The U.S. Food and Drug Administration (FDA) has cleared Luminopia's digital therapeutic for amblyopia in patients aged 8 to 12 years, marking the first new treatment approval for this age group in more than two decades. This expansion of the existing label now allows treatment for children aged 4 to under 13 years with amblyopia associated with anisometropia and/or mild strabismus.
The expanded approval opens treatment options for approximately 400,000 children aged 8-12 in the United States suffering from amblyopia, commonly known as "lazy eye," which is the leading cause of vision loss in children, affecting roughly one child in every classroom.
FDA Approval Based on Real-World Evidence
In a notable regulatory development, the FDA's decision was based entirely on real-world evidence (RWE) collected through Luminopia's Patients Using Prescription Luminopia (PUPiL) Registry™ (NCT06429280). According to Scott Xiao, Luminopia's Co-Founder and CEO, "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 PUPiL Registry represents the largest amblyopia treatment registry to date, comprising more than 500 patients from 45 prescribers across 14 academic and community centers, including Boston Children's Hospital, Children's Hospital of Philadelphia, and The Johns Hopkins Wilmer Eye Institute. The FDA determined that Luminopia's safety and efficacy in the 8-12 age group is substantially equivalent to its performance in younger patients aged 4-7 years.
Significantly, patients in the registry who had previously been treated with traditional therapies for an average of 1.8 years before switching to Luminopia were still able to gain an additional line of vision, demonstrating efficacy even in previously treated cases.
Novel Binocular Treatment Approach
Luminopia's approach differs fundamentally from traditional amblyopia treatments such as eye-patching and atropine eye drops. Rather than simply penalizing the stronger eye, Luminopia employs a binocular approach that engages both eyes simultaneously.
The treatment allows patients to watch their favorite TV shows through a virtual reality (VR) headset for one hour daily, six days per week. Proprietary algorithms modify the selected videos in real-time to promote weaker eye usage and encourage the brain to combine input from both eyes. Patients can choose from over 1,100 hours of popular, engaging content, including shows like Sesame Street and SpongeBob SquarePants.
"Luminopia is the only treatment for amblyopia that has demonstrated comparable efficacy in young children and pre-teens," noted Dr. Robert Gold, 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."
Addressing a Critical Treatment Gap
The expanded approval addresses a significant unmet need, as the efficacy of traditional approaches like eye-patching is known to decline significantly after age 8. Clinical studies have shown that Luminopia can lead to significantly improved vision at 12 weeks—even in patients previously treated with traditional therapies.
Luminopia's digital therapeutic was initially granted De Novo approval in October 2021 for children aged 4-7 years, following the first successful randomized controlled trial of a novel amblyopia treatment in almost 15 years. The results of that pivotal Phase 3 trial were published in the journal Ophthalmology.
Prescription and Availability
Luminopia is a prescription-only digital therapeutic intended for at-home use. It is designed to be used with commercially available head-mounted displays (HMDs) compatible with the software application. The treatment is intended as an adjunct to full-time refractive correction, such as glasses, which should be worn under the HMD during therapy.
The digital therapeutic can be prescribed by eye care professionals through CoAssist Pharmacy, making this innovative treatment accessible to the expanded patient population immediately.
Luminopia, Inc., based in Cambridge, Massachusetts, is pioneering a new class of treatments for neuro-visual disorders and is an Innovation Partner of Boston Children's Hospital. The company focuses on creating digital therapeutics that are both rigorously evaluated for FDA approval and genuinely engaging for patients.
