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March 11, 2022

NovaSight reports positive data from amblyopia treatment device

CureSight showed improvement in Best Corrected Visual Acuity at week 16 of the pivotal trial.

NovaSight has reported positive data from a pivotal trial of its eye-tracking based digital treatment device, CureSight, for the treatment of amblyopia, which is commonly known as ‘lazy eye’.

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The digital device is designed to train the visual system to use both eyes equally while watching any streamed video through red-blue treatment glasses.

CureSight uses algorithms and eye-tracking technology to blur the image’s centre of vision shown to the strong eye through real-time image processing, encouraging the amblyopic eye to work with the stronger eye as a team.

It can be used at home and shares treatment reports with caregivers through a Cloud portal.

The randomised, multicentre, controlled pivotal clinical trial was conducted on 103 subjects aged four to nine years in six medical centres, including Sheba Medical Center in Tel Aviv, Israel.

In the trial, participants were randomised and the improvement in visual outcomes achieved through treatment with CureSight digital was compared with eye patching, the existing gold-standard-of-care treatment for amblyopia.

The study’s top-line analyses showed that the improvement of Best Corrected Visual Acuity (BCVA) at week 16 was high in the CureSight digital treatment group versus the eye patching group.

NovaSight stated that the pivotal trial also assessed adherence and patient satisfaction.

NovaSight CEO Ran Yam said: “Eye patching is effective when patients are compliant, however, patching is often associated with insufficient adherence due to the discomfort it brings to the patient and the social stigma that many children experience when wearing a patch.”

The company said that the completion of the CureSight pivotal trial represents a significant step towards securing approval from the US Food and Drug Administration (FDA), following the device’s receipt of CE mark.

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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