NovaSight Announces Successful Results of Pivotal Amblyopia Treatment Trial

NovaSight announced positive pivotal data from its multicenter, randomized, controlled trial of CureSight, an eye-tracking based, digital treatment device for amblyopia (lazy eye). The study, which randomized 103 participants aged 4 to 9, compared the improvement in visual outcomes achieved by CureSight digital treatment versus eye patching—the current gold-standard-of-care treatment. This is the first-ever pivotal study in which a digital device was shown to be noninferior to eye patching for amblyopia treatment in children.

In addition to achieving the noninferiority primary endpoint, the topline analyses from the pivotal study demonstrated that Best Corrected Visual Acuity (BCVA) improvement at week 16 was larger in the treatment group compared to the patching control group. In addition, a significant stereo acuity improvement was observed in both groups. No serious adverse events were observed in either treatment arms (CureSight or patching) and all non-serious adverse events were transient and self-limiting.

The study also evaluated adherence and patient satisfaction. The mean adherence to CureSight use during the study among subjects evaluated at the week 16 visit (N=43) was 93%, as measured by the CureSight’s eye tracking system. In addition, 93% of parents reported that they are likely or very likely to choose the CureSight digital treatment over patching.

The pivotal clinical study was conducted in six medical centers.

“We are delighted to have completed the CureSight study and further validate its safety and effectiveness as measured by visual acuity and stereoacuity improvement in comparison to patching and with a high safety profile and user satisfaction. Eye patching is effective when patients are compliant, however, patching is often associated with insufficient adherence due to the discomfort it brings to the patient and the social stigma that many children experience when wearing a patch,” NovaSight CEO Ran Yam said in a company news release. “The success of the CureSight study is a critical step toward bringing this treatment for lazy eye to children around the world and to potentially modernizing the standard of care.”

CureSight is a digital device that trains the visual system to use both eyes simultaneously, while the user watches any streamed video content through red-blue treatment glasses. Using sophisticated algorithms and eye-tracking technology, CureSight blurs the center of vision of the image that is shown to the strong eye using real-time image processing. This encourages the brain to complete the image fine details from the amblyopic eye image and trains the two eyes to work as a team. The device is designed to be used at home, and it shares treatment reports with caregivers via a cloud portal. “Innovative solutions that make amblyopia treatment easier for patients to access and clinicians to prescribe and evaluate effectiveness are welcome and increasingly necessary,” said Michael Repka, MD, MBA, Professor of Ophthalmology at Johns Hopkins University.

NovaSight has initiated a Series B financing round in addition to the $20 million the Israeli startup raised to date. Following on the recently granted CE mark approval for CureSight in Europe, completion of the CureSight pivotal trial represents a significant step forward to securing US FDA clearance. With three unique CPT codes for the CureSight treatment already effective since January 2022, NovaSight is poised to take the next step soon with the submission of its application for 510(k) clearance of the device.

NovaSight also announced that, in addition to the CureSight, its CE marked EyeSwift^Pro system – a comprehensive eye-tracking based visual assessment system, which has a powerful portfolio of vision protocols such as myopia management and amblyopia monitoring – would be the subject of discussions with FDA regarding the premarket pathway to commercialization in the U.S. The EyeSwift^Pro is the successor of the current generation EyeSwift device which is distributed globally by EssilorLuxottica.