NovaSight eyes FDA clearance with upcoming clinical trial

 

NovaSight, an Israeli digital eye treatment and assessment startup in the pediatric space, announced a clinical trial for its CureSight system, with the goal of achieving Food and Drug Administration 510(k) clearance.

CureSight presents a new treatment method for amblyopia, also known as lazy eye, that doesn’t require patching. The device trains the brain to use both eyes simultaneously while the user watches videos through 3D glasses. Using artificial intelligence eye-tracking technology, it blurs what the dominant eye sees in order to strengthen the amblyopic eye – teaching the brain to complete the image.

The device is intended to be used at home, and it shares treatment reports with caregivers and parents through a mobile app.

Because CureSight can be used to view any digital content, previous research demonstrated that users had a 95% adherence to treatment. Past studies also revealed significant improvements in visual acuity and stereoacuity that remained stable at the six-month follow-up, the company said.

The new study is seeking 90 children with amblyopia between 4 and 9 years old. It is taking place in six different medical centers across Israel, including Sheba Medical Center, where the previous research was conducted.

WHY THIS MATTERS

Amblyopia has a cumulative incidence between 3% and 6%, according to the American Academy of Ophthalmology. If left untreated, it can limit career options, lead to fewer social interactions, cause low self-esteem and induce visual disorientation.

Patching remains one of the most popular treatment methods of amblyopia, with up to 90% of ophthalmologists choosing it as their first option, according to the Pediatric Eye Disease Investigator Group. This method requires the stronger eye to be covered with a patch to encourage the weaker eye to work harder.

While this treatment method lasts only a few months, some children find it hard to wear the patch as much as they’re supposed to, because it can be difficult to play and learn while wearing it, and they might get teased by their peers, according to the Institute for Quality and Efficiency in Health Care.

THE LARGER TREND

The social stigma and at times low adherence to patching has led to a rise in digital amblyopia treatments.

NovaSight completed an $8 million Series A raise last July to help launch this study and to assist in the development of future eye care products for myopia.

Others in the space include AmblyoPlay, which released a gamified amblyopia digital therapeutic in 2019, and GoCheck, which raised $6 million that same year for its smartphone app that screens young children for amblyopia.

More recently, the pharma giant Novartis joined the space with its acquisition of Amblyotech. Together with the French video game publisher Ubisoft and McGill University, Novartis plans to develop the Amblyotech software as a medical device.

ON THE RECORD

 "We're delighted with the initiation of this important trial, key in demonstrating how effective our lazy eye treatment is while being fun and engaging for the patient,” Ran Yam, CEO of NovaSight said in a statement.

“Our CureSight treatment allows children to enjoy a wide variety of content like TV programs, movies, and social media from home while treating and improving their vision. This is another important step on our journey of bringing revolutionary treatment for lazy eye to children everywhere."