Real-World Data Reinforces Efficacy of Luminopia in Improving Vision for Patients with Amblyopia

Findings from a real-world patient registry presented at recent scientific meetings, including American Association for Pediatric Ophthalmology and Strabismus, Association for Research in Vision and Ophthalmology, and European and International Strabismological Association

Patients with matched baseline characteristics to the Luminopia Phase 3 clinical trial achieved similar vision improvement and treatment adherence as clinical trial participants

CAMBRIDGE, Mass., June 18, 2024 /PRNewswire/ -- Luminopia Inc., a digital health company pioneering a new class of treatments for neuro-visual disorders, today announced that real-world data (RWD) from the Patients Using Prescription Luminopia (PUPiL) Registry™ continues to demonstrate efficacy of the FDA-approved¹ therapy in improving vision for children with amblyopia. 

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

The data presented at the European and International Strabismological Association conference in Toulouse, France by Derek Sprunger, MD, FAAO, Professor, 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.

This initial 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.

Despite amblyopia being 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 over 50% of patients. Patients using Luminopia watch popular kids TV shows for 1 hour per day, 6 days per week in a VR headset to improve vision instead of wearing an eye patch. 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 together. The immersive VR environment minimizes distractions during treatment and ensures images are presented at optical infinity.

Summarizing the RWD and Luminopia's efficacy, Dr. Sprunger said, "The analysis of real-world data from the PUPiL registry demonstrates the benefit of digital therapy in improving outcomes for amblyopia. Luminopia's unique 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. The objectively-measured compliance is quite encouraging and a significant improvement over traditional treatments like patching."

"For decades, 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. "Our product can improve outcomes for patients thanks to both our unique mechanism and better patient compliance. This registry data further validates that our therapy is effective, easy for young patients to use, and has significant benefit in the real world."

About Luminopia

Luminopia is the first FDA-approved¹ digital therapeutic for a neuro-visual disorder, indicated to improve vision in children with amblyopia. With Luminopia, patients choose TV shows and movies to watch from a selection of 1100+ hours of popular, engaging, and educational content. Dual-acting algorithms modify the selected videos in real time within a virtual reality (VR) headset to promote weaker eye usage and encourage patients' brains to combine input from both eyes. Unlike conventional treatments like eye-patching, blurring (atropine) eye drops, and other digital therapies, which just penalize the stronger eye, Luminopia teaches patients to use both eyes together in a unique, binocular manner.

Luminopia has been validated through a series of clinical trials, including a Phase 3 pivotal trial that demonstrated its safety and efficacy in children aged 4-7 with amblyopia. The Phase 3 pivotal trial was the first successful, randomized, controlled trial of a novel amblyopia treatment in almost 15 years, and the results were published in Ophthalmology, the journal of the American Academy of Ophthalmology. Pilot studies have also shown efficacy in older children and adolescents, where eye-patching and blurring (atropine) eye drops are largely ineffective.

Indications for Use for Luminopia

Luminopia is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs), which are compatible with the software application. Luminopia is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye care professional. Luminopia is intended for both previously treated and untreated patients; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. Luminopia is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia therapy. Luminopia is intended for prescription use only, in an at-home environment.

About Amblyopia

Amblyopia, commonly referred to as lazy eye, is a medical condition characterized by reduced vision that cannot be explained by structural abnormalities alone. Often diagnosed in young children, amblyopia is driven by neurological deficits, which suppress the visual input from the weaker eye, leading to long-term deficits in vision. Amblyopia can be caused by a variety of different factors, including a refractive error such as nearsightedness (myopia), farsightedness (hyperopia), or astigmatism; strabismus, which is when one eye drifts; or rarely, cataracts or cloudiness in the lens. Amblyopia is the most common cause of vision loss in children and affects 3% of children worldwide. In addition, amblyopia is associated with a higher risk of lifetime bilateral vision loss and several mental health conditions including ADHD, anxiety, and depression. Current treatment options of eye-patching and blurring (atropine) eye drops are monocular approaches, which do not train the eyes to work together and are not sufficient in many cases to restore full visual function. Poor patient compliance and social stigmas also present significant challenges with existing treatment options.

About Luminopia, Inc.

Luminopia, Inc. is pioneering a new class of treatments for significant neuro-visual disorders. Luminopia is committed to creating digital therapeutics that are both rigorously evaluated for FDA approval and genuinely engaging for patients. The company is an Innovation Partner of Boston Children's Hospital* and developed its lead product to improve vision in children with amblyopia, the leading cause of vision loss among children. For more information, visit luminopia.com.

LUMINOPIA is a trademark of Luminopia, Inc.

*Boston Children's Hospital holds equity in Luminopia. David Hunter, MD, Ph.D., Ophthalmologist-in-Chief at Boston Children's Hospital is an advisor to Luminopia and holds equity.

1. De Novo granted in Oct 2021, 510(k) clearance in Nov 2022 to expand the list of compatible headsets.

SOURCE Luminopia