CAMBRIDGE, Mass.--(BUSINESS WIRE)--Luminopia, a digital therapeutics company, today 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), the leading cause of vision loss in children. 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. Luminopia One allows patients to watch therapeutically modified TV shows and movies to improve their vision within a virtual reality (VR) headset. This is the first FDA-approved digital therapeutic for children with amblyopia, and more broadly, the first for a neuro-visual disorder.
“The FDA approval of a new digital therapy with robust clinical evidence for children affected by amblyopia is a major development. 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. Hunter, MD, PhD, Ophthalmologist-in-Chief, Richard Robb Chair in Ophthalmology, Boston Children’s Hospital* and advisor to Luminopia. “The idea of prescribing TV shows and movies to treat amblyopia in children instead of eye patches or eye drops is an exciting prospect.”
Amblyopia, 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. Poor patient compliance and social stigmas also present significant challenges with these existing treatment options.
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. 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. “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.”
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. Luminopia 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.
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 efficacy of a novel, binocular approach.
In this phase 3 trial, 105 children were randomized to either the treatment group, which received Luminopia One plus glasses, or the control group, which received glasses alone. A statistically significant difference in visual acuity improvement between groups was seen as early as 4 weeks. At the 12-week primary endpoint, the weak eye visual acuity of patients in the treatment group improved 1.8 lines on average on a logMAR eye chart, compared to a 0.8-line improvement in the control group. The difference between groups in improvement was significant (p=0.001).
In addition, 62% of patients in the treatment group showed a strong response, defined as a 2-line or greater improvement, versus 33% in the control group. Importantly, 84% of patients in the treatment group had a history of patching or atropine therapy and were still left with amblyopia, and Luminopia One was as effective in this subgroup of patients. Median adherence to the prescribed dosage was 88% over the study period, substantially higher than the 48% adherence seen in similar studies with patching.2
The study was conducted at 21 academic and community sites in the U.S., including the Cleveland Clinic, UCLA Jules Stein Eye Institute, Duke Eye Center, Ann & Robert H. Lurie Children’s Hospital of Chicago, Texas Children’s Hospital and Children’s Hospital of Philadelphia. No serious adverse events were reported.
About Luminopia One
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 largely ineffective3.
Indications for Use for Luminopia One
Luminopia One is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia One is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia One is intended for both previously treated and untreated patients; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. Luminopia One is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia One therapy. Luminopia One is intended for prescription use only, in an at-home environment.
Amblyopia, commonly referred to as lazy eye, is a medical condition characterized by reduced vision that cannot be explained by structural ocular or optic nerve abnormalities alone. Often diagnosed in young children, amblyopia is driven by neurological deficits, which suppress the visual input from the weaker eye, leading to long-term deficits in vision. Amblyopia can be caused by a variety of different factors, including a refractive error such as nearsightedness (myopia), farsightedness (hyperopia) or astigmatism; strabismus, which is when one eye drifts; or rarely, cataracts or cloudiness in the lens. Amblyopia is the most common cause of vision loss in children and affects 3% of children worldwide. Current treatment options of eye-patching and blurring (atropine) eye drops are monocular approaches, which do not train the eyes to work together and are not sufficient in many cases to restore full visual function.5 Poor patient compliance and social stigmas also present significant challenges with these existing treatment options.
Luminopia is pioneering a new class of treatments for significant neuro-visual disorders. Luminopia is committed to creating digital therapeutics that are both rigorously evaluated for FDA approval and genuinely engaging for patients. As an Innovation Partner of Boston Children’s Hospital*, the company is developing its lead product, Luminopia One, to improve vision in children with amblyopia, the leading cause of vision loss among children. For more information, visit luminopia.com.
LUMINOPIA and LUMINOPIA ONE are trademarks of Luminopia, Inc.
*Boston Children’s Hospital holds equity in Luminopia. David Hunter, MD, PhD, Ophthalmologist-in-Chief at Boston Children’s Hospital is an advisor to Luminopia and holds equity.