Low-dose atropine eye drops modestly slowed the progression of myopia in children according to a randomized placebo-controlled trial published in The BMJ. The findings add to growing evidence supporting low-dose atropine as an adjunct to optical interventions for myopia control.

Researchers led by Augusto Azuara-Blanco, MD, from the Centre for Public Health, Queen’s  University Belfast, Belfast, Northern Ireland, found that atropine significantly slowed both refractive progression and axial eye growth compared with placebo.

Myopia is becoming increasingly common in children. In Germany, approximately 15% of children are myopic by the end of elementary school, and the prevalence has steadily increased in recent years. Spending less time outdoors and more time on near-vision activities, such as reading, using smartphones, or viewing screens, has been associated with an increased risk for myopia.

Since June 2025, the EU has approved atropine sulfate 0.01% eye drops for children aged 3-14 years with myopia between -0.5 diopter (D) and -6.0 D. The treatment is intended for once-nightly administration in both eyes for at least 2 years.

Clinical Evidence

The approval was supported by an unpublished study cited by the European Medicines Agency, in which 852 children whose myopia had progressed by at least 0.5 D annually were followed for 2 years. Over the study period, myopia progression was 0.54 D vs 0.34 D in the placebo group vs the atropine group.

In Germany, treatment is reimbursed by statutory health insurance. However, it has not yet been adopted by the UK’s National Health Service (NHS). To provide additional evidence for policymakers, Azuara-Blanco and colleagues conducted the current randomized placebo-controlled trial, which largely confirmed earlier findings. Although the treatment effect was modest, it was clinically meaningful.

Trial Findings

Researchers enrolled 289 children aged 6-12 years with myopia ranging from -0.5 D to -10 D at five NHS centers between June 2019 and February 2022. Participants had a mean age of 9.3 years, a mean refractive error of -2.87, and 56% were girls.

Participants were randomly assigned in a 2:1 ratio to receive either 0.01% atropine or placebo. Children in the atropine group received one drop in each eye every evening for 2 years, whereas those in the placebo group received matching placebo drops. All participants wore spectacles to correct myopia.

Researchers assessed refractive progression, axial eye growth, safety, and tolerability at 6-month intervals. Overall, 235 children completed the study, and efficacy data were available for 230 participants, including 151 vs 79 in the atropine group vs the placebo group.

Atropine significantly slowed myopia progression compared with placebo in both primary outcomes: refractive error and central axial length of the eye. The adjusted between-group difference was 0.38 D for refractive error and 0.14 mm for axial eye length. The treatment effect was consistent across subgroups defined by age, sex, and baseline visual acuity. The researchers did not collect data on lifestyle habits, such as screen time or time spent outdoors.

Safety Profile

The only significant difference in secondary outcomes was pupil diameter, which was, on average, 0.36 mm larger in the atropine group, consistent with the expected pharmacologic effect of atropine. The frequency of adverse events, including ocular itching, blurred vision, and difficulty in reading or writing, was similar in both the groups.

The researchers acknowledged several limitations, including uncertainty about whether the findings would translate to routine clinical practice and the potential influence of the COVID pandemic during the study period. Nevertheless, they concluded that low-dose atropine eye drops represent a useful addition to existing optical interventions for childhood myopia in the UK.

Remaining Questions

These findings are likely to renew the discussion of low-dose atropine therapy in Germany, where the preservative-containing formulation Ryjunea has been available for approximately 1 year. Although atropine is the most effective drug for slowing axial elongation of the eyeball, its precise mechanism of action remains unclear.

A higher concentration of atropine eye drops (0.05%) has demonstrated greater efficacy in slowing childhood myopia progression but is also associated with adverse effects, particularly photophobia, blurred vision, and allergic reactions. Evidence also suggests that higher concentrations of atropine eye drops may increase the risk for progression of myopia more rapidly once the eye drops are discontinued. Long-term safety data remain limited for both low- and high-dose atropine eye drops.

This story was translated from Medscape’s German edition.