TUESDAY, June 6, 2023 (HealthDay News) -- Low-dose atropine treatment reduces pediatric myopia progression compared with placebo over three years of treatment, according to a study published online June 1 in JAMA Ophthalmology.
Karla Zadnik, O.D., Ph.D., from The Ohio State University in Columbus, and colleagues assessed the safety and efficacy of NVK002, a novel, preservative-free, once-daily 0.01 percent and 0.02 percent low-dose atropine formulation for treating myopia progression versus placebo. The analysis included 573 randomly assigned pediatric participants (aged 3 to 10 years in the safety group, of whom 489 children aged 6 to 10 years were in the modified intention-to-treat group), from 23 sites in North America and five countries in Europe. Participants had −0.50 diopter (D) to −6.00 D spherical equivalent refractive error (SER) and no worse than −1.50 D astigmatism.
The researchers found that compared with placebo, low-dose atropine (0.01 percent) significantly increased the responder proportion (odds ratio, 4.54; 95 percent confidence interval, 1.15 to 17.97; P = 0.03), slowed mean SER progression (least squares mean [LSM] difference, 0.24 D), and slowed axial elongation (LSM difference, −0.13 mm) at the three-year mark. While 0.02 percent dosage also showed benefit, it was not associated with a significant increase in the responder proportion (odds ratio, 1.77; 95 percent confidence interval, 0.50 to 6.26; P = 0.37) nor slowed mean SER progression (LSM difference, 0.10 D), but it did slow mean axial elongation (LSM difference, −0.08 mm). Atropine was not associated with any serious ocular adverse events.
"Trial results show that the efficacy and safety observed may be supportive of a pharmacological treatment option for myopia progression in children," the authors write.
Several authors disclosed ties to ophthalmic-biopharmaceutical companies, including Vyluma, which manufactures NVK002 and funded the study.