Posted by Michael Wonder on 24 Oct 2025
Sydnexis receives complete response letter from FDA for SYD-101 to slow paediatric myopia progression
23 October 2025 - Sydnexis, today announced that the US FDA has issued a complete response letter for the new drug application for SYD-101, a proprietary 0.01% atropine formulation developed with enhanced ocular delivery characteristics and room-temperature stability to slow the progression of paediatric myopia in children.
Sydnexis’ NDA for SYD-101 was supported by the results of the Phase 3 STAR (Study of Atropine for the Reduction of Myopia Progression) trial, the largest global clinical program completed to date in paediatric myopia, which evaluated more than 800 children aged 3-14 at treatment initiation.
