Sydnexis Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for SYD-101 and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of Oct. 23, 2025. If approved, SYD-101 would be the first and only pharmaceutical option for the treatment of progression of pediatric myopia in the US.

The NDA application is based on three-year primary and secondary endpoints from the STAR Study, Sydnexis’ Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow the progression of pediatric myopia and the risk of associated co-morbidities.