FDA grants clearance for amblyopia treatment device

NovaSight’s CureSight is a digital device that proved in a pivotal study to be non-inferior to patching, according to the company.

Video transcript

Note: This transcript has been lightly edited for clarity.

Ran Yam, CEO, NovaSight: So today I'll update you from the Eyecelerator meeting here in Chicago about the progress at NovaSight.

The first thing and most important one is that we are very, very happy to announce that we just received the FDA clearance for our amblyopia lazy eye treatment device called CureSight. A few months ago, we released the top-line data coming from our pivotal study that was comparing CureSight to the gold standard patching. And we proved for the very first time in a pivotal study, that digital device is non-inferior to patching.

Not only that it was found on inferior, but actually, we proved that the treatment group was better than patching, with 80% of the treatment group approving two lines versus only 60% with the control patching group.

Having this very important milestone together with the three CPT codes, unique CPT codes that were approved for treatment, the beginning of the year, we are building the foundation towards a commercial launch of this device already this year.

In parallel, we established a monitoring center here in the U.S. that would take her take care of technical support, compliance monitoring, and billing that will take all the hassle away from the clinic.

So we are very, very excited to launch this important innovation this year. And on parallel, we are developing other important and interesting solutions, diagnostic solution, called EyeSwift Pro, an application for monitoring for controlling myopia, which is called Traxion. Thank you.