Luminopia Files for IPO Following FDA-Approved VR Therapy for Pediatric Amblyopia and $16M Series A Round

"How to Train Your Dragon," "Sesame Street," "Wild Kratts"… The main characters of these animations unexpectedly appear on the homepage of a prescription digital therapeutics company. A dazzling array of movies and TV shows, with over 700 hours of popular films available for selection—this is the standout feature of Luminopia One, a novel digital therapy developed by Luminopia, Inc. to treat amblyopia in children. The therapy allows pediatric patients with amblyopia to improve their vision simply by "watching TV."

Luminopia is a medical company dedicated to developing innovative treatments for neurovisual disorders. Established in 2015, its headquarters is located in Cambridge, Massachusetts, USA. Its CEO, Scott Xiao, and co-founders met at Harvard. After learning from a childhood friend with amblyopia about the condition, they were astonished to discover that no breakthrough innovations in amblyopia treatment had emerged in nearly two decades. The treatment methods of wearing eye patches and using eye drops have remained unchanged.

These two treatment methods commonly face challenges of poor compliance and suboptimal effectiveness. Consequently, Scott Xiao and his co-founder developed an early prototype of Luminopia One and presented it to ophthalmologists at Boston Children's Hospital. Encouraged by the positive feedback from the doctors, they founded the company Luminopia, Inc. to make this product accessible to more patients, providing children with amblyopia a simple, engaging, and effective treatment option.

In the past few years, Luminopia One has been studied at some of the top academic institutions in the United States, including the Cleveland Clinic, UCLA Jules Stein Eye Institute, Duke Eye Center, and Children's Hospital of Philadelphia, among others.

Amblyopia is a neurovisual disease caused by defects in the brain rather than problems with the eyes. It results in reduced vision in one eye while the other eye has normal or near-normal vision. Amblyopia is typically caused by anisometropia or strabismus during childhood and commonly occurs in early childhood (typically ages 4-7). If left untreated, it may lead to permanent vision loss and increase the lifelong risk of blindness, becoming a leading cause of vision loss in children. The article "Risk of bilateral visual impairment in individuals with amblyopia: the Rotterdam study" points out that individuals with amblyopia are 2.6 times more likely to experience bilateral vision loss compared to normal individuals. Another article, "A nationwide cohort study on the risk of ADHD in children with amblyopia mediated by fine motor skill impairment in East Asia," indicates that children with amblyopia are 1.7 times more likely to have attention deficit hyperactivity disorder (ADHD) compared to normal individuals.

Although traditional therapies have been around for decades, they still do not fully meet the needs of pediatric patients. Most patients correct refractive errors by wearing corrective lenses, but this does not address the fundamental issue of how the brain receives images. The use of eye patches and atropine eye drops has always shown poor compliance, and wearing an eye patch often leads to feelings of inferiority in children. A study conducted by a hospital in Saudi Arabia surveyed 37 families with children who used eye patches to treat amblyopia. The children in the study wore their patches for only about 66% of the prescribed time. Some families cited social stigma, discomfort, and refusal to wear the patch as common reasons for non-adherence. A 2013 study in *Investigative Ophthalmology & Visual Science* analyzed compliance with eye patch treatment among 152 children and found that the patches were not worn approximately 42% of the time.

Even if patients are willing to cooperate, many still fail to recover after treatment. This is because traditional therapies essentially address symptoms rather than root causes—they force the amblyopic eye to work without training the eyes to cooperate correctly with each other. The article "A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children" points out that a nationwide study in China showed that 75% of patients still experienced significant vision loss after undergoing eye-patching treatment.

Therefore, children with amblyopia urgently need a more engaging and effective new treatment option. More importantly, this new treatment should teach them how to use both eyes correctly at the same time.

Luminopia One, developed by Luminopia, solves this problem. Luminopia One is a VR-based digital therapy that effectively improves the vision of children with amblyopia. During treatment, all children need to do is select a video, put on a VR headset, and sit back to watch. They can choose from over 700 hours of popular TV shows and movies, which is why compliance in clinical trials for Luminopia One was twice as high as that of patch therapy. Additionally, Luminopia recommends usage of one hour per day, six days a week, aligning with the American Academy of Pediatrics' screen time guidelines for young children.

The principle of Luminopia One is to stimulate and train the visual function of the weaker eye by having patients watch specially processed TV shows or movies through a VR headset. The software algorithm of Luminopia One modifies the images received by each eye in real time and presents them differently to each eye based on the patient's vision condition.

Unlike eye patches or eye drops, Luminopia One improves vision in patients with amblyopia through two distinct approaches, achieving dual therapeutic effects. On one hand, while applying binocular masking, it reduces the contrast, sharpness, and saturation of images seen by the stronger eye, enhancing the clarity, contrast, and saturation of images received by the weaker eye. On the other hand, binocular masking removes parts of the image from each eye, teaching the brain to combine inputs from both eyes. The goal is to rebalance the brain’s processing of visual input from both eyes, forcing the brain to use both eyes together to form a complete image and training the eyes to work cooperatively. The treatment uses child-friendly VR headsets to display images, allowing therapy to take place in an undisturbed, controlled environment. Images inside the headset are also optically projected at infinity, eliminating concerns about close-range eye strain.

So, how to access Luminopia One service?

First, the doctor will send the electronic prescription to Luminopia's retail pharmacy partner, PhilRx, without considering inventory, payment, or anything else. PhilRx will send a text message to the patient to help them complete registration, guide them in checking insurance coverage, and then charge the fee. They will ship the VR headset to the patient and send an access code to begin treatment. Once treatment begins, PhilRx will share the patient’s access code with the doctor, who can then use the Luminopia Adherence Portal to track the patient's amblyopia treatment progress, virtually monitoring weekly and overall adherence trends.

Luminopia's current clinical partners include Boston Children's Hospital, Ohio State University, Duke Health, UCLA Stein Eye Institute, and more. In addition, Luminopia collaborates with several renowned experts in pediatric ophthalmology and neuroscience, including Dr. David Hunter, Chief of Ophthalmology at Boston Children's Hospital and Richard Robb Chair in Ophthalmology, Dr. Gil Binenbaum, Chief of Ophthalmology at Children’s Hospital of Philadelphia, and Professor Mark Bear from MIT’s Picower Institute for Neuroscience. To create a more engaging treatment experience for children, Luminopia has also partnered with popular entertainment companies such as Sesame Street, Nickelodeon, and PBS Kids to provide high-quality and diverse TV programming.

In October 2021, Luminopia One received U.S. Food and Drug Administration (FDA) approval via the De Novo pathway, becoming the first FDA-approved treatment for binocular amblyopia in children aged 4-7 and the first FDA-approved digital therapy for treating neurovisual disorders. Currently, Luminopia One is already on the market.

Luminopia One is rooted in cutting-edge neuroscience, building on decades of pioneering research by leading clinicians and neuroscientists at Boston Children's Hospital and MIT. The Luminopia One technology has been tested in three clinical trials across more than 20 hospitals and research institutions in the United States, involving over 200 pediatric patients. Among these was a gold-standard, randomized controlled Phase 3 trial that demonstrated the safety and efficacy of the Luminopia One therapy for children aged 4-7.

Clinical research data shows that patients using Luminopia One therapy demonstrated good compliance, with 85% of patients adhering to the treatment regimen of 6 days per week and 1 hour per day over a 12-week period. Additionally, 86% of pediatric patients experienced improved vision after treatment, and 94% of pediatric patients preferred Luminopia One. In contrast, compliance with eye patching often hovers below 50%. No serious adverse events were reported in the pivotal trial of Luminopia One. After 12 weeks, patients treated with Luminopia One showed an average improvement of 1.8 lines on the standard eye chart, compared to only 0.8 lines in the control group that received corrective lenses alone. This Phase 3 pivotal trial marked the first successful randomized controlled trial for a novel amblyopia treatment in nearly 15 years, with the results published in the journal *Ophthalmology*.

On June 27, 2023, Luminopia completed its Series A financing round of $16 million. This round was led by US Venture Partners, an early-stage venture capital firm focused on information technology and healthcare, with participation from The Vertical Group, Shangbay Capital, and Broadfin Advisors. The funds will support Luminopia in the full commercial promotion of Luminopia One and advance its mission to "pioneer a new treatment method for 15 million Americans suffering from neurovisual disorders."

Digital therapies for ophthalmic system diseases in China first entered hospitals in 2010 in the form of medical software. Digital therapy is a software-driven intervention based on evidence-based medicine, used to treat, manage, or prevent diseases. Compared with traditional training methods, digital therapy technology has the advantages of being highly engaging, offering diverse training modes, and requiring shorter treatment durations. According to the survey results in the "2022 White Paper on the Current Status of Digital Therapy for Strabismus and Amblyopia in Chinese Children," in amblyopia treatment, 34% of doctors chose visual function training therapy software (digital therapy products).

Guangzhou Shijing Medical Software Co., Ltd. is one of the vision health enterprises dedicated to treating amblyopia in children using digital technology. It owns innovative solutions such as "DuoBaoshi" for the treatment of strabismus and amblyopia in children and adolescents, and "BeiBeiLe" for myopia prevention and control. These include a visual training telemedicine platform, VR wearable smart devices, eye-tracking technology, an AI vision screening system, and an AI intelligent solution formulation system, among other self-developed products. Currently, the company has expanded its services across more than 30 provinces (autonomous regions and municipalities) in China and has established stable cooperative relationships with over 2,000 hospitals.

Jiangsu Juehua Medical Technology Co., Ltd. is a brain technology medical company focused on the field of visual health, dedicated to research in visual function detection, visual damage repair, and related technologies, as well as the development, production, and sales of medical devices. Its product, "OrthoVision Amblyopia Visual Function Software," is based on iAVT (Individualized Adaptive Visual Perception Training) technology, creating a new "hospital-to-home" visual health "digital medicine" treatment closed-loop model. The software utilizes the plasticity of the neural system in the brain, customizing personalized visual stimuli and task combinations according to Bayesian precision visual function evaluation and damage models. Based on perceptual learning principles, it conducts adaptive training, incorporates a training effect early warning algorithm, enhances corresponding neuron functions, strengthens existing synaptic connections, promotes the formation of new synapses, and thereby repairs damaged visual pathways, effectively curing amblyopia.

The White Paper on the Current Status of Digital Treatment for Strabismus and Amblyopia in Chinese Children (2022) pointed out that there is still a lack of large-scale epidemiological survey data nationwide for strabismus and amblyopia. Based on the results of population-based epidemiological studies published in the past five years, it is estimated that the overall prevalence of amblyopia in China is 0.82% to 9.60%. The 2023-2029 Global and China Amblyopia Treatment Instrument Industry Research and 14th Five-Year Plan Analysis Report pointed out that the global market size of amblyopia treatment instruments was approximately 430 million yuan (RMB) in 2022, and it is expected to reach 540 million yuan by 2029, with a compound annual growth rate (CAGR) of 3.4% during the period from 2023 to 2029.