STudy of Atropine to Reduce (STAR) Myopia Progression in Children: 24-Month Results of a Randomized, Double-Masked, Vehicle-Controlled Trial of Atropine Sulfate 0.01% and 0.03.

INTRODUCTION

Pediatric myopia is rising globally, with high myopia associated with sight-threatening complications later in life. Low-dose atropine has been shown to slow myopia progression, with most studies conducted in Asian populations using compounded formulations. We evaluated the efficacy and safety of atropine sulfate ophthalmic solution at two concentrations for slowing myopia progression in a predominantly white population.

METHODS

STAR was a randomized, double-masked, vehicle-controlled, phase 3 clinical study conducted in Europe and the USA. Children (N = 847) aged 3-14 years with myopia between - 0.50 and - 6.00 diopters (D) were dosed after 1:1:1 randomization to vehicle, atropine sulfate 0.01% or 0.03% once daily before bedtime for 48 months. The primary endpoint was mean annual progression rate (APR) of myopia, measured by cycloplegic autorefraction, through month 24.

RESULTS

Mean APR at 24 months was - 0.44 D/year (vehicle), - 0.31 D/year (atropine sulfate 0.01%), and - 0.32 D/year (atropine sulfate 0.03%), with differences versus vehicle of 0.13 D (95% CI 0.06-0.20; p = 0.0003) and 0.12 D (95% CI 0.05-0.19; p = 0.0009), respectively. In Fast Progressor Subgroup 1 (progression - 0.50 D/year or worse at baseline), differences versus vehicle were 0.21 D (p < 0.0001) for atropine sulfate 0.01% and 0.15 D (p = 0.0023) for atropine sulfate 0.03%. In Fast Progressor Subgroup 2 (progression - 0.75 D/year or worse at baseline), differences versus vehicle were 0.19 D (p = 0.0008) for atropine sulfate 0.01% and 0.11 D (p = 0.0397) for atropine sulfate 0.03%. TEAEs were similar across groups. Photophobia was the most common ocular event (16.7% vehicle, 24.1% atropine sulfate 0.01%, 30.4% atropine sulfate 0.03%). Treatment discontinuation was similar across groups (18.7% vehicle, 19.7% atropine sulfate 0.01%, 18.6% atropine sulfate 0.03%).

CONCLUSION

Atropine sulfate 0.01% and 0.03% effectively slowed myopia progression in children, with greatest efficacy in Fast Progressors Subgroup 1. Both concentrations were well tolerated with manageable side effects, supporting atropine sulfate as a treatment option for pediatric myopia.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03918915.