Anthem Blue Cross, Blue Shield approves coverage for amblyopia treatment from Luminopia

Luminopia's amblyopia therapy requires watching shows for 1 hour a day, 6 days a week. In clinical trials, patients showed signs of improvement in as little as 4 weeks.

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Today, Luminopia announced that its amblyopia treatment has been approved by Anthem Blue Cross and Blue Shield for insurance coverage.¹ The news comes on the heels of the FDA’s age extension of clearance for Luminopia’s amblyopia treatment, now indicating treatment from patients aged 4 to 7 to patients aged 4 to 12 years.² Both are steps toward expanding access to the unique, entertainment-based amblyopia treatment nationwide.

Luminopia’s FDA-approved amblyopia therapy encourages both eyes to work together while watching kid-friendly TV shows or movies via a virtual reality (VR) headshot. The therapy requires watching shows for 1 hour a day, 6 days a week. In clinical trials, patients showed signs of improvement in as little as 4 weeks. As the second largest health plan in the US, Anthem’s coverage of Luminopia will significantly extend access to digital amblyopia treatment. Anthem’s criteria for coverage were not disclosed in the news release.

“This coverage milestone brings us closer to our goal of helping as many amblyopia patients as we can,” Scott Xiao, Luminopia's cofounder and CEO, said in a press release. “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.”

Amblyopia, traditionally treated by eye-patching or use of blurring drops, is a neural disorder caused by abnormal brain stimulation during brain development. Luminopia’s digital therapeutic includes a selection of popular content, often educational, that is modified by dual-acting algorithms in real time to promote usage of the weaker eye and to strengthen binocular usage. Patients can choose from a library of over 1100 hours of movies and television shows and complete amblyopia treatment by watching TV through a VR headset.

“It is incredibly encouraging that an innovative treatment option like Luminopia has become more accessible to children," Derek Sprunger, MD, professor at Indiana University School of Medicine, Pediatric Ophthalmology & Strabismus, said in a press release. "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."

The software was cleared by the FDA following a pivotal phase 3 trial, which was the first successful randomized, controlled trial of a novel treatment for amblyopia in nearly 15 years. The results were published in Ophthalmology in September 2021,³ which paved the way for the initial de novo approval from the FDA in October 2021 for patients aged 4 to 7 years. The more recent age expansion was based on Luminopia’s robust database of real-world evidence as generated through its Patient Using Prescription Luminopia (PUPiL) registry. The FDA used the data to determine that the safety and efficacy in patients 8 to 12 is equivalent to safety and efficacy in patients aged 4 to 7, and the therapeutic is now approved for use in patients 4 to <13.

Luminopia’s VR-based amblyopia therapeutic was approved by the FDA in October 2021. The company received 510(k) clearance in April 2025 to extend the age range for treatment. Eye care providers who wish to prescribe Luminopia can do so through CoAssist Pharmacy.

References

1. Luminopia Announces That Anthem Blue Cross and Blue Shield Has Approved Its Amblyopia Treatment for Coverage. Press release. Published May 8, 2025. Accessed May 8, 2025.

2. Joy J. FDA clears expansion of Luminopia amblyopia treatment to include 8 to 12 year old patients. Optometry Times. Published April 30, 2025. Accessed May 8, 2025. https://www.optometrytimes.com/view/fda-clears-expansion-of-luminopia-amblyopia-treatment-to-include-8-to-12-year-old-patients

3. Xiao S, Angjeli E, Wu HC, et al. Randomized Controlled Trial of a Dichoptic Digital Therapeutic for Amblyopia [published correction appears in Ophthalmology. 2022 May;129(5):593. doi: 10.1016/j.ophtha.2022.02.012.]. Ophthalmology. 2022;129(1):77-85. doi:10.1016/j.ophtha.2021.09.001