Dive Brief:

• NovaSight’s digital treatment for amblyopia, also known as lazy eye, has been cleared for use in the U.S. by the Food & Drug Administration.
• NovaSight’s device, branded CureSight, is an eye-tracking-based system designed to train people to use both eyes simultaneously. 
• A randomized controlled trial found the digital device to be as effective as wearing an eye patch, the current gold standard for treatment, in terms of its effect on vision test scores.

Dive Insight:

Children with amblyopia typically wear a patch over their stronger eye for two to six hours a day. Obscuring one eye stimulates the weaker eye, causing vision to improve. The child’s vision can ameliorate in weeks, although treatment may need to continue for as long two years. 

NovaSight developed a different solution to the problem. The patient wears red-blue treatment glasses while watching their choice of streamed video content. Algorithms and eye-tracking technology inform the blurring of the center of vision of the image that is shown to the strong eye. The blurring is done with real-time image processing to encourage the brain to use details from the weaker eye to complete the image.

"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,” Michael Repka, a professor of ophthalmology at Johns Hopkins University, said in a statement.

In a 16-week clinical trial, the weak eye of 79% of patients treated with CureSight improved by at least two lines on the Best Corrected Visual Acuity (BCVA) test, the standard assessment of vision. Sixty-one percent of patients in the patching group experienced a two-line or greater BCVA improvement, causing the study to achieve its primary noninferiority endpoint.

The study found mean adherence to the at-home CureSight treatment was 93% at the week 16 visit. Almost all, or 95%, of the patients said they would likely or very likely choose CureSight over patching.