FDA Acceptance of New Drug Application for SYD-101 for the Treatment of Progression of Pediatric Myopia

发布时间： 2025-03-17 阅读：21次

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On March 12, 2025, Sydnexis 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 October 23, 2025. If approved, SYD-101 would be the first and only pharmaceutical option for the treatment of progression of pediatric myopia in the United States.

The NDA application is based on three-year primary and secondary endpoints from the STAR Study, Sydnexis’ pivotal 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.

SYD-101 is an investigational low-concentration atropine sulfate ophthalmic solution developed to deliver therapeutic efficacy in pediatric myopia control, while improving pharmaceutical stability and minimizing ocular irritation to enhance treatment compliance. Unlike conventional formulations, SYD-101 achieves an extended shelf-life of up to three years at room temperature without requiring pH adjustment.