Sydnexis Pediatric Myopia Drug Meets Endpoints

Sydnexis says its SYD-101, a proprietary 0.01% atropine formulation developed with enhanced ocular delivery characteristics and room-temperature stability to slow the progression of myopia in children, met both the primary and key secondary endpoints in the Phase 3 STAR trial. A company statement says treatment effects were evident by month 12 and sustained through month 36, with the greatest treatment benefit observed in younger children, in trial participants with a history of myopia progression, or when administered earlier in progression.

Sydnexis says STAR evaluated 847 children aged 3-14 at treatment initiation. The primary efficacy endpoint was the proportion of patients with confirmed progression of -0.75 diopters, an endpoint proposed by FDA, and a key secondary endpoint was the annual progression rate. It says SYD-101 met both the primary and key secondary endpoints and was well tolerated, with no unexpected atropine-related adverse events.