Sydnexis reports positive Phase 3 results for low-dose atropine in pediatric myopia

Sydnexis, Inc announced topline results from its Phase 3 STAR trial of SYD-101, a proprietary low-dose atropine formulation, showing significant reductions in myopia progression in children at AMCP Nexus 2025.

The STAR (Study of Atropine for the Reduction of Myopia Progression) trial, the largest global pediatric myopia study to date, enrolled 847 children aged 3–14 across the U.S. and Europe. Participants were randomized to receive either SYD-101 0.01%, 0.03%, or placebo. SYD-101 0.01% met both the study’s primary endpoint of proportion of patients with confirmed progression of -0.75 diopters at 36 months, and its key secondary endpoint, annual progression rate.

“The data presented at AMCP Nexus 2025 show strong treatment effects in the full study population at 36 months, but in younger patients, the magnitude of effect gets larger,” said Perry Sternberg, CEO of Sydnexis in a press release. “The STAR data demonstrate that younger kids who historically exhibit fast progression… benefit the most from treatment with SYD-101 0.01%.”

Subgroup analyses highlighted even greater benefits in younger children (3–12 years) and in patients with documented fast progression, with reductions of more than 50% in myopia progression in the latter group. SYD-101 was well tolerated, with no unexpected atropine-related adverse events.

Reference
Cheetham JK, et al. A Novel Low-dose Atropine Eye Drop Slows the Progression of Pediatric Myopia: Evidence from the STAR Study. Poster presented at: Academy of Managed Care Pharmacy (AMCP) Nexus 2025 in National Harbor, MD.