Scott Xiao and Dean Travers were freshman at Harvard when a computer science project put them on a path to leave the ivy league, and start their own digital therapeutics company.
Luminopia, the company Xiao and Travers founded in 2015, is now fueled by some powerful partnerships, and is on track to bring to market a virtual reality software application to treat amblyopia, better known as lazy eye. The real genius of the technology is that it asks children with the condition to do something they actually want to do — watch television shows and movies.
With Luminopia One, patients watch visually modified shows and movies as treatment. Therapeutic algorithms are applied in real-time to patient-selected video content to promote weaker eye usage and encourage patients’ brains to combine input from both eyes, and treatment is delivered using commercially available VR headsets. FDA is currently reviewing Luminopia One via the de novo pathway, and if approved, it would be the first digital therapeutic approved for a neuro-visual disorder.
Xiao, now CEO at Luminopia, told MD+DI that the idea for Luminopia One, came from talking to a fellow classmate at Harvard about his struggles as a child with lazy eye therapies. They discovered that their classmate was not alone in his experiences with lazy eye therapies, which typically include wearing a patch over the strong eye in an effort to strengthen the weak eye, as well as the use of atropine eye drops — the same kind of drops used to dilate pupils before an eye exam.
From class project to digital therapeutics startup
"We started looking at digital technology as a way to deliver treatments in a more engaging and targeted manner and developed an early prototype of this idea as part of a computer science class that we were in at the time, and reached out to some folks at Boston Children's Hospital," Xiao said.
Xiao still remembers the first time he showed the prototype to David Hunter, MD, PhD, ophthalmologist-in-chief at Boston Children's Hospital reacted the first time they showed him the prototype.
"We were really blown away by his reaction," he said.
Hunter told Xiao and that the biggest problem he deals with on a daily basis as a clinician is trying to get patients and their parents to comply with the prescribed therapy, such as the eye patch and the atropine drops.
"They're always looking for other options, you know, so they're coming to him as a clinician hoping that he has a better approach to treating the condition and he doesn't," Xiao said. "He told us that we were on to something that could really have an impact on patients, and have an impact on his day to day as a clinician."
Hunter now serves as a scientific advisor to the Cambridge, MA-based company. Boston Children's Hospital is also one of the company's innovation partners, along with the Johns Hopkins Wilmer Eye Institute, Children's Hospital of Philadelphia, and the Picower Institute for Learning and Memory at the Massachusetts Institute of Technology (MIT).
Luminopia just emerged from stealth mode with the publication of phase 3 pivotal data in Ophthalmology, the journal of the American Academy of Ophthalmology. The clinical trial represents the first successful randomized controlled trial of a new treatment for lazy eye in more than a decade.
Not only are kids and parents more likely to comply with a solution like the Luminopia One compared to the use of an eye patch and eye drops, but most current therapies for lazy eye are monocular solutions designed to only target one eye, Xiao explained.
"They penalize the stronger eye and hope that that's enough to get your weaker eye to become stronger, but they don't actually teach patients how to take input from both eyes," he said.
The Luminopia One, on the other hand, is designed to encourage patients to combine input from both eyes to view the whole image.
"It's that new mechanism that also makes us believe that we will see better long-term retention of benefits," Xiao said.
Let me tell you how they got, how they got to Sesame Street
Luminopia has also partnered with leading media companies to offer popular, engaging, and educational content for children, from familiar names like Sesame Workshop (the creators of Sesame Street) and Nelvana through its VR software application. If approved by FDA, Luminopia One will be prescribed by an eye care professional for one hour a day, six days a week, for 12 weeks. Continued treatment may be prescribed depending on an individual patient’s response to treatment.
Xiao said that when the company approached Sesame Workshop about using its existing content and repurposing it in Luminopia One to treat children with amblyopia, Sesame not only said yes, but also saw it as an investment opportunity for its venture capital arm, Sesame Ventures.
Phase 3 study design and results
In the pivotal study, children who received Luminopia One plus glasses (the treatment group), experienced a statistically significant improvement in Best Corrected Visual Acuity (BCVA; the primary endpoint) compared to those who wore glasses alone (the control group).
Participants were recruited at 21 U.S. academic and community sites, including the Cleveland Clinic, UCLA Jules Stein Eye Institute, Duke Eye Center, Ann & Robert H. Lurie Children’s Hospital of Chicago, Texas Children’s Hospital, and Children’s Hospital of Philadelphia. A total of 105 patients were enrolled in the study—51 were randomized to the treatment group and 54 to the control group. An interim analysis was planned and conducted after 105 participants had completed the primary endpoint visit at 12 weeks. At the interim analysis, the difference between groups in weak eye BCVA improvement was significant (1.0-line, p=0.0011, 96.14% CI: 0.33-1.63 lines). No serious adverse events were reported.
The study showed:
- 1.8-line improvement in BCVA in the weak eye, from baseline to the 12-week visit (95% CI: 1.4-2.3 lines, N=45) in the treatment group
- 0.8-line improvement (95% CI: 0.4-1.3 lines, N=45) in the control group
- Proportion of participants who improved 2 lines or more in BCVA in the weak eye, from baseline to the 12-week visit, was greater in the treatment group (62%) compared to the control group (33%, p=0.006).
- 84% of participants in the treatment group had a history of patching or atropine treatment, but the efficacy of Luminopia One remained robust in this subgroup (difference between groups: 1.0-line, p=0.005).
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.
A link to the publication, “Randomized Controlled Trial of a Dichoptic Digital Therapeutic for Amblyopia,” can be found here: https://www.aaojournal.org/article/S0161-6420(21)00682-5/fulltext.
Digital therapeutics as a new class of treatment
As MD+DI has previously reported, the digital therapeutics market has gone absolutely gang busters this year.
Back in 2014, Omada Health became one of the first companies to use the term "digital therapeutics" in an effort to differentiate itself from a rapidly expanding field that included wellness applications and other technologies that have come to fall under the broader digital health banner. The term stuck, and a growing number of companies are latching onto the digital therapeutics label.
The main difference between digital therapeutics and other sectors within digital health is that digital therapeutics are generally expected to be evidence-based, regulated technologies designed to trigger changes in patient behavior. Digital health products are not necessarily evidence-based or regulated.
With so much activity happening as of late in the digital therapeutics market, here is a summary of just some of the recent developments in the space:
- Swing Therapeutics, a new San Francisco, CA-based digital therapeutics company, is taking a "swing" at fibromyalgia with an exclusive license from the University of Manitoba, a breakthrough device designation from FDA, VC funding, and the launch of a real-world study.
- San Francisco, CA-based Woebot Health closed a $90 million series B funding round, bringing total investment in the company to $114 million. Woebot says it has created relational technologies that underpin a new generation of digital therapeutics and tools for mental health. The company’s relational agent, Woebot, is designed to quickly form a bond with users and deliver human-like therapeutic encounters that are psychologically related, responsive to a person’s dynamic state of health, and targeted using multidisciplinary tools.
- San Francisco, CA-based Mahana Therapeutics, a company developing a prescription digital therapeutic for irritable bowel syndrome that employs the use of cognitive-behavioral therapy, recently raised $61 million in a series B round. The company has raised about $81 million since its inception two years ago.
- MedRhythms secured $25 million in series B funding to advance its digital therapeutics platform. The Portland, ME-based company is developing prescription digital therapeutics solution that use sensors, software, and music to measure and improve walking for patients with a neurologic injury or disease.
- Berlin, Germany-based Dopavision closed a €12 million series A round in July to fund the clinical development of MyopiaX, its lead digital therapeutic in childhood myopia, with the goal to demonstrate its safety and efficacy in clinical studies.
- Dario Health has also made a name for itself in the digital therapeutics field. New York, NY-based Dario provides adaptive, personalized experiences that drive behavior change through evidence-based interventions, intuitive, clinically proven digital tools, high-quality software, and coaching to help individuals improve health and sustain meaningful outcomes. The company secured $28.6 million in a private placement last year.
Another trend MD+DI has been tracking is the increasing number of medtech companies going public via a special-purpose acquisition company (SPAC), and there have certainly been a fair number of SPAC mergers involving digital therapeutics companies. The most recent example of this is Pear Therapeutics. Pear was founded in 2013, and has three FDA-cleared prescription digital therapeutic (PDT) products — reSET and reSET-O, and Somryst.