SAR402663 earns fast track designation for treatment of nAMD

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Sanofi announced the US Food and Drug Administration (FDA) granted fast track designation to its gene therapy candidate, SAR402663.¹ SAR402663 is an investigational one-time intravitreal gene therapy for the treatment of neovascular age-related macular degeneration (nAMD).

SAR402663, which delivers genetic material encoding soluble FLT01 designed to inhibit VEGF, is currently being investigated in a phase 1/2 clinical study (NCT06660667).¹ The investigational drug aims to address the underlying disease pathology of nAMD by inhibiting abnormal blood vessel growth, reducing vascular leakage, and minimizing retina damage.¹

The phase 1/2 multicenter study is currently recruiting patients aged 50 to 90 years with nAMD currently receiving anti-VEGF treatment and who have shown a response to aflibercept.²

Participants will be enrolled in one of two parts: part 1 will look at dose escalation, in which multiple dose levels of SAR402663 will be evaluated in successive cohorts; part 2 will look at dose expansion, in which participants will be randomized to receive one of two dose levels selected based on part 1 data.³

The 12-month study will involve participants receiving a one-time intravitreal injection followed by regular assessments for one year to monitor safety and effectiveness. After the one-year follow-up, participants will receive long-term follow-up for up to 5 years.²

The fast-track designation process was created by the FDA to help deliver important new drugs to market earlier, aiming to facilitate the development and expedition of the review of medicines to treat conditions and reach unmet needs.¹

Reference:

1. Press Release: Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration. Sanofi.com. Published 2025. Accessed September 11, 2025. https://www.sanofi.com/en/media-room/press-releases/2025/2025-09-11-05-00-00-3148313

2. A Safety and Efficacy Study of One-time SAR402663 | Clinical Research Studies Listing. Sanofistudies.com. Published 2025. Accessed September 11, 2025. https://www.sanofistudies.com/us/en/listing/312991/a-safety-and-efficacy/

3. Clinicaltrials.gov. Published 2025. Accessed September 11, 2025. https://clinicaltrials.gov/study/NCT06660667?term=SAR402663&rank=1