Previously approved1 for children aged 4 to 7 years, Luminopia's innovative amblyopia treatment is backed by multiple clinical trials and real-world evidence and is now cleared for a wider patient population
CAMBRIDGE, Mass., April 22, 2025 /PRNewswire/ -- Luminopia, Inc., a digital health company pioneering a new class of treatments for neuro-visual disorders, today announced that the U.S. Food & Drug Administration (FDA) cleared its amblyopia treatment for patients aged 8 to 12 years, expanding its existing label from patients 4 to 7 years old to patients 4 to <13 years old with amblyopia associated with anisometropia and/or mild strabismus. This opens the door to a new treatment option for about 400,000 8- to 12-year-olds in the U.S. suffering from amblyopia and marks the first FDA clearance for an amblyopia treatment for this age range in more than two decades.
The FDA's decision was based on Luminopia's robust database of Real-World Evidence (RWE), generated through its Patients Using Prescription Luminopia (PUPiL) Registry™ (NCT06429280). The largest amblyopia treatment registry to-date, the PUPiL Registry uses an all-comers' design to evaluate real-world outcomes in a representative population. It's comprised of more than 500 patients and counting, from 45 prescribers at 14 academic and community centers including Boston Children's Hospital, Children's Hospital of Philadelphia, Lurie Children's Hospital of Chicago, UCSF Benioff Children's Hospitals and The Johns Hopkins Wilmer Eye Institute. The PUPiL Registry, combined with data from Luminopia's Phase 1, 2 and 3 clinical trials, make Luminopia the most thoroughly studied digital treatment for amblyopia.
The FDA determined that Luminopia's safety and efficacy in patients aged 8 to 12 years is substantially equivalent to its safety and efficacy in patients aged 4 to 7 years. Additionally, patients in Luminopia's PUPiL Registry were treated with traditional therapies for an average of 1.8 years prior to switching to Luminopia and they were still able to gain an additional line of vision.
"It's rare for the FDA to provide clearance based on RWE alone and, as far as we're aware, this is the first instance of it being done in ophthalmology. The FDA's decision is a testament to the rigorous design of the PUPiL Registry and the strength of our product's safety and efficacy," said Scott Xiao, Luminopia's Co-Founder and CEO. "We're proud to offer a new treatment option for 8- to 12-year-old amblyopia patients, addressing the unmet need for effective therapies as the efficacy of traditional approaches like eye-patching is known to decline significantly after age 8."
Amblyopia, commonly known as lazy eye, is the leading cause of vision loss in children and statistically affects about one child in every classroom. Luminopia works differently than traditional therapies, such as eye-patching and atropine eye drops, by taking a unique, binocular approach to treating amblyopia. Luminopia allows patients to watch their favorite TV shows through an immersive VR headset for one hour a day, six days a week and overlays therapeutic algorithms that engage both eyes to treat the condition. With access to 75 carefully curated, kid-friendly shows like Sesame Street and SpongeBob SquarePants, Luminopia encourages patient engagement and can lead to significantly improved vision at 12 weeks as demonstrated in clinical studies – even in patients who have been previously treated with traditional therapies.
"Luminopia is the only treatment for amblyopia that has demonstrated comparable efficacy in young children and pre-teens," said Robert Gold, M.D., F.A.A.P., a pediatric ophthalmologist with Eye Physicians of Central Florida and Past-President of the American Association for Pediatric Ophthalmology and Strabismus (AAPOS). "I look forward to offering this innovative treatment option to my 8- to 12-year-old patients, including those who have tried other therapies that didn't work for them."
Luminopia can be prescribed by eye care professionals today through CoAssist Pharmacy. For more information, visit www.luminopia.com.
About Luminopia, Inc.
Luminopia, Inc. 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. The company is an Innovation Partner of Boston Children's Hospital and developed its lead product to improve vision in children with amblyopia, the leading cause of vision loss among children. For more information, visit luminopia.com.
About Luminopia
Luminopia is the first FDA-approved¹ digital therapeutic for a neuro-visual disorder, indicated to improve vision in children with amblyopia. With Luminopia, patients choose TV shows and movies to watch from a selection of 1100+ hours of popular, engaging and educational content. Dual-acting 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. Unlike conventional treatments like eye-patching, blurring (atropine) eye drops and other digital therapies, which just penalize the stronger eye, Luminopia teaches patients to use both eyes together in a unique, binocular manner.
Luminopia has been cleared by the FDA for children aged 4 to <13 years and validated through a series of clinical trials as well as a real-world registry. The Phase 3 pivotal trial was the first successful, randomized, controlled trial of a novel amblyopia treatment in almost 15 years, and the results were published in Ophthalmology, leading to the initial FDA approval for patients aged 4 to 7 years. Based on the robust real-world evidence collected through the PUPiL Registry, the FDA determined that Luminopia's safety and efficacy in patients aged 8 to 12 years is substantially equivalent to its safety and efficacy in patients aged 4 to 7 years, leading to a subsequent label expansion clearance.
For more information, visit luminopia.com.
¹De Novo granted in Oct 2021, 510(k) clearance in Apr 2025 to expand the age range.
Indications for Use for Luminopia
Luminopia 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 is indicated for improvement in visual acuity in amblyopia patients, aged 4 to <13, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia is intended for both previously treated and untreated patients. Luminopia 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 therapy. Luminopia is intended for prescription use only, in an at-home environment.
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SOURCE Luminopia
