Sydnexis, Inc. | MedPath

FDA Accepts NDA for Sydnexis' SYD-101: First Potential Pharmaceutical Treatment for Pediatric Myopia

2 months ago

• The FDA has accepted Sydnexis' New Drug Application for SYD-101, a low-dose atropine eye drop for pediatric myopia management, with a target action date of October 23, 2025. • If approved, SYD-101 would become the first and only FDA-approved pharmaceutical option for treating progressive myopia in children in the United States, addressing a condition expected to affect 50% of the global population by 2025. • The NDA is supported by the landmark STAR study, a 3-year Phase 3 clinical trial that enrolled 852 pediatric patients aged 3-14 years, making it the largest clinical study ever completed for pediatric myopia progression.