NovaSight Announces Publication of CureSight(TM)'s Pivotal Study of One-Year Follow-Up Outcomes

Study Demonstrates That Patients Achieved Long-Term Visual Acuity Gains Following CureSight Treatment

AIRPORT CITY, ISRAEL / ACCESSWIRE / March 13, 2024 / NovaSight, a rapidly growing pediatric-focused eyecare company, is pleased to announce publication of a study demonstrating long-term vision gains achieved with CureSight, the company's digitized, at-home amblyopia (lazy eye) treatment, in the American Journal of Ophthalmology. The study found that children with various types of amblyopia, showed significant improvement in both visual acuity (VA) and stereoacuity following short-term binocular treatment with CureSight, and that the gains were maintained for at least one year. The pivotal Randomized Controlled Trial (RCT), which enrolled 103 participants aged 4 to under 9 years, compared vision and stereoacuity improvement outcomes with CureSight versus eye patching - the current gold-standard-of-care in amblyopia. The pivotal study was carried out in six medical centers. This included Sheba Medical Center, ranked one of the top 10 best hospitals in the world by Newsweek in 2024. This was the first large-scale RCT in which a digital device was demonstrated to be non-inferior to the patching treatment for children with amblyopia.

In this prospective follow-up study, 38 patients out of the 43 patients who were initially treated for 16 weeks with CureSight were reevaluated at 12-weeks post-treatment, and 27 patients were evaluated at one-year post-treatment. At 12-weeks post-treatment, improvement in amblyopic eye VA was maintained with no statistically significant change compared to the end-of-treatment visit. At one year, there was a partial reduction in the amblyopic eye VA gain compared to end-of-treatment but with a statistically significant residual gain of two lines compared to baseline, (0.20±0.14 LogMar Mean, SD). Gains in stereoacuity and binocular VA were significantly maintained compared to baseline at both 12-weeks and one-year post-treatment (p<0.0001), with no change from end-of-treatment (p>0.05).

CureSight is an FDA-cleared and CE-marked eye-tracking-based digital treatment program for amblyopia that is indicated for improvement of both visual acuity (VA) and stereoacuity that is carried out while the child watches any streamed content of their choice on a user-friendly digitized tablet from the comfort of their home. Using complex algorithms and eye-tracking technology, CureSight constantly blurs the center of the image that is presented to the strong eye by real-time image-processing while the image presented to the lazy eye remains sharp. This encourages the brain to complete the image's fine details from the amblyopic eye and improves acuity while enabling the visual system to process both eyes' images simultaneously as the eyes learn to work together as a team.

Real-World Relevance

"This study shows that improvements after 16 weeks of binocular treatment were maintained 52-weeks post-treatment, with amblyopia recurrence rates comparable to those reported in the literature," said Burton J. Kushner, MD, Professor Emeritus in the Department of Ophthalmology & Visual Sciences at the University of Wisconsin, and a member of the CureSight Pivotal Trial Group. "I believe CureSight and its capabilities will help providers like myself engender a positive feeling about amblyopia treatment in our young patients and their caregivers," he added.

Following its FDA clearance in October 2022, NovaSight launched the CureSight Referral Program in the U.S. in early 2023 and experienced great adoption by both eye care providers and patients. Over 250 eye care providers, including both ophthalmologists and optometrists from private clinics and renowned institutions such as Berkely University, Duke University, Cleveland Clinic, Thomas Eye Group and Seattle Children's Hospital, have joined the program, which has already generated more than 650 patient referrals. Post-market data shared by eye care providers of the CureSight Referral Program revealed significant visual acuity and stereoacuity improvement with high compliance and satisfaction rates in a real-world setting.

NovaSight is planning a full commercial rollout in the U.S. in parallel to the commercial launch of CureSight in Europe and China in 2024. To support its commercial and research and development activities, NovaSight has initiated a Series B round with a firm commitment in place by a healthcare-focused venture capital firm to lead the round through a significant investment.

"We are excited to announce that a leading healthcare-focused venture capital firm has made a substantial investment, solidifying their firm commitment to spearhead NovaSight's Series B round funding. NovaSight welcomes further participation from interested investors, as we collectively endeavor to revolutionize the pediatric vision care sector," said Ran Yam, NovaSight CEO and co-founder.

NovaSight will be exhibiting at the 2024 Annual AAPOS (American Association for Pediatric Ophthalmology and Strabismus) meeting April 7-11, and holding a dedicated symposium on April 10, to share the latest updates on CureSight, discuss long-term results of CureSight's pivotal study, and share real-world case studies.

About NovaSight:

NovaSight is an Israeli company that focuses on bringing pediatric vision care into the digital age. Founded in 2016, NovaSight has experienced rapid growth by delivering complete end-to-end eye-tracking-based solutions for accurate assessment and treatment of early vision disorders.

NovaSight offers two flagship products, both ideally positioned for remote diagnostics and home treatment: The CureSight^™ system is an eye-tracking-based treatment for amblyopia intended to replace traditional eye patching. The EyeSwift^®PRO system is a comprehensive portable vision-assessment device that accurately and objectively screens for multiple vision impairments within seconds. Additional pipeline products include the TrackSight® digital solution for myopia (short-sightedness) control, targeted to provide an affordable and accessible solution to help combat the myopia global epidemic.

Contact Information:

Deb Holliday
President, Holliday Communications, Inc.
deb@hollidaycommunications.net
412-877-4519

Jenny Goldman
Marketing Manager
jenny@nova-sight.com

SOURCE: NovaSight

View the original press release on newswire.com.