Low-dose atropine shows greatest benefit in younger children with progressive myopia in Phase 3 STAR trial

New subgroup analyses from the Phase 3 STAR trial presented at the 51st Annual Meeting of the American Association for Pediatric Ophthalmology and Strabismus show that SYD-101 0.01%, a low-dose atropine formulation, significantly slowed pediatric myopia progression.

The global Phase 3 STAR trial enrolled 847 children aged 3 to 14 years with myopia ranging from -0.50 D to -6.00 D across the United States and Europe. Participants were randomized to SYD-101 0.01% or vehicle. The study met its primary endpoint of reducing the proportion of patients with myopia progression of -0.75 D or worse at 36 months and its key secondary endpoint of slowing annual progression rate.

Subgroup analyses showed that treatment effects were most pronounced in children aged 3 to 12 years, with reductions in myopia progression of 47.9% at 12 months, 37.6% at 24 months, and 28.0% at 36 months compared with vehicle. In contrast, children aged 13 to 14 years demonstrated minimal progression regardless of treatment.

The greatest benefit was observed in children classified as fast progressors (>0.5 D/year) with mild to moderate baseline myopia (-0.50 D to -3.00 D). In this group, SYD-101 reduced progression by 76.3% at 12 months, 65.1% at 24 months, and 56.9% at 36 months compared with vehicle.

SYD-101 was well tolerated, with no unexpected atropine-related adverse events reported.

Investigators noted that the subgroup findings help clarify which pediatric patients may derive the most benefit from treatment, particularly younger children and those with more rapid progression.

Reference
Rutar T, et al. The study of atropine to reduce (STAR) myopia progression in children: a randomized, double-masked clinical trial of low-dose atropine. Presented at: 51st Annual Meeting of the American Association for Pediatric Ophthalmology and Strabismus; March 21, 2026; Boston, MA.