Sydnexis Receives Complete Response Letter from FDA for SYD-101 to Slow Pediatric Myopia Progression

FDA does not approve SYD-101 for slowing pediatric myopia

The FDA did not approve SYD-101, a low-dose atropine formulation that would have been the first pharmaceutical treatment for slowing the progression of pediatric myopia in the U.S., in a complete response letter to manufacturer Sydnexis. SYD-101 is a 0.01% atropine formulation that is designed for “enhanced ocular tissue permeability” and stable at room temperature for up to 3

Sydnexis Receives Complete Response Letter from FDA for SYD-101 to Slow Pediatric Myopia Progression

DEL MAR, Calif.--(BUSINESS WIRE)--Oct 23, 2025-

FDA Cites Insufficient Data for SYD-101, Potential Therapy to Slow Pediatric Myopia Progression

If approved, SYD-101 would have been the first FDA-approved treatment for pediatric myopia, offering hope to millions of affected children in the US.

FDA issues CRL for SYD-101 to treat progression of pediatric myopia

The FDA acknowledged that the primary endpoint was met but that "data do not support the effectiveness of low-dose atropine in children with myopia," according to Sydnexis.

FDA rejects Sydnexis’ myopia drug for kids; Chugai to buy Renalys for $98M upfront

Plus, news about Kura Oncology, X4 Pharmaceuticals, Coya Therapeutics, Harbour BioMed and Silver Creek: 👁️ FDA rejects Sydnexis’ experimental myopia drug: The company said the regulator does not believe the data ...

FDA Does Not Approve Sydnexis’ SYD-101 in Pediatric Myopia

The FDA has issued a complete response letter (CRL) for Sydnexis' new drug application (NDA) for SYD-101, a proprietary 0.01% atropine formulation designed to slow the progression of myopia in children. The NDA for SYD-101 was supported by data from the phase 3 STAR (Study of Atropine for the Reduction of Myopia Progression) trial, which the company's calls the largest global clinical study ever conducted in pediatric myopia. The trial enrolled …