Digital therapeutic shows clinically meaningful vision improvement in children with amblyopia

A digital therapeutic (Luminopia One) was found to be safe and effective in children with amblyopia, according to data from a phase 3 pivotal trial published in the journal Ophthalmology.

The investigational digital therapeutic allows patients to watch visually modified TV shows and movies to improve their vision, according to a company press release.

In this randomized controlled trial, 105 children between the ages of 4 and 7 years with amblyopia were randomized to treatment with the therapeutic at-home for 1 hour/day, 6 days/week plus full-time glasses use (n = 51) or continued full-time glasses use alone (n = 54).

The primary efficacy outcome was change in amblyopic eye visual acuity (VA) from baseline at 12 weeks.

In the treatment group and the glasses alone group, amblyopic eye VA improved 1.8 lines and 0.8 lines, respectively, from baseline to 12 weeks.

At a planned interim analysis, the difference between groups was significant and the study was stopped early for success.

“The data from this pivotal trial validate Luminopia One as a safe and effective potential new treatment option for amblyopia in young children,” said Robert Langer, ScD, an Institute Professor at Massachusetts Institute of Technology (MIT), co-founder of Moderna, co-author of the publication and Luminopia Board Director, said in the press release. “These positive data also illustrate the potential of digital therapeutics as a new class of treatments for serious diseases.”

Reference
Xiao S, Angjelli E, Wu HC, et al. Randomized Controlled Trial of a Dichoptic Digital Therapeutic for Amblyopia. Ophthalmol. 2021; DOI:https://doi.org/10.1016/j.ophtha.2021.09.001