Business Wire

Eyenuk’s AI Eye Screening System For Diabetic Retinopathy Demonstrates Exceptional Performance In A Prospective, Multi-Center, Pivotal Clinical Trial

Share

Eyenuk, Inc., a global artificial intelligence (AI) medical technology and services company and the leader in real-world applications for AI Eye Screening™, announced today results from its landmark prospective, multi-center, pivotal clinical trial to validate the EyeArt® AI Eye Screening System for autonomous detection of diabetic retinopathy (DR), a blinding disease estimated to affect 191 million people globally by the year 20301. The results were presented at the ARVO Imaging in the Eye Conference by Jennifer Lim, MD, Marion H. Schenk Esq. Chair and Professor of Ophthalmology and Director of Retina Service at the University of Illinois at Chicago.

The EyeArt AI Eye Screening System makes in-clinic, real-time DR screening possible for any physician, enabling quick and accurate identification of patients with referable DR during diabetic patient’s regular physician visit. Once the patient’s fundus images have been captured and submitted to the EyeArt System, the DR screening results are available to view and export to a PDF report in less than 60 seconds. The EyeArt system can free eye care specialists to focus on sight-saving treatment rather than screening for DR.

Key aspects of this prospective, multi-center, pivotal clinical trial (NCT03112005) include:

  • 942 subjects enrolled at 15 centers that included primary care, endocrinology, ophthalmology, and retina specialty clinics.
  • EyeArt AI system’s assessment of 2-field undilated images was compared to comprehensive clinical reference standard comprising adjudicated grading of 4 wide-field dilated stereo images on the ETDRS severity scale2. The grading was performed by the Wisconsin Fundus Photograph Reading Center.
  • Multiple fundus camera models were included and evaluated with the EyeArt AI eye screening system.
  • Board-certified ophthalmologists (in a subset of sites) independently performed dilated ophthalmoscopy, the most-prevalent method for DR screening today.

Study results show that all pre-determined primary endpoints were met with p<0.0001. Topline results from the pivotal study are in the table below (details here):

        Sensitivity

[95% Confidence Bounds]

      Specificity

[95% Confidence Bounds]

      Imageability

[95% Confidence Bounds]

   
EyeArt system

with no dilation

      95.5%

[92.4% - 98.5%]

      86.0%

[83.7% - 88.4%]

      87.5%

[85.4% - 89.7%]

EyeArt system

with dilation-if-ungradable

      95.5%

[92.6% - 98.4%]

      86.5%

[84.3% - 88.7%]

      97.4%

[96.4% - 98.5%]

                 

“This study is significant as it shows this AI system is quite accurate in determining the presence of referable diabetic retinopathy by a very rigorous method which compared the AI results to that of photos read by expert graders of diabetic retinopathy,” said Dr. Jennifer Lim, an Investigator in the EyeArt pivotal trial. “In this prospective multi-center study, we showed feasibility and applicability of this system for screening for referable diabetic retinopathy. This holds great promise in accomplishing screening of the millions of diabetic patients for referable diabetic retinopathy in order to identify those at risk of visual loss and refer them for prompt treatment by ophthalmologists!” Dr. Lim continued, “The high sensitivity and specificity achieved by the EyeArt system shows that it can enable point-of-care DR screening and that it is a safe way to identify patients with DR who require ophthalmology referrals.”

“Completion of this EyeArt prospective pivotal trial is an exciting step for Eyenuk, and this study once again validates the EyeArt System’s exceptional diagnostic sensitivity and specificity without needing dilation,” said Kaushal Solanki, PhD, Founder and CEO of Eyenuk. “Today I am proud to say that artificial intelligence is living up to its promise and can deliver substantial and meaningful impact to patients’ lives globally. Regular and quality eye screening can soon be accessible and affordable to hundreds of millions of people living with diabetes, leading to vision preservation for many of them.”

Eyenuk will showcase its EyeArt AI Eye Screening System at Booth #1637 in the ARVO Exhibition Hall at the Vancouver Convention Centre.

About the EyeArt® AI Eye Screening System

The EyeArt AI Eye Screening System is the most extensively validated AI technology for autonomous detection of DR, tested in the real-world on more than half million patient visits globally with over two million images collected in real-world clinical environments. The EyeArt System was developed with funding from the US National Institutes of Health (NIH) and is validated by the UK National Health Service (NHS). The EyeArt System has CE marking in the EU and a Health Canada license. In the US, the EyeArt System is limited by federal law to investigational use.

VIDEO: Learn more about the EyeArt AI Eye Screening System for Diabetic Retinopathy

About Diabetic Retinopathy (DR)

DR is a complication of diabetes caused by damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina). It is a silently progressing disease that at first may cause no symptoms or only mild vision problems. Eventually, it can cause blindness. The condition can develop in anyone who has type 1 or type 2 diabetes.3 It is estimated that one-third of all patients with diabetes will develop DR,4 making it the leading cause of vision loss in working-age adults.5

While DR screening is recommended for all diabetic patients, less than half get screened annually1, even in the developed world. Since diabetic patients outnumber ophthalmologists by 1,600 to 1 in the U.S.,6 there are just not enough eye care specialists to meet the DR screening needs of the growing diabetic population. Even for those receiving their annual screening, ophthalmology appointment wait times for DR screening can be weeks or even months.

About Eyenuk, Inc.

Eyenuk, Inc. is a global artificial intelligence (AI) medical technology and services company and the leader in real-world AI Eye Screening™ for autonomous disease detection and AI Predictive Biomarkers™ for risk assessment and disease surveillance. Eyenuk is on a mission to screen every eye in the world to ensure timely diagnosis of life- and vision-threatening diseases, including diabetic retinopathy, glaucoma, age-related macular degeneration, stroke risk, cardiovascular risk and Alzheimer’s disease.

EyeArt is a registered trademark of Eyenuk, Inc.

http://bit.ly/2vqwHNf

1 International Diabetes Federation. IDF Diabetes atlas, Sixth edition, Brussels, Belgium. 2015.
2 Early Treatment Diabetic Retinopathy Study Research Group Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. 1991, Ophthalmology 98(5 Suppl):823–833.
3 https://www.mayoclinic.org/diseases-conditions/diabetic-retinopathy/symptoms-causes/syc-20371611
4 Yau JW, Rogers SL, Kawasaki R, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care . 2012;35:556-64. doi: 10.2337/dc11-1909
5 Prokofyeva E, Zrenner E. Epidemiology of major eye diseases leading to blindness in Europe: a literature reviewOphthalmic Research. 2012;47:171-188. doi: 10.1159/000329603
6 http://www.icoph.org/ophthalmologists-worldwide.html and https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

Contact information

Media Contact:
Ida Yenney
Capwell Communications
ida@capwellcomm.com
949-999-3303

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Defence Unlimited International Corp. is Hiring Veterans17.7.2019 20:58:00 CESTPress release

Defence Unlimited International is one of the fastest growing companies operating within the defence and security space. Defence Unlimited International has adopted a unique outsourced model which integrates multiple partners both individual and corporate, on its projects. This has enabled it to offer and deliver to its clients best of breed bespoke solutions. Whilst Defence Unlimited is pursuing its drive towards achieving a more global footprint in its operations, the founder, Edward Banayoti firmly reiterates the continued commitment of the company to its existing strategy of identifying and successfully deploying experienced individuals that have served in the military. Individuals and teams with such experience can offer invaluable value added within projects Defence Unlimited are active in or are in the process of executing. "We take pride in our track record of offering numerous opportunities to Veterans who have served their country, giving such individuals who have heeded a pa

Gartner Names Airship a Leader, Positioned Highest in Execution and Furthest in Vision in the Magic Quadrant for Mobile Marketing Platforms17.7.2019 15:59:00 CESTPress release

Customer engagement company Airship today announced that it has been named a Leader by Gartner, Inc. in its 2019 Magic Quadrant for Mobile Marketing Platforms1. Among 18 vendors evaluated, Airship was positioned highest in its ability to execute and also furthest for its completeness of vision. A complimentary copy of the full report is available from Airship. “We believe Gartner’s positioning of Airship validates our unique ability to deliver innovative, transformative digital customer experiences for the world’s leading brands,” said Brett Caine, CEO and president, Airship. “Airship delivers rich messages with pinpoint accuracy on whatever channel is most convenient and effective for the customer. Today’s customer expects proactive information and real-time response, and Airship is the essential component that makes it all possible.” According to Gartner, “Globally, consumers spend more of their time on smartphones than on desktops, laptops or tablets. This broad and rapid consumer a

GSMA Signs £38 Million Funding Partnership With the Department of International Development17.7.2019 15:02:00 CESTPress release

The GSMA today announced that it has signed a thirty-eight million-pound partnership with the UK’s Department for International Development (DFID). The ‘Partnership for Inclusion, Innovation and Scale’ will provide funding for the GSMA’s Mobile for Development work on digital inclusion, digital identity, energy, water, sanitation and the reduction of the mobile gender gap. It will also include two new areas of focus: disability and climate. “This landmark partnership with DFID reinforces the joint power and potential of the private and public sectors working together and ensures that we will continue our crucial role of stimulating digital innovation to deliver both sustainable business and large-scale socio-economic impact for the underserved,” said Mats Granryd, Director General, GSMA. “This project reinforces our commitment to supporting the UN’s Sustainable Development Goals and using the power of technology to reduce global inequalities.” Inclusion, Innovation and Scale The partne

Gilead Sciences Announces Changes to Senior Leadership Team17.7.2019 12:30:00 CESTPress release

Gilead Sciences, Inc. (Nasdaq: GILD) announced today changes to the company’s senior leadership team. Gregg Alton, Chief Patient Officer, and Katie Watson, Executive Vice President, Human Resources, will be departing Gilead. Jyoti Mehra has been named Executive Vice President, Human Resources, and will assume responsibility for the worldwide HR function. Mr. Alton joined Gilead in 1999 and most recently has led Gilead’s corporate and medical affairs functions and developing world access programs, as well as commercial operations in certain countries of Asia and Latin America. He previously served as general counsel and helped to architect the company’s innovative access model for HIV and viral hepatitis medicines in resource-limited countries. He will remain with Gilead through October 4 and plans to serve in an advisory capacity until the end of the year to help transition his responsibilities to other parts of the organization. “Gregg has been a valued leader at Gilead for nearly 20

Gilead Sciences’ Chief Scientific Officer John McHutchison to Leave the Company17.7.2019 12:30:00 CESTPress release

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that John McHutchison, AO, MD, Chief Scientific Officer and Head of Research & Development, has decided to leave the company, effective next month. The company will immediately commence a search for his successor. Dr. McHutchison joined Gilead in 2010 and under his leadership, Gilead has developed five medicines that have been used by more than 3.2 million people around the world for the curative treatment of chronic hepatitis C, and treatment of chronic hepatitis B. He also oversaw the company’s expansion into oncology with the development of Gilead’s first cancer medicine, Zydelig® (idelalisib). He was appointed Chief Scientific Officer in March 2018. During his tenure, he has been responsible for broadening and overseeing the company’s Research and Development pipeline, advancing candidates in new therapeutic areas, including oncology, cell therapy and inflammation. “Over the past nine years, John’s scientific contributions and le