Oct. 12, 2022
NovaSight, a pediatric-focused eyecare company, announced that the U.S. Food and Drug Administration (FDA) cleared CureSight, a digital therapy device for amblyopia (lazy eye).
CureSight is an eye-tracking-based system aimed at improving visual acuity and stereo acuity by training the visual system to use both eyes simultaneously.
The clearance was based on visual outcomes data from a multicenter, randomized, controlled trial in which 103 participants aged 4 to <9 were randomized to CureSight or eye patching—the current gold-standard-of-care treatment. This was the first-ever pivotal study in which a digital device was shown to be non-inferior to patching for amblyopia treatment in children. The study was conducted in six medical centers in Israel.
Randomized Controlled Trial
In addition to achieving the noninferiority primary endpoint, the top-line analyses from the pivotal study demonstrated that the Best Corrected Visual Acuity (BCVA) improvement at week 16 was larger in the treatment group compared to the patching control group. Out of the patients who reached the 16-week visit, 79 percent in the CureSight group had a BCVA improvement ≥ 2 lines in their amblyopic eye versus 61 percent of patients in the patching group.
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 percent. In addition, 95 percent of parents reported that they are likely or very likely to choose the CureSight digital amblyopia treatment over patching. 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.
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“Availability of a dichoptic digital treatment of amblyopia that matches the effectiveness of eye patching will help our patients have an alternative that also helps them deal with social and compliance challenges often associated with occlusion therapy. This will help foster a more positive feeling about amblyopia treatment,” said Michael Repka, MD, MBA, a professor of ophthalmology at Johns Hopkins University.
Eye Tracking Technology
CureSight trains the visual system to use both eyes simultaneously, while the user watches any streamed video content of choice through red-blue treatment glasses. Using 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 according to the momentary eye gaze. This encourages the brain to complete the image’s 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 web portal.
The CureSight web portal allows ECPs to monitor patient treatment progress and compliance. Additionally, a nationwide Monitoring Center provides comprehensive, beginning-to-end physician and patient support. Directed by practicing ophthalmologists and supported by a team of certified ophthalmic professionals and patient engagement specialists, the Monitoring Center services include compliance monitoring, troubleshooting, billing and technical support.
“Our study showed that CureSight improves both visual acuity and binocularity in the comfort of the patient’s home, with high adherence and satisfaction. The potential for CureSight to be a standard-of-care-changing technology has increased exponentially with this milestone FDA clearance,” said Ran Yam, NovaSight co-founder and CEO. “The standard-of-care eye patching treatment, which hasn’t changed for centuries, can be effective if the child adheres to the treatment. However, self-esteem issues and discomfort can limit compliance to below 50 percent, and this results in patients suffering from reduced vision in one eye, limited coordination skills and impaired depth perception in adulthood. We are gratified that FDA clearance, together with the three unique CPT codes assigned by the American Medical Association (AMA) earlier this year, will make access to CureSight possible for patients whose future vision and eye health depend on the treatment that they receive in their early years,” he added.