FDA Expands Luminopia’s Label to Include Amblyopia Patients Aged 8 to 12

Luminopia has announced that the U.S. Food and Drug Administration (FDA) has expanded the label of its amblyopia treatment to include patients aged 8 to 12 years, broadening its previous indication, which was limited to patients aged 4 to 7 years with amblyopia associated with anisometropia and/or mild strabismus.

This label expansion provides a new therapeutic option for approximately 400,000 children in the U.S. within the 8–12 age group and represents the first FDA clearance of an amblyopia treatment for this age range in more than 20 years.

A Novel Binocular Therapeutic Approach

Unlike traditional amblyopia treatments—such as eye-patching or atropine eye drops—Luminopia employs a binocular approach that engages both eyes simultaneously. The therapy delivers therapeutic visual stimulation through a virtual reality (VR) headset, allowing patients to watch their favorite TV shows while therapeutic algorithms work to treat the condition.

Treatment consists of 1 hour per day, 6 days per week, offering a more engaging and patient-friendly alternative to conventional methods.

FDA Decision Based on Real-World Evidence from the PUPiL Registry

The FDA’s expanded clearance was granted based on real-world evidence (RWE) gathered from Luminopia’s 'Patients Using Prescription Luminopia' (PUPiL) Registry (NCT06429280). According to Luminopia, the PUPiL Registry is the largest amblyopia treatment registry to date, enrolling more than 500 patients across 45 prescribers at 14 academic and community centers.

The registry’s all-comers design allows for comprehensive evaluation of outcomes in a real-world, representative patient population.

Substantial Equivalence in Safety and Efficacy

The FDA determined that Luminopia’s safety and efficacy in patients aged 8 to 12 are substantially equivalent to those observed in the 4–7 age group. Furthermore, data from the PUPiL Registry showed that patients previously treated with traditional therapies for an average of 1.8 years before switching to Luminopia still gained an additional line of vision, demonstrating Luminopia’s potential benefit even after conventional treatments plateau.

Industry Milestone in Regulatory Approval via RWE

“This is the first instance in ophthalmology where the FDA has provided clearance based solely on real-world evidence,” said Scott Xiao, Co-Founder and CEO of Luminopia.

“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. 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.”