Luminopia Inc. announced that the US Food and Drug Administration (FDA) cleared its amblyopia treatment for patients aged 8 to 12 years, expanding its existing label from patients 4 to 7 years old to patients 4 to <13 years old with amblyopia associated with anisometropia and/or mild strabismus. This marks the first FDA clearance for an amblyopia treatment for this age range in more than 2 decades, the company said in a press release.
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 the company, the PUPiL Registry 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 including Boston Children's Hospital, Children's Hospital of Philadelphia, Lurie Children's Hospital of Chicago, UCSF Benioff Children's Hospitals, and The Johns Hopkins Wilmer Eye Institute. The PUPiL Registry, combined with data from Luminopia's phase 1, 2 and 3 clinical trials, make Luminopia the most thoroughly studied digital treatment for amblyopia, the company said in the press release.
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, the company said.
Luminopia takes 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. With access to 75 carefully curated, kid-friendly shows such as Sesame Street and SpongeBob SquarePants, Luminopia encourages patient engagement and can lead to significantly improved vision at 12 weeks as demonstrated in clinical studies—even in patients who have been previously treated with traditional therapies, the company said.
According to the company. Luminopia can be prescribed by eye care professionals through CoAssist Pharmacy. For more information, visit www.luminopia.com.