, alongside ongoing research in MS, Alzheimer’s, and Parkinson’s, Sanofi is positioning itself at the forefront of neuroscience-driven biopharma innovation.
About Sanofi
Sanofi is an R&D-driven, AI-powered global biopharma company focused on improving lives through transformative medicines and vaccines. With deep expertise in immunology and neurology, Sanofi is pioneering therapies that aim to address unmet needs across serious diseases while integrating cutting-edge digital and AI capabilities to accelerate innovation.
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