Sydnexis Announces FDA Advisory Committee Meeting to Review NDA for SYD-101 for Pediatric Progressive Myopia
The U.S. Food and Drug Administration (FDA) has informed the Company of its intent to convene an Advisory Committee meeting to discuss SYD-101, an investigational low-dose atropine therapy for the treatment of PPM. While the date for the meeting has not been set, the FDA has indicated that the Advisory Committee will be asked to discuss various aspects of the Company’s application, including findings from the Phase 3 STAR study. Sydnexis submitted a Formal Dispute Resolution Request (FDRR) to the FDA’s Office of Specialty Medicine (OSM) after receiving a Complete Response Letter (CRL) in October of 2025.