Eyenuk Announces CE Mark and Commercial Launch of EyeArt 2.0

Eyenuk Inc., developer of advanced retinal image analysis solutions to identify eye disease, has received CE Mark approval and launched the second generation of its EyeArt fully automated diabetic retinopathy (DR) screening software. The company plans to roll out EyeArt 2.0 to selected, leading eye care centers in Europe over the next few months.
 
The commercial launch is supported by a new study of the EyeArt 2.0 technology, which demonstrated 98.3 percent sensitivity in identifying potentially treatable patients with severe non-proliferative or proliferative DR, and/or the presence of surrogate markers for CSME. In the study, the overall screening sensitivity for detecting referable DR patients was 91 percent (95 percent CI: 90.5 percent – 91.6 percent) with specificity of 90.8 percent (95 percent CI: 0.957-0.961).

Watch the video below for a brief introduction to EyeArt technology:

 

The study encompassed 469,953 real world, color retinal fundus images from 59,005 consecutive diabetic patient visits captured by EyePACS, a large, well-established telemedicine program for diabetic retinopathy screening.
 
“While a few commercial or academic automated screening approaches have achieved over 90 percent sensitivity, it has come at the significant expense of specificity,” said Eyenuk CEO Kaushal Solanki. “For the first time, we have a system that has clinically demonstrated over 90 percent in both sensitivity and specificity. With this milestone, we believe that EyeArt 2.0 is the most advanced DR screening technology currently available.”
 
“As diabetic eye complications are silent in their developing stages, screening and early detection of treatable lesions are essential, and have been shown in the UK to be effective in reducing visual loss,” said diabetes expert professor Andrew Boulton, M.D., DSc (Hon), FACP, FRCP, professor of medicine at the University of Manchester in the United Kingdom. “EyeArt has the potential to have a huge impact in improving lives of individuals with diabetes by helping us clinicians accurately identify at-risk patients, provide timely treatment, and prevent vision loss.”
 
EyeArt 2.0 provides fully automated DR screening in one short office visit, including imaging, grading, and reporting for DR in accordance with internationally recognized standards, such as the UK’s NHS Diabetic Eye Screening Programme (NDESP) and the International Clinical Diabetic Retinopathy Disease Severity Scale (ICDR). It has been tested on one of the largest data sets of patient cases of any available DR screening technology, in demanding, real world settings using images captured in everyday practice. The technology is designed to be flexible, working effectively with a variety of imaging protocols used in screening setups.
 
In an independent, comparative study of 20,258 consecutive patients using predecessor software (EyeArt 1.0) that was presented in May at ARVO, the EyeArt technology rated highest among evaluated DR screening technologies in sensitivity across all types of DR. The study was funded by the UK National Institute for Health Research HTA program and the Department of Health’s NIHR Biomedical Research Centre for Ophthalmology at Moorfields Eye Hospital.
 
Diabetic retinopathy is a blinding eye disease which can affect many of the 415 million diabetic patients worldwide. Vision loss due to DR is preventable, if diagnosed early. However, the current number of eye care professionals cannot keep pace with the demand for annual screening, making DR the leading cause of blindness in working-age adults in the industrialized world. Experts have recognized that the only feasible way to address this issue is to efficiently expand DR screening in the primary care environment via computerized analysis.

Eyenuk Inc., headquartered in Los Angeles, Calif., helps identify patients suffering from potentially blinding eye diseases and works to preserve their vision. Using computer vision and image analysis expertise, the company is developing a portfolio of products based on its proprietary retinal image analysis technology to identify and track the progression of eye diseases, including diabetic retinopathy and age-related macular degeneration (AMD).

EyeArt is a trademark of Eyenuk, Inc.
 
EyeArt has received the CE Mark and is commercially available in the European Union. In the United States, EyeArt is limited by federal law to investigational use only and is not available for sale.