CAMBRIDGE, Mass.--(BUSINESS WIRE)--Luminopia, Inc., a commercial-stage company pioneering a new class of treatments for neuro-visual disorders, today announced that the company’s lead product, Luminopia, was named one of TIME’s Best Inventions of 2023.
Luminopia is the first FDA-approved1 digital therapeutic for a neuro-visual disorder, indicated to improve vision in children, aged 4-7, with amblyopia (lazy eye). Amblyopia is the leading cause of vision loss in children, affecting 3% of children worldwide. Traditional treatments include glasses, eye-patches, and blurring (atropine) eye drops, but these options leave a significant unmet need due to poor compliance, residual vision loss, and negative psychosocial impacts.
“Despite the pace of technological advancements today, there has been little innovation in the treatment of lazy eye for several decades. Eye-patching is still the primary means of therapy, which most kids struggle with – and as a result, 79% of kids still have residual amblyopia after treatment. Given the clear unmet need, we set out to develop a treatment that would leverage cutting-edge technology to not only improve vision but also make therapy simple and engaging for kids and their families,” said Scott Xiao, Co-Founder and CEO of Luminopia. “Luminopia is the first virtual reality-based therapeutic to receive FDA approval for a medical condition, and we are honored that TIME has recognized Luminopia as a groundbreaking invention.”
With Luminopia, children can choose from up to 700 hours of popular TV shows or movies to watch in a virtual reality (VR) headset to improve their vision. Therapeutic algorithms modify the selected videos in real-time within the headset to promote weaker eye usage and encourage patients’ brains to combine input from both eyes. Unlike conventional treatments like eye-patching and blurring (atropine) eye drops which just penalize the stronger eye, Luminopia uses a dual-acting mechanism that treats the amblyopic eye and teaches patients to use both eyes together in a unique, binocular manner.
Luminopia’s ability to improve vision in children has been demonstrated through three confirmatory clinical trials, including a Phase 3 randomized controlled trial where patients treated with Luminopia gained 1.8 lines of vision on an eye chart in 12 weeks. Importantly, median adherence to Luminopia in the Phase 3 trial was 88%, double that of patching. Luminopia has been prescribed by more than 200 providers at top children’s hospitals and academic institutions, and more than 1,000 patients have been treated with the therapy during its pilot launch phase.
To compile the Best Inventions of 2023 list, which features 200 extraordinary innovations changing people’s lives, TIME solicits nominations from its editors and correspondents around the world through an online application process, paying special attention to growing fields—such as AI, green energy, and sustainability. Each contender is then evaluated on a number of key factors, including originality, efficacy, ambition, and impact.
Of the new list, TIME’s editors shared: “The result is a list of 200 groundbreaking inventions (and 50 special mention inventions)—including the world's most powerful supercomputer, a game-changing entertainment venue, and a new shape—that are changing how we live, work, play, and think about what’s possible.”
See the full list of TIME’s Best Inventions of 2023 here: time.com/best-inventions-2023
To learn more about Luminopia, visit luminopia.com.
Luminopia is the first FDA-approved1 digital therapeutic for a neuro-visual disorder, indicated to improve vision in children with amblyopia. With Luminopia, patients choose TV shows and movies to watch from a selection of 700+ hours of popular, engaging, and educational content. Dual-acting algorithms modify the selected videos in real-time within a virtual reality (VR) headset to promote weaker eye usage and encourage patients’ brains to combine input from both eyes. Unlike conventional treatments like eye-patching, blurring (atropine) eye drops, and other digital therapies, which just penalize the stronger eye, Luminopia teaches patients to use both eyes together in a unique, binocular manner.
Luminopia has been validated through a series of clinical trials, including a Phase 3 pivotal trial that demonstrated its safety and efficacy in children aged 4-7 with amblyopia. The Phase 3 pivotal trial was the first successful, randomized, controlled trial of a novel amblyopia treatment in almost 15 years, and the results were published in Ophthalmology, the journal of the American Academy of Ophthalmology. Pilot studies have also shown efficacy in older children and adolescents, where eye-patching and blurring (atropine) eye drops are largely ineffective.
Indications for Use for Luminopia
Luminopia is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs), which are compatible with the software application. Luminopia is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia is intended for both previously treated and untreated patients; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. Luminopia is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia therapy. Luminopia is intended for prescription use only, in an at-home environment.
Amblyopia, commonly referred to as lazy eye, is a medical condition characterized by reduced vision that cannot be explained by structural abnormalities alone. Often diagnosed in young children, amblyopia is driven by neurological deficits, which suppress the visual input from the weaker eye, leading to long-term deficits in vision. Amblyopia can be caused by a variety of different factors, including a refractive error such as nearsightedness (myopia), farsightedness (hyperopia), or astigmatism; strabismus, which is when one eye drifts; or rarely, cataracts or cloudiness in the lens. Amblyopia is the most common cause of vision loss in children and affects 3% of children worldwide. In addition, amblyopia is associated with a higher risk of lifetime bilateral vision loss and several mental health conditions including ADHD, anxiety, and depression. Current treatment options of eye-patching and blurring (atropine) eye drops are monocular approaches, which do not train the eyes to work together and are not sufficient in many cases to restore full visual function. Poor patient compliance and social stigmas also present significant challenges with existing treatment options.
About Luminopia, Inc.
Luminopia, Inc. is pioneering a new class of treatments for significant neuro-visual disorders. Luminopia is committed to creating digital therapeutics that are both rigorously evaluated for FDA approval and genuinely engaging for patients. The company is an Innovation Partner of Boston Children’s Hospital* and developed its lead product to improve vision in children with amblyopia, the leading cause of vision loss among children. For more information, visit luminopia.com.
LUMINOPIA is a trademark of Luminopia, Inc.
*Boston Children’s Hospital holds equity in Luminopia. David Hunter, MD, Ph.D., Ophthalmologist-in-Chief at Boston Children’s Hospital is an advisor to Luminopia and holds equity.
1 De Novo granted in Oct 2021, 510(k) clearance in Nov 2022 to expand the list of compatible headsets.