Press release

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

Sponsored by Businesswire

, 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)

  • 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


[95% Confidence Bounds]


[95% Confidence Bounds]


[95% Confidence Bounds]

EyeArt system

with no dilation


[92.4% – 98.5%]


[83.7% – 88.4%]


[85.4% – 89.7%]

EyeArt system

with dilation-if-ungradable


[92.6% – 98.4%]


[84.3% – 88.7%]


[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

Learn more about the EyeArt AI Eye Screening System for Diabetic

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.

1 International Diabetes Federation. IDF
Diabetes atlas
, Sixth edition
, Brussels, Belgium. 2015.
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.
Yau JW, Rogers SL, Kawasaki R, et al. Global
prevalence and major risk factors of diabetic retinopathy. Diabetes
. 2012;35:556-64. doi: 10.2337/dc11-1909
Prokofyeva E, Zrenner E. Epidemiology
of major eye diseases leading to blindness in Europe: a literature review
. 2012;47:171-188. doi: 10.1159/000329603