Sanofi has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to its investigational gene therapy, SAR402663, for the treatment of neovascular (wet) age-related macular degeneration (AMD).The therapy is a one-time intravitreal gene therapy designed to deliver genetic material encoding soluble FLT01, an inhibitor of vascular endothelial growth factor (VEGF). By reducing VEGF activity, SAR402663 aims to slow abnormal blood vessel growth, decrease vascular leakage, and limit retinal damage associated with wet AMD.
SAR402663 is currently being assessed in a Phase 1/2 clinical trial (NCT06660667). The investigational therapy could reduce the treatment burden for patients by minimising the need for frequent intravitreal injections, which are the current standard of care.
Age-related macular degeneration is a progressive eye disease affecting the retina. The neovascular (wet) form is the leading cause of vision loss in people over 60, affecting more than one million people in the US and around six million worldwide.
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