FDA clears AMD monitoring app

Alleye, a mobile medical application developed to monitor progression of patients with AMD, was approved by the FDA earlier this week.

Designed by Oculocare, the app is a self-exam that patients can perform on their personal mobile devices. It detects central and paracentral metamorphopsia by testing a patient’s ability to see straight lines.

"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. 

The Swiss company claims their app is 10 times more precise than visual acuity tests and can detect waning vision before a patient sees it. Alleye was evaluated in 5 scientific studies that tallied more than 25,000 measurements.

While the app itself is free of charge, patients are required to purchase a 1-year license to connect their mobile device to their healthcare professional. Physicians, meanwhile, can securely access test results via any web browser.

Oculocare has been marketing Alleye in Europe since 2017, both independently and through partnerships with Novartis and Bayer. They are seeking a pharmaceutical or medical technology partner to help market the app in the United States.