FDA certifies Oculocare’s Alleye for monitoring eyesight

11.07.2018 11:30
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Zurich based Oculocare Medical has received the FDA 510(k) clearance of Alleye, a mobile medical software application. The solution is designed for detecting and monitoring of age-related macular degeneration (AMD). The startup now plans for market entry into the U.S.

Established in 2015, the Zurich based Oculocare medical is focusing on the development of innovative medical software applications for age-related macular degeneration (AMD) – leading cause of blindness in developed countries and affecting about 1 in 10 individuals – as well as for diabetic retinopathy.

The company’s flagship product is Alleye, which is designed to detect and characterize central and paracentral metamorphopsia (visual distortion) in patients with macular conditions including AMD and diabetic retinopathy. After medical diagnosis by an eye specialist, the mobile application Alleye lets patients regularly perform simple self-tests at home to monitor their eyesight and assess disease progression.

Alleye was developed by eye specialists to allow patients to regularly, and independently test their eyesight. The Alleye framework has been studied in five scientific studies in which several hundred subjects made over 25,000 measurements. Clinical findings have been presented at renowned medical conventions and scientific journals.

The startup has how received 510(k) certification by the US Food and Drug authority (FDA), thereby giving it a green pass for commercializing its product to save affected patients. According to the FDA, "a 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA)".

"We are very excited about the FDA clearance which will help millions of patients with AMD to better manage their health by monitoring their eyesight," said Lucas Bachmann, CEO and Co-founder of Oculocare. "We are committed to advancing medical software innovations that leverage digital technology to improve patient care. After Europe, we plan to make Alleye available in the US and other countries worldwide thereby enhancing patient health and fully exploiting the potential of our medical-mobile platform."

Oculocare is commercializing Alleye in Europe independently since 2017 and through partnerships with Novartis and Bayer. In the US, Oculocare seeks to market Alleye through alliances with a pharmaceutical or medical technology partner.

(Press release/ran)

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