Luminopia Announces First International Licensing Agreement with ROHTO Pharmaceutical to Launch Pediatric Amblyopia Treatment in Japan

Partnership expands global access to Luminopia's FDA-cleared lead product

CAMBRIDGE, Mass., June 2, 2026 /PRNewswire/ -- Luminopia, Inc., a digital health company pioneering a new class of treatments for neuro-visual disorders, announced its first international licensing agreement with ROHTO Pharmaceutical Co., LTD, a Japanese multinational corporation specializing in consumer products and pharmaceuticals, with a primary focus on eye care.

Amblyopia, or lazy eye, is the leading cause of vision loss in children globally and affects approximately two percent of children in Japan. Luminopia offers a modern, FDA-cleared therapy that allows pediatric patients to watch television through a virtual reality (VR) headset for one hour a day, six days a week, as treatment.

Luminopia reimagines the outdated approach to amblyopia treatment. For decades, patients have relied on eye-patching, which requires covering the stronger eye for multiple hours per day. Patching can make school, everyday activities and social interactions more challenging, leading to poor compliance and a significant unmet need. Luminopia provides an alternative to the patch that encourages the eyes to work together, rather than just penalizing the stronger eye. Treatment is delivered through the modification of popular kids media content, including shows licensed from Pokemon and Crunchyroll. .

The agreement grants ROHTO exclusive rights to develop and commercialize Luminopia's digital therapy for pediatric amblyopia in the Japanese market. Under the terms of the agreement, ROHTO will lead clinical development and commercialization efforts in Japan. The partnership demonstrates the scalability of Luminopia's therapeutic platform and commercial model, and serves as a blueprint for bringing its FDA-cleared therapy to patients globally.

"This partnership with ROHTO serves as validation of both our technology and its potential impact within the Japanese market," said Scott Xiao, founder and CEO of Luminopia. "ROHTO's strong relationships with Japanese ophthalmologists, combined with their well-established brand and extensive experience working with the Pharmaceuticals and Medical Devices Agency, make them the ideal partner to bring this therapy to children and families in need."

Despite Japan's robust pediatric vision screening programs, amblyopia treatment has seen little innovation over the past decades. Luminopia offers a fundamentally new approach: children watch popular TV shows and movies through a VR headset as therapy, making treatment more enjoyable and helping improve adherence and outcomes.

"We are pleased to partner with Luminopia. Building on ROHTO's experience in eye care, we look forward to advancing a new option for children with amblyopia and their families in Japan.," said ROHTO Pharmaceutical Co., LTD.

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.

About ROHTO Pharmaceutical Co., LTD
ROHTO Pharmaceutical is a Japan-based healthcare company that operates across a wide range of fields, including pharmaceuticals, cosmetics, and functional foods, and contributes to people's beauty, health, and well-being, with eye care as one of its core areas.

SOURCE Luminopia