Study: Higher-dose atropine more effective in slowing myopia progression in childrenLatest revision | Image Credit: © MIA Studio - © MIA Studio - stock.adobe.com.

A new study published in JAMA Ophthalmology found that 0.05% atropine eye drops were more effective at slowing myopia progression in children compared to 0.01% atropine or placebo, despite a higher incidence of mild visual side effects. The MOSAIC2 randomized clinical trial, which examined different atropine regimens over 3 years, evaluated their impact on refractive error and axial elongation in pediatric patients.

Background

The study investigators, led by James Loughman, Phd, noted myopia has become a significant global public health concern, with increasing prevalence and associated risks of long-term visual impairment. Atropine, a nonselective muscarinic antagonist, has been studied extensively as a pharmacological intervention to slow myopia progression.

"Over the past 2 years, 0.01% atropine eye drops have been investigated in children of European descent, including in the 24-month Myopia Outcome Study of Atropine in Children (MOSAIC) clinical trial results," stated Loughman and colleagues,

While lower concentrations of atropine, such as 0.01%, have been explored for their efficacy and tolerability, uncertainty remains about the optimal dosing strategy, particularly in European pediatric populations.

"This study aimed to explore (1) the change in myopia progression after ceasing 0.01% atropine eye drops or reducing its frequency in a tapering regimen and (2) the safety and efficacy of 0.05% atropine eye drops in a European population of treatment-naive participants," the investigators wrote.

Study Details and Results

The MOSAIC2 trial followed 199 children with myopia (mean age: 13.9 years) who were originally enrolled in the MOSAIC study. Participants were divided into 2 primary groups:

1. Placebo for 2 years, followed by nightly 0.05% atropine for 1 year
2. Nightly 0.01% atropine for 2 years, followed by randomization to 1 of 3 subgroups:

• Continued placebo
• Tapering placebo
• Tapering 0.01% atropine

Compared with the group that received placebo for 2 years before switching to 0.05% atropine, those who received 0.01% atropine followed by placebo had greater myopia progression (adjusted difference: −0.13 diopters [D]; 95% CI, −0.22 to −0.04 D; P = .01) and axial elongation (adjusted difference: 0.06 mm; 95% CI, 0.02-0.09 mm; P = .008). Additionally, the subgroup that tapered 0.01% atropine had more axial elongation than the 0.05% atropine group (adjusted difference: 0.04 mm; 95% CI, 0.009-0.07 mm; P = .04).

Adverse effects were noted primarily in the 0.05% atropine group, with 15% of participants reporting blurred near vision and 8% experiencing photophobia. However, these symptoms were absent in the placebo groups and minimal in the 0.01% atropine-tapering group (3% blurred vision, 0% photophobia). Adverse events did not result in higher discontinuation rates.

Conclusion

The results from the MOSAIC2 trial suggest that while 0.05% atropine was associated with a higher incidence of mild adverse events, it was more effective in controlling myopia progression compared to 0.01% atropine or placebo. Given the need for effective myopia control strategies in pediatric populations, the authors concluded that their findings support the consideration of 0.05% atropine as a treatment option, despite increased risk of minor visual disturbances.

Reference:

Loughman J, Lingham G, Nkansah EK, Kobia-Acquah E, Flitcroft DI. Efficacy and Safety of Different Atropine Regimens for the Treatment of Myopia in Children: Three-Year Results of the MOSAIC Randomized Clinical Trial. JAMA Ophthalmol. Published online January 09, 2025. doi:10.1001/jamaophthalmol.2024.5703