Oculocare Medical announced the FDA 510(k) clearance of Alleye, a mobile medical software application indicated for the detection and monitoring of age-related macular degeneration (AMD).
Alleye 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/or assess disease progression.
“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,” Lucas Bachmann, CEO and co-founder of Oculocare, said in a company news release. “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.”
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.
Oculocare is commercializing Alleye in Europe independently since 2017 and through partnerships with Novartis and Bayer. In the United States, Oculocare seeks to market Alleye through alliances with a pharmaceutical or medical technology partner.