Real-world data show Luminopia improves visual acuity in children with amblyopia
Click Here to Manage Email Alerts
Digital health company Luminopia Inc. announced real-world data from the Patients Using Prescription Luminopia Registry, which demonstrated the efficacy of its binocular, virtual reality-based medical device for children with amblyopia.
“The analysis of real-world data from the PUPiL registry demonstrates the benefit of digital therapy in improving outcomes for amblyopia,” Derek Sprunger, MD, FAAO, professor at Indiana University School of Medicine, said in a company press release. “Luminopia’s unique mechanism of action, which doesn’t just penalize the strong eye but uses dichoptic masking to encourage binocular fusion, is proving to be effective for a broad range of patients.”
According to the release, Luminopia pairs proprietary therapeutic software with virtual reality headsets and popular children’s TV shows to promote weaker eye usage and encourage the brain to combine input from both eyes. The device has been on the market for more than a year after receiving de novo FDA premarket approval.
Analysis of the PUPiL registry, which included 179 patients from 10 clinical sites who used Luminopia for 12 weeks, showed significant improvement in visual acuity in a broad population, the release stated. The cohort of patients with similar baseline characteristics to Luminopia clinical trial participants improved by 1.7 lines in 12 weeks, with 83% median treatment adherence, similar to trial findings.
In addition, subgroups of patients with varied condition severity, previous treatment, age and type of amblyopia, also demonstrated significant vision improvement after 12 weeks, with no safety events reported.
“For decades, the standard-of-care treatment for amblyopia has been to patch the stronger eye, but the majority of patients who go through patching are still left with the condition,” Scott Xiao, Luminopia co-founder and CEO, said in the release. “Our product can improve outcomes for patients thanks to both our unique mechanism and better patient compliance. This registry data further validates that our therapy is effective, easy for young patients to use and has significant benefit in the real world.”
Read more about
Click Here to Manage Email Alerts