Luminopia Shows Promise in Improving Control of Intermittent Exotropia in Pilot Study

FDA-cleared digital therapeutic demonstrates early evidence of improved eye movement control in children with intermittent exotropia 

CAMBRIDGE, Mass., March 25, 2026 /PRNewswire/ -- Luminopia, Inc., a digital health company pioneering a new class of treatments for neuro-visual disorders, today announced preliminary findings from a pilot study, led by Dr. Evan Silverstein, Associate Professor at Virginia Commonwealth University Medical School, evaluating its prescription digital therapeutic in children with intermittent exotropia (IXT), a condition in which one eye occasionally drifts outward. The study suggests that the binocular treatment may improve eye movement control in this difficult-to-treat condition. 

The study analyzed 10 children aged 4-7 with unilateral IXT, who were prescribed one hour per day of Luminopia therapy, six days per week and achieved ≥50% adherence. Control scores and stereopsis were measured at baseline, after three months of treatment, and after a three-month washout period (i.e., six months after baseline).

Key findings include: 

• 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 towards improvement in 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," said Dr. Silverstein, study author. "This lays the groundwork for Luminopia to potentially become the first non-surgical, FDA-cleared treatment for IXT." 

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

To learn more about Luminopia, visit www.luminopia.com.

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 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 children with amblyopia, the leading cause of vision loss among children. For more information, visit luminopia.com.

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 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, which just 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 <13 years and validated through a series of 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 robust 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, leading to a subsequent label expansion clearance.

For more information, visit luminopia.com.

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

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 to <13, 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. 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.

SOURCE Luminopia