Luminopia: Treating Lazy Eye with Television

Addressing Amblyopia: A Novel Treatment Approach

A diagnosis of lazy eye, clinically known as amblyopia, in childhood traditionally presents limited treatment options. These commonly include the use of eye patches, eye drops, or corrective lenses. However, a potentially groundbreaking alternative is on the horizon, pending FDA clearance: television viewing through a specialized system.

Introducing Luminopia and its Origins

Luminopia, a startup comprised of four individuals led by Scott Xiao and Dean Travers, is pioneering this innovative approach. The company was founded six years ago while Xiao and Travers were undergraduate students at Harvard University. Their inspiration stemmed from a classmate’s personal experience with the challenges of amblyopia.

Amblyopia is the most prevalent cause of vision loss in children, impacting approximately three out of every 100 kids.

Understanding the Development of Lazy Eye

The condition typically develops early in life when an imbalance arises, causing one eye to struggle to function in sync with the other. This can be due to disparities in muscle strength, significant differences in visual acuity between the eyes, or an obstruction to clear vision, such as a cataract.

Over time, the brain prioritizes the stronger eye, leading to the weakening of the other, and potentially resulting in permanent vision impairment in severe instances.

Luminopia’s Unique Solution

Unlike conventional treatments, Luminopia’s solution involves children watching television programs through a virtual reality (VR) headset. The content is subtly altered, as the company has secured licensing agreements with prominent providers like Sesame Workshop, Nickelodeon, DreamWorks, and NBC, offering over 100 hours of modified programming.

These alterations may include adjustments to contrast levels or the selective removal of image components, designed to stimulate and strengthen the weaker eye, encouraging it to work in coordination with the stronger one.

“We’re actually altering the image parameters in real time, with the goal of promoting weaker eye usage and encouraging patients’ brains to combine input from both eyes,” explains Xiao.

Clinical Trial Results

In September, the company released the findings of a randomized controlled trial involving 105 children. All participants consistently wore their prescribed glasses, while 51 also engaged with Luminopia’s modified TV shows for one hour, six days a week, over a 12-week period.

The results indicated that children in the treatment group experienced an average improvement of 1.8 lines on a standard eye chart, compared to 0.8 lines in the control group. Notably, some children demonstrated improvements of two or more lines during the 12-week follow-up.

The study’s findings were published in the journal “Ophthalmology.”

Company Growth and Investment

Despite its small size – currently consisting of just four employees – Luminopia has successfully raised approximately $12 million in funding. Investors include Sesame Ventures, the venture capital arm of Sesame Workshop, and prominent angel investors such as Robert Langer, a co-founder of Moderna (now serving on Luminopia’s board of directors), and Jeffrey Dunn, the former president and CEO of Sesame Workshop.

Addressing Treatment Adherence

Luminopia’s approach distinguishes itself by tackling a common challenge in amblyopia treatment, and healthcare in general: ensuring patient adherence to prescribed regimens.

Research suggests that maintaining consistent adherence to lazy eye treatments can be difficult. One study surveying 37 families in Saudi Arabia revealed that children completed only about 66% of their prescribed patching time. Reasons cited included social stigma, discomfort, and outright refusal to wear the patch.

A 2013 study published in “Investigative Ophthalmology & Visual Science” found that children skipped patching on approximately 42% of days.

A Consumer-Centric Approach to Healthcare

Luminopia’s founders prioritized addressing the adherence problem, drawing inspiration from the consumer product industry. “We’ve always seen such a huge gap in the experience of things in the consumer world, where things are so thoughtful and so delightful, and healthcare where so often we see poor experiences that lead to low adherence,” says Travers.

The appeal of watching television is undeniable for children, as Xiao points out. The trial results support this notion, with participants completing 88% of the required TV viewing minutes. Furthermore, 94% of parents expressed a high likelihood of choosing Luminopia’s treatment over traditional eye patching.

Data and FDA Approval

Crucially, securing data and obtaining FDA approval are essential to validate the effectiveness of this “delightful” treatment and overcome adherence challenges. Luminopia’s recent trial builds upon a previous single-arm pilot trial conducted at nine sites with 84 participants. The initial phase of that pilot trial, involving 10 children, demonstrated a 78% completion rate of prescribed treatment minutes and vision improvements equivalent to about three lines on a standard eye chart. These findings were published in “Scientific Reports.”

Precedent in Digital Therapeutics

Luminopia is not the first company to explore game- or fun-based treatments for medical conditions. The FDA has shown some openness to such proposals.

Akili Interactive received FDA approval in June 2020, through the De Novo pathway, for a video game designed to treat ADHD in children. This marked the first instance of the agency approving a video game as a medical treatment. Akili Interactive has secured approximately $301.1 million in funding, according to Crunchbase.

Path to Market and Future Outlook

Akili’s success with EndeavorRx provides a potential roadmap for Luminopia. Both companies offer prescription-only therapeutic services without direct predecessors. Luminopia intends to follow the De Novo pathway in its pursuit of FDA approval this year, having submitted data from its pivotal trial last March.

“We are anticipating a decision by the end of the year, and provided it’s a positive decision, we’re looking to launch the product early next year,” Xiao states.

*This article has been updated to reflect the timing of Luminopia’s product launch. Xiao clarified his earlier quote, adding that if FDA clearance is received, the company will launch the product early next year.