FDA Expands Luminopia's Label to Include Patients 8 to 12 with Amblyopia

Luminopia announced that the FDA has cleared its amblyopia treatment for patients aged 8 to 12 years, expanding its existing label from patients 4 to 7 years old with amblyopia associated with anisometropia and/or mild strabismus. The expanded label opens the door to a new treatment option for about 400,000 8- to 12-year-olds in the U.S. suffering from amblyopia, and marks the first FDA clearance for an amblyopia treatment for this age range in more than two decades.

Luminopia works differently than traditional therapies, such as eye-patching and atropine eye drops, by taking a binocular approach to treating amblyopia. Luminopia allows patients to watch their favorite TV shows through an immersive VR headset for 1 hour a day, 6 days a week, and overlays therapeutic algorithms that engage both eyes to treat the condition. 

The FDA's decision was based on Luminopia's database of real-world evidence (RWE), generated through its 'Patients Using Prescription Luminopia (PUPiL) Registry' (NCT06429280). According to Luminopia, the PUPiL Registry is the largest amblyopia treatment registry to-date and uses an all-comers' design to evaluate real-world outcomes in a representative population. It's comprised of more than 500 patients and counting, from 45 prescribers at 14 academic and community centers. 

The FDA determined that Luminopia's safety and efficacy in patients aged 8 to 12 years is substantially equivalent to its safety and efficacy in patients aged 4 to 7 years. Additionally, patients in Luminopia's PUPiL Registry were treated with traditional therapies for an average of 1.8 years prior to switching to Luminopia and they were still able to gain an additional line of vision, according to Luminopia. 

"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 FDA's decision is a testament to the rigorous design of the PUPiL Registry and the strength of our product's safety and efficacy," Scott Xiao, Luminopia's Co-Founder and CEO, said in a company news 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."

Luminopia can be prescribed by eye care professionals through CoAssist Pharmacy. For more information, visit www.luminopia.com.