Amblyopia

Luminopia meets rigorous criteria set by Highmark's New Technology Advisory Committee (NTAC) and receives a positive coverage determination from the plan CAMBRIDGE, Mass., Aug. 6, 2024 /PRNewswire/ -- Luminopia, Inc., a digital health company pioneering a new class of treatments for neuro-visual disorders, announced today that Highmark, who through its subsidiaries and affiliates provides health insurance to 6.9 million members in Pennsylvania, West Virginia, Delaware, and New York, has approved Luminopia's FDA-approved1 therapy for children with amblyopia for coverage. Continue Reading Luminopia is a dual-acting, binocular therapy for amblyopia that allows children to watch TV as treatment instead of wearing a patch. Proprietary therapeutic algorithms modify images and present them differently to each eye inside a VR headset, encouraging both eyes to work together while treating the underlying disease. Highmark follows rigorous criteria through its New Technology Advisory Committee (NTAC) to evaluate clinical evidence and determine the medical necessity of new digital health technologies. The unmet need left by traditional amblyopia treatments, along with the substantial body of clinical data supporting Luminopia's efficacy and safety, provided the backing for this positive coverage decision by Highmark's NTAC. Luminopia is a dual-acting, binocular therapy for amblyopia, the leading cause of vision loss in children, that allows kids ages 4-7 to watch TV rather than wear an eye patch or use blurring atropine drops. Both eye-patching and atropine drops are monocular treatments that only block vision in the stronger eye and are associated with poor treatment compliance and residual vision deficits in over 50% of patients. Luminopia's proprietary therapeutic algorithms modify media content and present it differently to each eye inside a VR headset, encouraging both eyes to work together while treating the underlying disease. Luminopia significantly improves vision by 12 weeks as demonstrated in multiple clinical trials with a dose of only 1 hour a day, 6 days a week. The therapy is being prescribed by physicians at top eye institutes and children's hospitals across the U.S. "We appreciate Highmark's thoughtful and rigorous approach to assessing new technologies, which can serve as a model for other health plans interested in bringing innovative therapies to their members. Meeting the Highmark NTAC's high standards for clinical evidence is a significant validation of our technology and the impact it can have on patients with amblyopia," said Scott Xiao, co-founder and CEO of Luminopia. "We are committed to making our treatment as accessible as possible for patients in need, and this approval brings us closer to our mission of transforming the standard of care for amblyopia." Learn more about Luminopia at luminopia.com. 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. About Luminopia 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 1100+ 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. For more information, visit . 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. About Amblyopia 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. ¹ De Novo granted in Oct 2021, 510(k) clearance in Nov 2022 to expand the list of compatible headsets. LUMINOPIA is a trademark of Luminopia, Inc. SOURCE Luminopia

Findings from a real-world patient registry presented at recent scientific meetings, including American Association for Pediatric Ophthalmology and Strabismus, Association for Research in Vision and Ophthalmology, and European and International Strabismological AssociationPatients with matched baseline characteristics to the Luminopia Phase 3 clinical trial achieved similar vision improvement and treatment adherence as clinical trial participants CAMBRIDGE, Mass., June 18, 2024 /PRNewswire/ -- Luminopia Inc., a digital health company pioneering a new class of treatments for neuro-visual disorders, today announced that real-world data (RWD) from the Patients Using Prescription Luminopia (PUPiL) Registry™ continues to demonstrate efficacy of the FDA-approved1 therapy in improving vision for children with amblyopia. Continue Reading Derek Sprunger, MD, FAAO, Professor, Indiana University School of Medicine, presenting at the European and International Strabismological Association conference in Toulouse, France. Luminopia's approach to treating amblyopia, or lazy eye, in young children – pairing proprietary therapeutic software with virtual reality (VR) headsets and popular children's TV shows – has been available on the market for over a year following rigorous clinical trials and de novo FDA premarket approval. The data presented at the European and International Strabismological Association conference in Toulouse, France by Derek Sprunger, MD, FAAO, Professor, Indiana University School of Medicine, further support the topline data presented at recent international scientific meetings. Results from the PUPiL Registry were first presented at the American Association for Pediatric Ophthalmology and Strabismus (AAPOS) 2024 annual meeting in April by Euna Koo, MD, Clinical Associate Professor of Ophthalmology, Stanford University and then at the Association for Research in Vision and Ophthalmology (ARVO) 2024 annual meeting in May, by Fatema Ghasia, MD, at the Cole Eye Institute, Cleveland Clinic. This initial registry analysis of 179 patients from 10 clinical sites showed significant improvement in visual acuity after 12 weeks of Luminopia treatment in a broad population. The cohort of patients with similar baseline characteristics to Luminopia clinical trial participants improved by 1.7 lines in 12 weeks and had 83% median treatment adherence, in line with the pivotal trial results. Across the registry, subgroups of patients with respect to amblyopia severity, prior treatment experience, age, and type of amblyopia all showed significant vision improvement after 12 weeks of treatment and no safety events were reported. These outcomes confirm the efficacy of Luminopia in the real world and, importantly, demonstrate its clinical benefit as both a first and second-line treatment. Despite amblyopia being the leading cause of vision loss in children, the traditional therapies of patching and atropine eye drops only block vision in the stronger eye and are associated with poor treatment compliance and residual vision deficits in over 50% of patients. Patients using Luminopia watch popular kids TV shows for 1 hour per day, 6 days per week in a VR headset to improve vision instead of wearing an eye patch. Proprietary software algorithms modify that content in real time via a dual-acting mechanism which encourages the brain to prioritize the weaker eye and use both eyes together. The immersive VR environment minimizes distractions during treatment and ensures images are presented at optical infinity. Summarizing the RWD and Luminopia's efficacy, Dr. Sprunger said, "The analysis of real-world data from the PUPiL registry demonstrates the benefit of digital therapy in improving outcomes for amblyopia. Luminopia's unique mechanism of action, which doesn't just penalize the strong eye but uses dichoptic masking to encourage binocular fusion, is proving to be effective for a broad range of patients. The objectively-measured compliance is quite encouraging and a significant improvement over traditional treatments like patching." "For decades, the standard-of-care treatment for amblyopia has been to patch the stronger eye, but the majority of patients who go through patching are still left with the condition," said Scott Xiao, Luminopia's co-founder and CEO. "Our product can improve outcomes for patients thanks to both our unique mechanism and better patient compliance. This registry data further validates that our therapy is effective, easy for young patients to use, and has significant benefit in the real world." About Luminopia 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 1100+ 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. About Amblyopia 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. SOURCE Luminopia

Prevent Blindness urges House and Senate to quickly pass "Early Detection of Vision Impairments for Children Act" to improve access, diagnosis, and treatment for kids ages 2-17 CHICAGO, May 14, 2024 /PRNewswire/ -- Prevent Blindness, the nation's leading eye health and safety organization, applauds the introduction of the "Early Detection of Vision Impairments in Children (EDVI) Act," in the U.S. House of Representatives and urges the 118th Congress to move swiftly to pass the proposed legislation. Continue Reading Prevent Blindness Logo The EDVI Act, which seeks to establish grants for states and communities to improve children's vision and eye health through coordinated systems of care, is a bipartisan proposal, co-sponsored by Congressional Vision Caucus (CVC) co-chairs, U.S. Representative Gus Bilirakis (FL-12), and U.S. Representative Marc Veasey (TX-33). Companion legislation is expected to be introduced in the U.S. Senate. "As an American who has suffered from poor vision since childhood, I have a first-hand understanding of how critical early detection and treatment is when it comes to ensuring that all children have the best possible start in life," said Rep. Bilirakis. "Our landmark bill will ensure all children get the screening and care they need at the right age by creating the first-ever federally funded program to address children's vision and eye health. This legislation will empower states and communities, like mine, to improve systems of care for our youngest citizens and their families." "Children's vision and eye health is a critical aspect of a child's healthy development that has been overlooked for far too long," said Rep. Veasey, the newly appointed Democratic co-chair of the CVC. "Healthy vision plays a key role in each child's performance in school - when a child cannot see, their education suffers. Texas families and children across the country deserve equitable access to early detection and care for vision issues, whether at school, in the community, or across the healthcare spectrum. The Early Detection of Vision Impairments for Children Act will ensure children, their parents, and their caregivers can access the eye care they need to thrive and succeed." Despite the presence of numerous public health programs that support early childhood development, including children's hearing and oral health, there is currently no federally funded program in the United States that specifically addresses children's vision or that fosters a cohesive and equitable system of eye health for children. "More than one in every four children in America, or roughly 19.6 million, have a vision problem requiring treatment," said Jeff Todd, president and CEO of Prevent Blindness. "We know access to education, screenings, examinations, diagnosis, and treatment are critical to preventing vision loss, and this legislation is an important step in providing children and their families with those services and the healthcare they need and deserve." "Vision plays a critical role in children's physical, cognitive, and social development," said Donna Fishman, director of the National Center for Children's Vision and Eye Health at Prevent Blindness. "Without early detection and treatment, uncorrected vision disorders can impair child development, interfere with learning, and even lead to permanent vision loss." Visual functioning is a strong predictor of academic performance in school-age children. If left untreated, common vision disorders in childhood, such as amblyopia (lazy eye), strabismus (crossed eyes), myopia (nearsightedness), or hyperopia (farsightedness), may continue to affect health and well-being throughout the child's life. Currently, significant disparities exist in children's vision and eye health outcomes and access to eye care across the United States. State laws to address children's vision vary widely in approaches and often lack protocols for referrals to eye care providers and documentation to ensure eye care was received. States may also lack the necessary resources to adequately capture data on rates of received eye care, leading to challenges in addressing existing disparities among demographic sub-populations or in rural or under-resourced communities. Under the EDVI Act, the Health Resources and Services Administration (HRSA) at the U.S. Department of Health and Human Services, will award grants and cooperative agreements for states, communities, and tribes to: Implement approaches (such as vision screenings) for the early detection of vision concerns in children, referrals for eye exams, and follow-up mechanisms; identify barriers in access to eye care; reduce disparities in eye health; and/or develop state-based data collection, surveillance, and performance improvement systems. Resources will also be made available through the Centers for Disease Control and Prevention to establish a national level technical assistance center to provide guidance to any state or community implementing children's vision programs and to advance population health research priorities in children's vision. A broad spectrum of public health organizations support the legislation, including American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Ophthalmic Registered Nurses, Association of Clinicians for the Underserved, Association of Maternal and Child Health Programs, Children's Vision Equity Alliance, Family Voices, Healthy Schools Campaign, National Alliance for Eye and Vision Research, National Association of School Nurses, and the School-Based Health Alliance, among others. Prevent Blindness is asking the public to show support for the EDVI Act and its goal of promoting children's vision and eye health by contacting their Members of Congress and asking them to co-sponsor the EDVI Act. Individuals can contact their Representative by visiting the Prevent Blindness Legislative Action Center. "Implementing the EDVI Act will take a systems-based, coordinated effort among a broad spectrum of stakeholders, including health care professionals, families, patients and the bipartisan leadership of Congress, as we seek to ensure all children have access to the care necessary to avoid preventable vision loss and blindness," concluded Todd. For information on the EDVI Act and Prevent Blindness advocacy efforts, please visit , or contact [email protected]. About Prevent Blindness Founded in 1908, Prevent Blindness is the nation's leading volunteer eye health and safety organization dedicated to fighting blindness and saving sight. Focused on promoting a continuum of vision care, Prevent Blindness touches the lives of millions of people each year through public and professional education, advocacy, certified vision screening and training, community and patient service programs and research. These services are made possible through the generous support of the American public. Together with a network of affiliates, Prevent Blindness is committed to eliminating preventable blindness in America. For more information, visit us at PreventBlindness.org, and follow us on Facebook, X, Instagram, Threads, LinkedIn and YouTube. Sean McBride 202.309.3050 [email protected] Sarah Hecker 312.363.6035 [email protected] SOURCE Prevent Blindness