Sydnexis, Inc. announced topline results from the phase 3 STAR (Study of Atropine for the Reduction of Myopia Progression) trial of SYD-101, the company's  proprietary 0.01% atropine formulation developed to slow the progression of myopia in children. These findings were recently presented in a poster session at the Academy of Managed Care Pharmacy (AMCP) Nexus 2025, in National Harbor, Maryland.

According to a company press release,SYD-101 0.01% met its primary efficacy endpoint of proportion of patients with confirmed progression of -0.75 D at 36 months vs vehicle [139 vs 111 patients (Vehicle vs. 0.01%); p=0.0226]  in the full study population. Additionally, SYD-101 0.01% met its key secondary endpoint, mean myopic annual progression rate, in the full study population at month 36 (Vehicle: -0.38 D/year vs 0.01% -0.30 D/year [p=0.0002]).

Data presented at AMCP also showed that the magnitude of clinical effect of change in spherical equivalent was larger in younger patients (ages 3-12 at treatment initiation), with both doses demonstrating nominal statistical significance. [Vehicle ‑1.07 D; 0.01% -0.77 D (p-0.0002); 0.03% 0.85 D (p=0.0065)].

According to the company, the phase 3 STAR trial is the largest global clinical program completed to date in pediatric myopia. It evaluated a broad population of 847 children ages 3-14 at treatment initiation. Participants with myopia -0.50 D to ‑6.00 D with a mean baseline progression of -2.65 D were enrolled across the United States and Europe, and randomized (1:1:1) to vehicle (placebo), SYD-101 0.01%, or SYD-101 0.03%. The study’s primary efficacy endpoint was proportion of patients with confirmed progression of -0.75 D, an endpoint proposed by the US Food and Drug Administration (FDA), and a key secondary endpoint was annual progression rate. Additionally, SYD-101 was well tolerated with no unexpected atropine-related adverse events. 

SYD-101 is currently approved in the European Union, where it is licensed to Santen S.A. and marketed as Ryjunea.