Justin Cooper , 2025-04-23 17:20:00
April 23, 2025
2 min read
Key takeaways:
- Luminopia is now available to treat amblyopia in children aged 4 to 12 years old.
- Patients watch TV shows through a virtual reality headset, promoting use of the weaker eye.
Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA cleared Luminopia, a virtual reality-based therapeutic for amblyopia, for use in children aged 8 to 12 years old, adding to its existing approval in children aged 4 to 7 years old, according to a press release.
The FDA cleared Luminopia, a virtual reality-based therapeutic for amblyopia, for use in children aged 8 to 12 years old, adding to its existing approval in children aged 4 to 7 years old. Image: Adobe Stock
It represents the first FDA clearance in more than 20 years for amblyopia in this age range, which has traditionally been treated with eye patching and atropine drops, according to Luminopia.
“Luminopia is the only treatment for amblyopia that has demonstrated comparable efficacy in young children and preteens,” Robert S. Gold, MD, FAAP, a pediatric ophthalmologist at Eye Physicians of Central Florida and past president of the American Association for Pediatric Ophthalmology and Strabismus, said in the release. “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.”
The device works by having patients watch TV shows through a VR headset, with therapeutic algorithms overlaid to engage both eyes, according to Luminopia. The videos are modified in real time to encourage use of the weaker eye, with the brain combining input from both eyes. Patients use the device for 1 hour a day, 6 days a week.
In clinical studies, vision was significantly improved as early as 12 weeks, including among patients previously treated with other therapies.
This additional clearance was supported by real-world evidence in the Patients Using Prescription Luminopia registry, which consists of more than 500 patients. The FDA determined the device’s safety and efficacy in the new age range was substantially equivalent to that of the previous approval.
“It’s rare for the FDA to provide clearance based on [real-world evidence] alone, and as far as we’re aware, this is the first instance of it being done in [eye care],” Scott Xiao, co-founder and CEO of Luminopia, said in the release. “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.”
