Sydnexis, Inc.

FDA to Convene Advisory Committee to Review Sydnexis's SYD-101 for Pediatric Progressive Myopia

- The FDA plans to hold an advisory committee meeting to review SYD-101, a low-dose atropine 0.01% formulation for pediatric progressive myopia, following a prior complete response letter rejecting its NDA. - SYD-101 met its phase 3 STAR study primary and secondary endpoints, including significant reduction in myopia progression at 36 months (p = 0.0226), yet the FDA questioned the durability and robustness of the treatment effect. - Sydnexis has requested that practicing pediatric ophthalmologists and optometrists be included on the advisory committee to ensure real-world clinical perspectives are represented. - SYD-101 is already approved in the European Union and United Kingdom under the brand name Ryjunea, while no FDA-approved pharmaceutical currently exists for pediatric progressive myopia in the U.S.