Low-dose atropine helps control childhood myopia progression

The novel, preservative-free, low-dose atropine formulation NVK002 appears to be beneficial in the treatment of myopia progression in children when compared with placebo, according to the results of a phase III study.

In the study, a total of 576 participants (54.7 percent women) were randomly assigned to treatment with either low-dose atropine (0.01% or 0.02%) or placebo. The participants were 3 to 16 years of age (mean 8.9 years) with −0.50 to −6.00 dioptre (D) spherical equivalent refractive error (SER) and no worse than −1.50 D astigmatism.

The primary endpoint was the proportion of participants’ eyes responding to therapy, defined as <0.50 D myopia progression at 3 years. The mean change from baseline in SER and axial length at month 36 and safety were also evaluated.

Of the participants, 573 (99.5 percent) were included in the safety set and 489 (84.9 percent) were included in the modified intention-to-treat (mITT) set. At month 36, treatment with low-dose atropine 0.01% was associated with a significantly greater proportion of responders (odds ratio [OR], 4.54, 95 percent confidence interval [CI], 1.15–17.97; p=0.03), slowed mean SER progression (least squares mean [LSM] difference, 0.24 D, 95 percent CI, 0.11–0.37; p<0.001), and slowed axial elongation (LSM difference, −0.13 mm, 95 percent CI, −0.19 to −0.07; p<0.001).

Low-dose atropine 0.02% was also beneficial, although the outcomes were not significantly different than that obtained with placebo except for mean axial elongation (LSM difference, −0.08 mm, 95 percent CI, −0.13 to −0.02; p=0.005).

None of the participants had serious ocular adverse events, although there were a few serious nonocular events, none of which were deemed related to atropine.