CONN HASTINGS EXCLUSIVE, NEUROLOGY, OPHTHALMOLOGY
Luminopia, a company based in Cambridge, MA, has developed Luminopia One, a visual content system that aims to treat amblyopia, also known as ‘lazy eye,’ in young children. The condition is caused by neurological deficits that typically affect vision in one eye.
At present, the condition is treated using corrective glasses, eye patches, or eye drops, none of which young children are big fans of. The Luminopia One system is different, and involves kids wearing a standard virtual reality (VR) headset, through which they watch TV shows or movies for one hour per day. These include well-known shows, such as those from Sesame Workshop. The system delivers different images to each eye, promoting weaker eye use and forcing the eyes to work better together.
The system aims to be fun for children, and therefore increase their compliance with the treatment. Luminopia recently announced positive results for a phase III trial of the system. Medgadget had the opportunity to speak with Scott Xiao, CEO at Luminopia, about the system and the recent trial.
Conn Hastings, Medgadget: Please give us an overview of amblyopia and its consequences.
Scott Xiao, Luminopia: Amblyopia is the most common cause of vision loss in children and young adults, affecting 3% of this population worldwide. Most people know amblyopia as “lazy eye” and think of it as a physical eye turn, but amblyopia is actually characterized by neurological deficits in the visual cortex that result in worse vision in one eye. Without proper treatment, amblyopia can result in permanent vision loss, increase the risk of blindness, and hinder educational attainment. It is often diagnosed in young children, commonly ages 4-7.
Medgadget: How is the condition currently treated? How is this suboptimal?
Scott Xiao: Typically, amblyopia is treated with a combination of corrective glasses and patching and/or blurring (atropine) eye drops in the stronger eye to overcome the preference in the brain for that eye and strengthen vision in the weaker eye. As you can imagine, patient adherence to these treatment options is a significant challenge. It is difficult to get young children to wear a patch for many hours each day, and children often find eye drops objectionable. Further, recent research has questioned whether traditional approaches of treating amblyopia, through monocular means which do not train the eyes to work together properly, are sufficient for restoring full visual function.
Medgadget: Please give us an overview of Luminopia One and how someone would use it.
Scott Xiao:Luminopia One allows patients to watch TV shows or movies as treatment for amblyopia. To provide patients with a broad library of popular content to choose from, we’ve partnered with a number of leading media companies, including Sesame Workshop. We also teamed up with leading clinicians and researchers at Boston Children’s Hospital and the Massachusetts Institute of Technology to develop a series of software algorithms which modify the videos in real-time into therapeutic visual stimuli. The content is then delivered using an off-the-shelf virtual reality (VR) headset, which allows us to deliver different images to each eye.
Patients in our trial used the treatment 1 hour per day, 6 days per week, for 12 weeks. We anticipate that many patients will continue to use the treatment for several months to fully treat their amblyopia, depending on each patient’s particular condition. If approved by the FDA for use, Luminopia One would be the first de novo digital therapeutic for any neuro-visual disorder.
Medgadget: How does digital content help to address amblyopia?
Scott Xiao: Luminopia One reduces the contrast of the video images presented to the stronger eye and superimposes dichoptic masks on the video images presented, promoting weaker eye usage and encouraging patients’ brains to combine input from both eyes. This unique, binocular approach to treatment is one of the key advantages of our device compared to current modalities. The other major advantage is high compliance – by creating a product experience that is genuinely engaging for patients to use, we have observed adherence rates in our trials that are almost double those observed for patching.
Medgadget: How did the idea for the technology come about?
Scott Xiao: My cofounder and I met at Harvard and started working on this idea after learning about amblyopia from one of our friends who suffered from the condition as a child. Our friend told us all about his struggles with the existing treatment options, and we were shocked that antiquated methods like patches and eye drops were the only therapies available for such a prevalent condition. As part of a computer science project, we developed an early prototype of the Luminopia One device and showed it to the Ophthalmologist-in-Chief at Boston Children’s Hospital, and his promising feedback inspired us to start a company to bring this product to patients. He became our first scientific advisor, and we also became an Innovation Partner of Boston Children’s Hospital later down the road.
As young founders, one of our core tenets from the beginning has been to work with the best people in each field. We are proud that over the past few years, our amblyopia treatment has been studied at some of the top academic institutions in the country, including the Cleveland Clinic, UCLA Jules Stein Eye Institute, Duke Eye Center, and Children’s Hospital of Philadelphia.
Medgadget: Please give us an overview of the clinical results observed with the technology so far. When do you anticipate that the technology could be approved and available?
Scott Xiao: When we started Luminopia, we committed ourselves to following the rigor of a typical pharmaceutical development path, and we’ve done that over the past few years through a series of clinical trials evaluating the safety and efficacy of Luminopia One for the treatment of amblyopia in children. These studies culminated in a successful Phase 3 pivotal trial that was recently published in Ophthalmologyand has been submitted to the FDA to support a potential de novo premarket approval of Luminopia One. We are anticipating a decision by the FDA before the end of the year.
The Phase 3 trial was conducted at 21 leading academic and community sites in the U.S. A total of 105 patients were enrolled in the study—51 were randomized to the treatment group and 54 to the control group. After 12 weeks of treatment, patients in the treatment group had a 1.8-line improvement in weak eye vision, compared with a 0.8-line improvement in the control group. The difference between groups in weak eye vision improvement was significant (1.0-line, p=0.0011). No serious adverse events were reported.
The study also evaluated adherence and patient satisfaction, as these are challenges with current amblyopia treatments. The median adherence for Luminopia One in the study was 88%, substantially higher than studies have shown for patching. Patient satisfaction was evaluated using the Net Promoter Score (NPS) metric, and Luminopia One’s NPS was +65, comparable to popular consumer products like the iPhone.
We are excited to say that this is the first successful randomized controlled trial of a novel amblyopia treatment in more than a decade, and the results provide strong evidence supporting a potential new therapy for millions of patients. It is also the first randomized trial to demonstrate efficacy of a novel, binocular approach to treating amblyopia in children.
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