The policy further expands access to Luminopia’s engaging, FDA-cleared treatment for children with lazy eye
CAMBRIDGE, Mass., Feb. 25, 2026 /PRNewswire/ — Luminopia, Inc., a digital health company pioneering a new class of treatments for neuro-visual disorders, today announced that CareFirst BlueCross BlueShield, a large health plan servicing patients in Maryland, D.C. and parts of Virginia, has approved its FDA-cleared treatment for amblyopia, commonly referred to as “lazy eye,” for coverage. The policy further expands access to Luminopia, allowing more patients to benefit from this engaging and effective therapy for amblyopia patients aged 4 to 12 years old that enables them to watch popular TV shows as treatment.
This decision marks another important step in Luminopia’s mission to reach as many amblyopia patients as possible, coming just months after Anthem Blue Cross Blue Shield also approved Luminopia for coverage.
“This latest coverage decision from CareFirst builds on the momentum we’re seeing from national and regional health plans. Following Anthem’s recent coverage approval, this policy from CareFirst reflects growing payer confidence in Luminopia and underscores the clinical value proposition of our treatment,” said Scott Xiao, Luminopia’s Co-Founder and CEO. “We applaud CareFirst for helping more children with lazy eye access the treatment they need to improve their vision.”
Amblyopia, or lazy eye, is the leading cause of vision loss in children, affecting approximately one child in every classroom. While eye-patching has long been the standard of care, it is a monocular therapy that is often challenging for patients and their families to adhere to. This leaves many patients with persistent vision loss for life, despite years of treatment. Luminopia works differently than eye-patching because it uses a unique, binocular method that encourages both eyes to work together.
“Luminopia has changed the way we approach amblyopia care,” says Dr. Moran Roni Levin, MD, Associate Professor of Ophthalmology and Pediatrics at University of Maryland School of Medicine. “I have seen patients who have struggled with, or still had vision loss after eye-patching or drops in the past experience meaningful vision improvements with Luminopia. CareFirst’s coverage decision means more children with amblyopia can access an innovative treatment option that fits into their daily lives and keeps them engaged.”
With Luminopia, patients watch popular, kid-friendly TV shows inside a VR headset for one hour a day, six days a week to improve their vision, making treatment engaging and effective. Supported by multiple clinical trials and robust real-world evidence, Luminopia is FDA-cleared for children aged 4 to 12 years.
To learn more about Luminopia, 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 approval¹ 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 broad selection 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.
SOURCE Luminopia