Luminopia, a digital therapeutics company, has announced that the U.S. Food and Drug Administration (FDA) has granted de novo premarket approval for Luminopia One as a prescription therapy to improve vision in children with amblyopia (lazy eye). Luminopia One is meant to enhance visual acuity in children with amblyopia, the leading cause of vision loss in children aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions as prescribed by a trained eye-care professional. Luminopia One allows patients to watch therapeutically modified TV shows and movies to improve their vision within a virtual reality (VR) headset. This digital therapeutic is the first FDA-approved digital therapeutic for children with amblyopia, and more broadly, the first for a neuro-visual disorder.
Amblyopia, a condition that affects 3% of all children, develops when the brain and the eyes stop working together correctly, causing the brain to rely more heavily on one eye over the other and leading to worse vision in the weaker eye. Treating amblyopia with glasses combined with eye-patching or blurring (atropine) eye drops prevents usage of the stronger eye and force usage of the weaker eye. Still, these approaches do not train the eyes to work together. Poor patient compliance and social stigmas also present significant challenges with these existing treatment options.
Luminopia One works by modifying popular TV shows and movies into therapeutic visual stimuli within a VR headset. Luminopia uses a neuroscience-based approach by offering TV and movie content differently to each eye within a kid-friendly virtual reality (VR) headset. Thanks to robust neural plasticity, this rebalancing approach strengthens visual processing, promotes weaker eye usage, and encourages both eyes to work together correctly.
To develop a new digital therapeutic approach for patients, Luminopia partnered with leading clinicians and researchers at Boston Children’s Hospital and the Picower Institute for Learning and Memory at MIT and beloved media companies like Sesame Workshop, Nelvana, and Millimages. With Luminopia One, patients can choose videos to watch from a selection of 700+ hours of popular, engaging, and educational content. Proprietary algorithms modify the selected videos in real-time within a VR headset to promote weaker eye usage and encourage patients’ brains to combine input from both eyes.
The Luminopia organization expects to launch Luminopia One in the second quarter of 2022. Eye care professionals will prescribe the therapeutic for 1 hour per day, six days per week, for 12-week periods, and used at home by patients. Luminopia engages with regional and national payers throughout the U.S. to pursue coverage for the therapeutic as a pharmacy benefit to ensure access for children and families in need of new amblyopia therapies.
Luminopia One was granted approval based on positive data from multiple clinical trials, including a phase 3 pivotal trial recently published in Ophthalmology, the journal of the American Academy of Ophthalmology, demonstrating the therapeutic’s safety and efficacy in amblyopia patients aged 4-7. This study was the first successful randomized controlled trial of a new amblyopia therapy in more than a decade and the first to show the efficacy of a novel, binocular approach.
Luminopia One is the first FDA-approved digital therapeutic for a neuro-visual disorder in children, indicated to improve vision in children with amblyopia. With Luminopia One, patients choose TV shows and movies to watch from a selection of 700+ hours of popular, engaging, and educational content. Proprietary algorithms modify the selected videos in real-time within a virtual reality (VR) headset to promote weaker eye usage and encourage patients’ brains to combine input from both eyes. Luminopia One has been validated through a series of clinical trials, including a phase 3 pivotal trial that demonstrated its safety and efficacy in children aged 4-7 with amblyopia. Pilot studies have also shown efficacy in older children and adolescents, where eye-patching and blurring (atropine) eye drops are mainly ineffective.