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# Sydnexis NDA Accepted for Pediatric Myopia
- URL: https://www.fdaweb.com/sydnexis-nda-accepted-for-pediatric-myopia/
- Published: 2025-03-11T12:00:00.000Z
- Updated: 2026-09-14T14:54:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158804

FDA has accepted for review a Sydnexis NDA for SYD-101 (topical low-dose atropine) for treating progression of pediatric myopia. The agency has set a user fee review action date of 10/23\. The submission is based on three-year primary and secondary endpoints from the STAR Study, showing that the low-dose atropine formulation slows the progression of pediatric myopia and the risk of associated co-morbidities, the company says. Myopia is the most common eye disease in children, affecting about 28 million children in the U.S. alone with prevalence and severity expected to continue climbing due to lifestyle and environmental factors, it adds.