Oculocare's Alleye Receives FDA 510(k) Clearance for Monitoring Eyesight in AMD
Pubblicato il: 09/07/2018 15:02
Oculocare medical Inc., a Swiss technology company, announces today 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," 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."
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 US, Oculocare seeks to market Alleye through alliances with a pharmaceutical or medical technology partner.
Alleye is a technology containing two components. Patients perform measurements on an integrated App on smartphones or tablets while doctors assess the test results on a web application in their practice or clinic. Alleye is designed to detect and characterize central and paracentral metamorphopsia (visual distortions) in risk groups (persons from the age of 55) and in patients with macular conditions including age-related macular degeneration (AMD), diabetic macular edema (DME) and central retinal vein occlusion (CRVO). Alleye received a CE mark in Europe in 2017 and FDA 510(k) clearance in the US. Alleye® is a registered trademark of Oculocare medical Inc. For more information consult http://www.alleye.io.
About Oculocare medical Inc.
Oculocare medical is a Swiss start-up company founded in 2015 with the aim to develop innovative medical software applications for age-related macular degeneration (AMD) as well as for diabetic retinopathy. Oculocare is certified with ISO 13485:2012. For more information visit http://www.oculocare.com.
About age-related macular degeneration and diabetic retinopathy
AMD is the leading cause of blindness in developed countries and affecting about 1 in 10 individuals. Diabetic retinopathy is an eye disease developing in patients with diabetes when high blood sugar levels cause damage to the retina. Four out of five patients with diabetes for more than 20 years will develop diabetic retinopathy. Early detection and timely therapeutic intervention can significantly improve outcomes, prevention of blindness and preservation of eyesight.