CAMBRIDGE, Mass.—Luminopia, a digital therapeutics company, announced that the U.S. Food and Drug Administration (FDA) has granted de novo premarket approval for its Luminopia One software as a prescription therapy to improve vision in children with amblyopia. Luminopia One allows patients to watch therapeutically modified TV shows and movies to improve their vision within a virtual reality (VR) headset. “The FDA approval of a new digital therapy with robust clinical evidence for children affected by amblyopia is a major development," said David G. 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. The idea of prescribing TV shows and movies to treat amblyopia in children instead of eye patches or eye drops is an exciting prospect," he said.
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 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.
“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, based here.
“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. This important milestone also opens the door for us to adapt our technology to create engaging digital therapeutics for other neuro-visual disorders.”
Luminopia expects to launch Luminopia One in the second quarter of 2022, and the therapeutic will be prescribed by eyecare professionals for 1 hour per day, six days per week, for 12-week periods, and used at home by patients. The company said it is engaging 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.