Data demonstrates efficacy of FDA-approved therapy for treating amblyopia in children

(Image Credit: AdobeStock/ArtSys)

Luminopia is highlighting real-world data from the Patients Using Prescription Luminopia (PUPiL) Registry that continues to demonstrate efficacy of the FDA-approved therapy in improving vision for children with amblyopia.

According to the company, its approach to treating amblyopia in young children couples proprietary therapeutic software with virtual reality (VR) headsets and popular children's TV shows. IT has been available on the market for over a year following rigorous clinical trials and de novo FDA premarket approval.

"For years, the standard-of-care treatment for amblyopia has been to patch the stronger eye, but the majority of patients who go through patching are still left with the condition," said Scott Xiao, Luminopia's co-founder and CEO. "Luminopia can improve outcomes for patients thanks to our mechanism as well as better patient compliance.”

According to the company, the data presented at the European and International Strabismological Association conference in Toulouse, France by Derek Sprunger, MD, FAAO, a professor at the Indiana University School of Medicine, further support the topline data presented at recent international scientific meetings.

Results from the PUPiL Registry were first presented at the American Association for Pediatric Ophthalmology and Strabismus (AAPOS) 2024 annual meeting in April by Euna Koo, MD, Clinical Associate Professor of Ophthalmology, Stanford University and then at the Association for Research in Vision and Ophthalmology (ARVO) 2024 annual meeting in May, by Fatema Ghasia, MD, at the Cole Eye Institute, Cleveland Clinic.

The first registry analysis of 179 patients from 10 clinical sites showed significant improvement in visual acuity after 12 weeks of Luminopia treatment in a broad population. The cohort of patients with similar baseline characteristics to Luminopia clinical trial participants improved by 1.7 lines in 12 weeks and had 83% median treatment adherence, in line with the pivotal trial results.

Across the registry, subgroups of patients with respect to amblyopia severity, prior treatment experience, age, and type of amblyopia all showed significant vision improvement after 12 weeks of treatment and no safety events were reported. These outcomes confirm the efficacy of Luminopia in the real world and, importantly, demonstrate its clinical benefit as both a first and second-line treatment.

“This registry data further validates that our therapy is effective, easy for young patients to use, and has significant benefit in the real world,” Xiao said.

Xiao noted that even though amblyopia has been identified as the leading cause of vision loss in children, the traditional therapies of patching and atropine eye drops only block vision in the stronger eye and are associated with poor treatment compliance and residual vision deficits in more than 50% of patients.

Luminopia is software based, and Xiao explained patients use it to watch popular children television shows for 1 hour per day, 6 days per week in a VR headset to improve vision instead of wearing an eye patch.

Xiao noted that the company has partnered with companies like Nickelodeon, Sesame Street, and PBS Kids to create alibrary of more than 3000 hours of content for patients to choose from and watch during treatment.

“Our proprietary software algorithms modify that content in real time via a dual-acting mechanism which encourages the brain to prioritize the weaker eye and use both eyes simultaneously,” Xiao added.

Xiao explained that dichoptic masks take away parts of the image in both eyes

“When the patient is looking at the video, they're having to fit the puzzle pieces together in order to appreciate the full video,” he said. “That's what makes it a binocular approach a binocular mechanism, and really differentiates it from any of the treatments that have come beforehand.”

Xiao further noted that the VR environment also reduces potential distractions during treatment, which helps to ensure that images are presented at optical infinity.

Sprunger added that the analysis of real-world data from the PUPiL registry demonstrates the benefit of digital therapy in improving outcomes for amblyopia.

“Luminopia's mechanism of action, which doesn't just penalize the strong eye but uses dichoptic masking to encourage binocular fusion, is proving to be effective for a broad range of patients,” he concluded. “The objectively-measured compliance is quite encouraging and a significant improvement over traditional treatments like patching."