Luminopia announced the publication of positive Phase 3 pivotal data of its investigational treatment for amblyopia—Luminopia OneTM—in OphthalmologyⓇ, the journal of the American Academy of Ophthalmology. This is the first successful randomized controlled trial of a novel amblyopia treatment in more than a decade, and the results provide strong evidence supporting a potential new therapy for millions of patients. Unlike current treatment options, which can be frustrating and stigmatizing for young children, Luminopia One is an investigational digital therapeutic that allows patients to watch visually modified TV shows and movies to improve their vision.
In this pivotal study, conducted at 21 leading academic and community sites in the U.S., children in the treatment group, who received Luminopia One plus glasses, experienced a statistically significant improvement in Best Corrected Visual Acuity (BCVA; the primary endpoint) compared to those in the control group, who wore glasses alone (difference between groups: 1.0-line, p=0.0011). No serious adverse events were reported. The results are being evaluated by the U.S. Food and Drug Administration (FDA) for de novo premarket approval.
“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, Sc.D., an Institute Professor at Massachusetts Institute of Technology (MIT), co-founder of Moderna, co-author of the publication and Luminopia Board Director. “These positive data also illustrate the potential of digital therapeutics as a new class of treatments for serious diseases.”
Luminopia One, developed in collaboration with leaders from Boston Children’s Hospital and the Picower Institute for Learning and Memory at MIT, is designed to allow children to watch TV shows and movies as treatment. With Luminopia One, patients choose video content they want to watch, and a software application modifies the content in real-time to rebalance visual input to the brain. This unique, binocular approach promotes weaker eye usage and encourages patients’ brains to combine input from both eyes, unlike monocular therapies like patching and atropine.
Luminopia has partnered with leading media companies to offer popular, engaging and educational content for children, from familiar names like Sesame Workshop and Nelvana. Treatment is delivered using commercially available virtual reality (VR) headsets. Upon potential approval by the FDA, Luminopia One will be prescribed by an eye care professional for 1 hour per day, 6 days per week for 12 weeks, and continued treatment may be prescribed depending on each patient’s response to treatment.
“Luminopia’s efforts to rethink treatment for children with amblyopia are very promising. Patching is often ineffective due to poor adherence, as any parent who has tried to patch their child’s eye knows. In addition, current treatment options don't encourage patients to use both eyes together. Luminopia One addresses both of these problems,” said Gil Binenbaum, M.D., MSCE, pediatric ophthalmologist, and advisor to Luminopia. “It is exciting to envision a future where clinicians will be able to prescribe entertaining and educational shows instead of patching to improve children’s vision.”
Read the full press release: https://www.businesswire.com/news/home/20210914005661/en/Luminopia-One-a-Digital-Therapeutic-for-Amblyopia-Demonstrates-Safety-and-Efficacy-in-Phase-3-Pivotal-Trial