NovaSight has received FDA clearance for CureSight, a digital therapy device for amblyopia (lazy eye). CureSight is an eye-tracking-based device aimed at improving visual acuity and stereo acuity by training the visual system to use both eyes simultaneously.
The ground-breaking 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 crucial trial to ever demonstrate that a digital device is noninferior to patching for the treatment of childhood amblyopia. The study was conducted in six medical centers in Israel.
The pivotal study's topline analysis showed that the treatment group's BCVA improvement at week 16 was greater than the patching control group's, in addition to demonstrating that the study's noninferiority primary endpoint was met. Out of the patients who reached the 16-week visit, 79% in the CureSight group had a BCVA improvement ≥ 2 lines in their amblyopic eye versus 61% of patients in the patching group.
Additionally, the study assessed patient satisfaction and adherence. When patients were assessed at the week 16 visit (N=43), the mean adherence to CureSight use throughout the research was 93%. Additionally, 95% of parents said they would probably or definitely chose CureSight's digital amblyopia treatment over patching.
Both groups showed a considerable improvement in stereo acuity. No major adverse events were noticed in either of the therapy arms, patching or CureSight, and all mild adverse effects were temporary and self-limiting.
“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.
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. The system uses eye-tracking technology, complex algorithms, and real-time image processing to blur the image's center of vision when it is displayed to the dominant eye.
This encourages the two eyes work together and promotes the brain to fill in the fine details of the amblyopic eye's vision. The system shares treatment reports with caregivers via a web site and is intended for usage at home.
The CureSight web platform enables ECPs to keep track of their patients' treatment compliance and progress Additionally, a nationwide Monitoring Center offers complete, end-to-end support for doctors and patients. The Monitoring Center's services, which are overseen by working ophthalmologists and backed by a group of trained ocular specialists and patient engagement experts, include compliance monitoring, troubleshooting, billing, and technical assistance.