NovaSight announces FDA clearance of CureSight digital therapy for amblyopia
NovaSight announced in a press release that CureSight, a digital therapy device for amblyopia, has gained 510(k) clearance from the FDA.
According to the release, the device uses eye-tracking technology to train both eyes to work together while the user watches streamed video content. The treatment glasses are designed to replace traditional eye patching and can be used at home.
“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,” Michael Repka, MD, MBA, professor of ophthalmology at Johns Hopkins University, said in the release. “This will help foster a more positive feeling about amblyopia treatment.”
Clearance was based on a multicenter, randomized controlled trial in Israel that included 103 children, aged 4 to 9 years, which found CureSight to be noninferior to eye patching.
Mean adherence to the device at the week 16 visit was 93%, according to the press release, and 95% of parents reported being likely to choose the digital amblyopia treatment over patching.
“Our study showed that CureSight improves both visual acuity and binocularity in the comfort of the patient’s home, with high adherence and satisfaction,” NovaSight co-founder and CEO Ran Yam said in the release. “The potential for CureSight to be a standard-of-care-changing technology has increased exponentially with this milestone FDA clearance.”