Novel digital therapy for amblyopia demonstrates positive phase 3 results
Luminopia One, an investigational digital therapy that allows patients with amblyopia to watch visually modified TV shows and movies to improve vision, has shown positive results, according to a press release from Luminopia.
The phase 3 multicenter, randomized, controlled pivotal clinical trial, published in Ophthalmology, was designed to test the safety and efficacy of Luminopia One in patients with amblyopia aged 4 to 7 years. The trial included 105 patients, with 51 randomly assigned to the treatment group and 54 to the placebo group.
At 12 weeks, 45 patients in the treatment group had a 1.8-line improvement in best corrected visual acuity in the weak eye compared with a 0.8-line improvement in BCVA in the control group.
In addition, the study demonstrated the proportion of participants who improved 2 lines or more in BCVA in the weak eye at 12 weeks was greater in the treatment group (62%) compared with the control group (33%) (P = .006). Eighty-four percent of patients in the treatment group had a history of patching or atropine treatment, but the efficacy of the digital treatment was “robust” in this subgroup, the release said. There were no serious adverse events reported.
“This study is the first randomized controlled trial to demonstrate efficacy of a novel, binocular approach for treating this neuro-visual condition in children,” Scott Xiao, CEO of Luminopia, said in the release. “We are excited about the potential to provide a new treatment option for millions of children with amblyopia around the world. We are also proud to be redefining what it means to receive treatment, by developing a product that allows patients to watch TV as therapy.”
The FDA is evaluating the results for de novo premarket approval, the release said.