Study Indicates Potential of ‘Binocular’ Treatment for Intermittent Exotropia

Luminopia Inc. is sharing encouraging preliminary study data suggesting its prescription digital therapeutic can help improve eye movement control in children with intermittent exotropia (IXT), a condition in which one eye occasionally drifts outward.

Led by Dr. Evan Silverstein, associate professor at Virginia Commonwealth University Medical School, the study analyzed 10 children ages 4 to 7 with unilateral IXT who were prescribed one hour per day of Luminopia therapy, six days per week, and achieved ≥50% adherence. Study organizers measured control scores and stereopsis at baseline after three months of treatment, and after a three-month washout period (i.e., six months after baseline).

“This pilot study offers promising early data and underscores the potential of dichoptic therapy to transform care for children with intermittent exotropia,” Luminopia Founder/CEO Scott Xiao stated. “The findings also validate the broader therapeutic potential of our platform in treating conditions at the intersection of the visual system and the brain.”

Key findings:

• Distance control scores improved significantly from a mean of 2.9 at baseline to 1.7 after three months (p=0.01).
• Improvement at three months did not regress at six months, suggesting a potential sustained benefit.
• There was a trend toward stereoacuity as well.

“While this is a small pilot, these findings are exciting because they suggest that dichoptic therapy delivered via Luminopia may improve control in children with IXT,” Dr. Silverstein, study author, said. “This lays the groundwork for Luminopia to potentially become the first non-surgical FDA-cleared treatment for IXT.”

Luminopia Inc. is pioneering new treatments for significant neuro-visual disorders. The company creates digital therapeutics that are evaluated for U.S. Food and Drug Administration (FDA) approval¹ 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 pediatric amblyopia, the leading cause of vision loss among children.

Luminopia is the first FDA-approved¹ digital therapeutic for a neuro-visual disorder, indicated to improve vision in pediatric amblyopia. With Luminopia, patients choose TV shows and movies to watch from a broad selection 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 that penalize the stronger eye, Luminopia teaches patients to use both eyes together in a unique, binocular manner.

Luminopia has been cleared by the FDA for children aged 4 to 12 years and validated through clinical trials as well as a real-world registry. 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, leading to the initial FDA approval for patients aged 4 to 7 years. Based on the real-world evidence collected through the PUPiL Registry, the FDA determined that Luminopia’s safety and efficacy in patients aged 8-12 years is substantially equivalent to its safety and efficacy in patients aged 4 to 7 years, which led to a subsequent label expansion clearance.

Reference
¹ De Novo granted in Oct 2021, 510(k) clearance in Apr 2025 to expand the age range.