How to Train Your Dragon, Sesame Street, Animal Brothers …… The main characters of these animated films are actually featured on the front page of the official website of a prescription digital therapeutics company. A wide array of movies and TV shows, with more than 700 hours of popular favorites to choose from, is what Luminopia One, a new digital therapeutics developed by Luminopia to treat amblyopia in children, is all about – allowing children with amblyopia to improve their vision by “watching TV! This is the most important feature of Luminopia One, a new digital therapeutics developed by Luminopia to treat amblyopia in children – allowing children with amblyopia to “watch TV” to improve their vision.
Luminopia, a medical company focused on pioneering novel treatments for neurovisual disorders, was founded in 2015 and is headquartered in Cambridge, Massachusetts. Its CEO, Scott Xiao, and its co-founders met at Harvard, and after learning about it from a friend who suffered from amblyopia as a child, were both shocked that there hadn’t been a groundbreaking innovation in amblyopia treatments in nearly two decades. Eye shields and eye drops have remained the same.
These two treatments were generally characterized by poor compliance and poor results. So Scott Xiao and his co-founders developed an early prototype of the Luminopia One and presented it to ophthalmologists at Boston Children’s Hospital. With positive feedback and motivation from the doctors, they started their company, Luminopia, in order to make this product reach more patients and provide a simple, fun, and effective treatment option for children with amblyopia.
Over the past few years, Luminopia One has been studied at some of the top academic institutions in the U.S., including the Cleveland Clinic, the Jules Stein Eye Institute at UCLA, the Duke Eye Center, and the Children’s Hospital of Philadelphia.
Amblyopia is a neurovisual disorder caused by a brain defect rather than an eye problem. It causes the patient to have below-normal vision in one eye and normal or near-normal vision in the other. Amblyopia is usually caused by refractive error or strabismus in childhood and occurs most often in young children (usually 4-7 years old). If left untreated, it can lead to permanent vision loss and an increased risk of lifelong blindness, and has become the leading cause of vision loss in children. The article “Risk of bilateral visual impairment in individuals with amblyopia: the Rotterdam study” states that amblyopes are 2.6 times more likely to have binocular vision loss, and “A nationwide cohort study on the risk of ADHD in children with amblyopia” states that “the risk of ADHD in children with amblyopia is 2.6 times greater than that of normal individuals”. the risk of ADHD in children with amblyopia mediated by fine motor skill impairment in East Asia”, and “A nationwide cohort study on ADHD in children with amblyopia mediated by fine motor skill impairment in East Asia”, which states that amblyopes are 1.7 times more likely than normal to have attention deficit hyperactivity disorder.
While traditional therapies have been around for decades, they still don’t adequately address the needs of pediatric patients. Most patients correct refractive errors by wearing corrective lenses, however this does not address the brain’s fundamental problem with image reception. Compliance with eye wear and atropine drops has always been poor, and wearing eye wear can often make children feel inferior. A study conducted at a hospital in Saudi Arabia looked at 37 families with children who used eye masks to treat amblyopia. The children in the study wore the eye patch for only about 66% of the prescribed hours. Some families cited social stigma, discomfort, and refusal to wear the eye patch as common reasons for their difficulty with adherence.A 2013 study in Investigative Ophthalmology and Vision Science analyzed compliance with eye patch therapy among 152 children and found that about 42 percent of the time the children did not wear the patch.
Even when patients are willing to cooperate, many still fail to heal after treatment. That’s because conventional treatments essentially treat the symptoms rather than the cause-they force the amblyopic eye to work, rather than training the eyes to work properly with each other. A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children” states that a national study showed that 75% of patients who were treated with eye wear still had a significant loss of vision. A national study showed that 75% of patients continued to experience significant vision loss after treatment with an eye patch.
As a result, there is an urgent need for a new, more attractive and effective treatment option for children with amblyopia. More importantly, this new treatment should teach them how to properly use both eyes simultaneously.
Luminopia solves this problem with Luminopia One, a VR-based digital therapeutics that improves the vision of amblyopic children. During the therapy, all children have to do is select a video and sit down with a VR headset on to watch it. They can choose what they like to watch from more than 700 hours of popular TV shows and movies, which is why Luminopia One’s compliance in clinical trials was twice as high as treatment with an eye mask. And, Luminopia’s recommended duration of use is one hour per day, six days per week, which meets the American Academy of Pediatrics’ screen time guidelines for young children.
Luminopia One works by stimulating and training the visual function of the weak eye by having the patient watch a specially processed TV program or movie in a VR headset. The software algorithms of Luminopia One modify the images received by each eye in real time to varying degrees, depending on the patient’s vision, and present them in a different way to each eye.
Unlike eye masks or eye drops, Luminopia One improves the vision of amblyopic patients in two different ways, achieving a dual effect treatment. On the one hand, binocular masking is applied while decreasing the contrast, sharpness and saturation of the image in the more sighted eye and enhancing the sharpness, contrast and saturation of the image received by the amblyopic eye. On the other hand, binocular masking removes a portion of the image from each eye and teaches the brain to combine the images input from both eyes. This is done to allow the brain to rebalance the image input from both eyes, forcing the brain to use both eyes to synthesize a complete image and train the eyes to work together. The treatment uses a child-friendly VR headset to display the images, enabling the treatment to take place in an undisturbed, controlled environment. The images within the helmet are also projected using optical infinity, so there is no need to worry about their close-up irritation to the eyes.
So how to access the Luminopia One service?
First, a doctor will send an e-prescription to PhilRx, Luminopia’s retail pharmacy partner, without having to think about anything else such as inventory, payment, etc. PhilRx will send a text message to the patient to help complete the enrollment and guide them through checking their insurance coverage, and then collect the fee, send the patient the VR headset and send an access code to start the treatment. And, once treatment is started, PhilRx will share the patient’s access code with the physician, who can then use the Luminopia Adherence Portal to track the patient’s amblyopia treatment, virtually monitoring weekly and overall adherence trends.
Luminopia’s current clinical partners include Boston Children’s Hospital, The Ohio State University, Duke Health, UCLA Stan Eye Institute and more. In addition, Luminopia has partnered with several leading experts in pediatric ophthalmology and neuroscience, including David Hunter, MD, Chief of Ophthalmology and Richard Robb Chair of Ophthalmology at Children’s Hospital Boston; Gil Binenbaum, Chief of Ophthalmology at Children’s Hospital of Philadelphia; and Mark Bear, Picower Professor of Neuroscience at the Massachusetts Institute of Technology, among others. To create a more engaging therapeutic experience for children, Luminopia has also partnered with favorite entertainment companies such as Sesame Street, Nickelodeon, PBS Kids and others to deliver even better, category-rich television programming.
FDA Approved, 86% of Pediatric Patients See Improved Vision After Treatment
In October 2021, Luminopia One was approved by the U.S. Food and Drug Administration (FDA) through the De Novo pathway, making it the first FDA-approved treatment for binocular amblyopia for children ages 4-7 and the first FDA-approved digital therapeutics for the treatment of neurovisual disorders. Luminopia One is currently available.
Luminopia One is rooted in cutting-edge neuroscience and builds on decades of cutting-edge research by leading clinicians and neuroscientists at Boston Children’s Hospital and MIT. Currently, Luminopia One technology has been tested in three clinical trials with more than 200 pediatric patients in more than 20 U.S. hospitals and research institutions. This includes a gold-standard, randomized, controlled Phase 3 trial that demonstrated the safety and efficacy of Luminopia One therapy in children ages 4-7.
Data from the clinical study showed that patient compliance with Luminopia One therapy was better, with 85% of patients complying with six days a week, one hour a day for 12 weeks, 86% of pediatric patients experienced improved vision after treatment, and 94% preferred Luminopia One, whereas compliance with eye wear in children often hovered below 50%. No serious adverse events were reported in the Luminopia One pivotal trial.After 12 weeks, patients treated with Luminopia One showed a mean improvement of 1.8 lines on the standardized visual acuity scale, compared to only 0.8 lines in the control group, who were treated only with corrective lens wear. This phase 3 pivotal trial is the first successful, randomized, controlled trial of a new amblyopia treatment in nearly 15 years, and the results of the trial were previously published in Ophthalmology (eye).
On June 27, 2023, Luminopia closed a $16 million Series A financing round led by US Venture Partners, an early-stage venture capital firm focused on information technology and healthcare, with participation from The Vertical Group, ShangbayCapital, Broadfin Advisors. These funds will support Luminopia’s full commercialization of Luminopia One, furthering its mission to “create a new treatment for the 15 million Americans living with neuro-vision disorders”!