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.
to pursue coverage for the therapeutic as a pharmacy benefit to ensure access for children and families in need of new amblyopia therapies. Luminopia is engaging with regional and national payers throughout the U.S. The company expects to launch Luminopia One in the second quarter of 2022, and the therapeutic will be prescribed by eye care professionals for 1 hour per day, 6 days per week, for 12-week periods, and used at home by patients.
This important milestone also opens the door for us to adapt our technology to create engaging digital therapeutics for other neuro-visual disorders.” “We would like to thank our partners, advisors, study participants and team members for getting us here, and we are excited to bring Luminopia One to children with amblyopia across the country. “We’re proud to be part of the FDA’s groundbreaking decision today, to approve a first-of-its-kind digital therapeutic that allows patients to watch their favorite TV shows and movies to improve their vision,” said Scott Xiao, chief executive officer of Luminopia. 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. With Luminopia One, patients can choose videos to watch from a selection of 700+ hours of popular, engaging and educational content. To develop a new 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, as well as beloved media companies like Sesame Workshop, Nelvana and Millimages. Poor patient compliance and social stigmas also present significant challenges with these existing treatment options. 1 Amblyopia is conventionally treated with glasses combined with eye-patching or blurring (atropine) eye drops that prevent usage of the stronger eye and force usage of the weaker eye, but these approaches do not train the eyes to work together. “The idea of prescribing TV shows and movies to treat amblyopia in children instead of eye patches or eye drops is an exciting prospect.”Īmblyopia, a condition which affects 3% of all children, develops when the brain and the eyes stop working together properly, causing the brain to rely more heavily on one eye over the other, and leading to worse vision in the weaker eye. Hunter, MD, PhD, Ophthalmologist-in-Chief, Richard Robb Chair in Ophthalmology, Boston Children’s Hospital* and advisor to Luminopia. Amblyopia is one of the most common conditions I manage as a clinician, and patients, parents and physicians often struggle with current therapies,” said David G.
“The FDA approval of a new digital therapy with robust clinical evidence for children affected by amblyopia is a major development. This is the first FDA-approved digital therapeutic for children with amblyopia, and more broadly, the first for a neuro-visual disorder. Luminopia One allows patients to watch therapeutically modified TV shows and movies to improve their vision within a virtual reality (VR) headset. Luminopia One is indicated for improvement in visual acuity in children with amblyopia, aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions as prescribed by a trained eye-care professional. 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), the leading cause of vision loss in children. CAMBRIDGE, Mass.-( BUSINESS WIRE)- Luminopia, a digital therapeutics company, today announced that the U.S.