Luminopia Announces That Anthem Blue Cross and Blue Shield Has Approved Its Amblyopia Treatment for Coverage

This will expand access to Luminopia's engaging, evidence-based treatment for children and allow more patients to benefit from its unique approach to treating amblyopia

CAMBRIDGE, Mass., May 8, 2025 /PRNewswire/ -- Luminopia, Inc., a digital health company pioneering a new class of treatments for neuro-visual disorders, today announced that Anthem Blue Cross and Blue Shield has approved its amblyopia treatment for coverage. Patients who meet Anthem's criteria will now have Luminopia covered by their plan. This is a significant step forward in ensuring that more children nationwide can have access to this FDA-cleared treatment option for amblyopia.

Anthem is the second largest health plan in the U.S. and now their members with amblyopia will have the option to watch TV as treatment and benefit from Luminopia's unique, dual-acting mechanism of action – an approach that differs from traditional therapies and one that can be easily incorporated into a child's daily life.

"This coverage milestone brings us closer to our goal of helping as many amblyopia patients as we can," said Scott Xiao, Luminopia's Co-Founder and CEO. "We're proud to be addressing a significant unmet need in amblyopia care today by further increasing access to our unique and effective software-driven treatment that's backed by strong clinical data and multiple FDA clearances."

Luminopia works differently than traditional amblyopia treatments such as eye-patching and blurring eye drops. Rather than blocking the stronger eye like traditional treatments, Luminopia uses a unique, binocular method that encourages both eyes to work together. Patients watch popular, kid-friendly TV shows inside a VR headset for one hour a day, six days a week, making the treatment more engaging and leading to approximately 94% of parents preferring Luminopia over eye-patching. Clinical trials demonstrated significant vision improvement in as little as four weeks, in both newly diagnosed patients and in children who had already tried traditional therapies.

"It is incredibly encouraging that an innovative treatment option like Luminopia has become more accessible to children," said Dr. Derek Sprunger, Professor at Indiana University School of Medicine, Pediatric Ophthalmology & Strabismus. "We are witnessing a transformative moment in amblyopia care, with more children gaining access to a therapy that not only improves outcomes but is also enjoyable to use. This represents a crucial step toward fewer children being left at risk of permanent vision loss."

This news underscores Luminopia's continued momentum and arrived just a week after the U.S. Food & Drug Administration (FDA) cleared Luminopia's treatment for patients aged 8 to 12 years, expanding its previous label from patients 4 to 7 years old to patients 4 to <13 years old.

Luminopia is being prescribed by physicians at top eye institutes, children's hospitals and private practices across the U.S. today. Eye care professionals can prescribe 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 8-12 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