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This important milestone also opens the door for us to adapt our technology to create engaging digital therapeutics for other neuro-visual disorders.вЂќ вЂњWe 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.

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вЂњWeвЂ™re proud to be part of the FDAвЂ™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,вЂќ 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 patientsвЂ™ 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 ChildrenвЂ™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. вЂњThe idea of prescribing TV shows and movies to treat amblyopia in children instead of eye patches or eye drops is an exciting prospect.вЂќДЄmblyopia, 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.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.

Hunter, MD, PhD, Ophthalmologist-in-Chief, Richard Robb Chair in Ophthalmology, Boston ChildrenвЂ™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,вЂќ said David G. вЂњThe FDA approval of a new digital therapy with robust clinical evidence for children affected by amblyopia is a major development. 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.