Clinical trials tracking children receiving low-dose atropine eyedrops for progressive myopia have reported reassuring corneal safety profiles over a three-year period.
A recent investigation following children over a multiyear span provides fresh data on corneal biometry, tracking structural shifts while monitoring for rare ectatic conditions.
Evaluating Corneal Parameters and Ectasia Risk in the Western Australia Atropine Cohort
Researchers in Western Australia evaluated 153 children aged six to 16 years with progressive myopia, assigning participants in a 2:1 ratio to receive either 0.01% atropine eyedrops or a placebo for two years, followed by a one-year washout as detailed in the trial findings published by Nature. Using Scheimpflug imaging at baseline, 24 months, and 36 months, the team measured changes in corneal parameters through linear mixed models to test whether the low-dose formulation alters ectasia risk.
At 24 and 36 months, the treatment group demonstrated significantly lower BAD-D values compared to the placebo group, showing reductions from baseline. However, investigators noted a statistically significant steepening of maximum keratometry in the atropine cohort at 36 months. All other corneal parameters and cylindrical power remained comparable between the two arms.
One child among the 153 participants developed incidental keratoconus during the treatment phase. Study authors concluded that this single occurrence aligns with general population prevalence rates, finding no signal that suggests a treatment-related increase in corneal ectatic changes within the study’s cohort limitations. While the data offer safety reassurance, researchers emphasize that clinicians should remain vigilant for suspicious corneal findings and refer patients accordingly.
Individualized Dosing and the Search for Regulatory Approval in United States Practice
Beyond structural biometry, pediatric eye care specialists stress that managing progressive myopia requires careful attention to functional vision. Speaking at a recent professional symposium, experts highlighted the necessity of tailoring treatment protocols to the individual.
The use of atropine is highly individualized, and it’s not one size for all patients.
Kevin Chan, clinician and symposium speaker, via Optometry Times
Practitioners currently navigating pediatric progressive myopia in the United States operate without an FDA-approved pharmaceutical therapy specifically indicated for the condition, forcing clinics to rely on compounded formulations. That regulatory landscape could soon shift.
An FDA advisory committee is scheduled to review the application for SYD-101, an atropine 0.01% formulation developed by Sydnexis, on October 30, 2026. This upcoming evaluation follows a complete response letter issued in October 2025.
It will also increase the accessibility of the atropine use for a lot of patients, including low-income or less privileged populations.
Kevin Chan, clinician and symposium speaker, via Optometry Times
As the medical community weighs structural trial data against the prospect of federal product approval, questions remain regarding how standardized commercial dosing will integrate with individualized binocular vision assessments in everyday clinical practice.