September 18, 2015
Three-Year Results with EYLEA Show Sustained Improvement in Vision for People with Diabetic Macular Edema
results for the Phase 3 VIVID-DME trial of EYLEA® (aflibercept solution for
injection) for the treatment of visual impairment due to diabetic macular edema
(DME). The results, presented today at the 15th EURETINA Congress (17-20
September, 2015) in Nice, France, showed sustained improvements in best
corrected visual acuity (BCVA) at three years, for EYLEA 2 milligrams (mg),
compared to laser photocoagulation.
"Allowing people whose eye sight has been impaired as a result of their
diabetes the opportunity to regain and retain their vision over time is
critical," said Prof. Jean-Francois Korobelnik, Principal Investigator of the
VIVID-DME trial and Chief of Ophthalmology, CHU Bordeaux, who presented the
data at the EURETINA Congress today. "Therefore these results are encouraging
as the data show patients who achieved vision gains in the first year,
maintained these gains over three years."
The VIVID-DME trial is now complete. Patients in this study were randomized to
receive either EYLEA 2 mg every month (n=136), EYLEA 2 mg every two months
(after an initial injection every month for five consecutive doses) (n=135), or
the comparator treatment of laser photocoagulation (n=132). After two years,
patients randomized to laser could receive EYLEA 2 mg according to protocol
specific re-treatment criteria (PRN). After three years, patients receiving
EYLEA every month had a mean gain in BCVA from baseline of 10.3 letters,
patients receiving EYLEA every two months had a mean gain in BCVA from baseline
of 11.7 letters. Patients in the laser photocoagulation treatment group had a
mean change in BCVA from baseline of 1.6 letters. Additionally after three
years, 41.2% of patients in the monthly group and 42.2% of patients receiving
EYLEA 2 mg every two months maintained significant gains of at least 15
letters, or three lines, as measured on the Early Treatment Diabetic
Retinopathy Scale (ETDRS) eye chart, a standardized tool used in research to
measure visual acuity, compared to 18.9% in the laser treatment group.
In this trial, patients treated with EYLEA show a similar overall incidence of
adverse events (AEs) as compared to the laser treatment group. The safety
results are in line with the 1 and 2 year data of the VIVID-DME and VISTA-DME
trials as well as the known safety profile of EYLEA. AEs were typical of those
seen in other studies in patients with diabetes receiving intravitreal
anti-VEGF therapy. The most frequent ocular AEs observed in the EYLEA groups
included conjunctival hemorrhage, cataract and increased intraocular pressure.
The most frequent non-ocular AEs in these groups included nasopharyngitis and
hypertension. Arterial thromboembolic events as defined by the Anti-Platelet
Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction,
and vascular death) occurred in 14 out of 136 patients (10.3%) receiving EYLEA
every month, 6 out of 135 patients (4.4%) in the EYLEA every two months group
and 7 out of 133 patients (5.3%) in the laser group.
EYLEA® is approved for the treatment of patients with neovascular age-related
macular degeneration (wet AMD), visual impairment due to diabetic macular edema
(DME) and macular edema secondary to central retinal vein occlusion (CRVO). In
Europe, Japan and the U.S., EYLEA is approved for the treatment of visual
impairment secondary to macular edema due to RVO (branch RVO or central RVO).
In Japan EYLEA is additionally approved for the treatment of visual impairment
due to myopic choroidal neovascularization. Over five million doses of EYLEA
have been administered since launch worldwide.
Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the
global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in
the United States. Bayer HealthCare licensed the exclusive marketing rights
outside the United States, where the companies share the profits equally from
sales of EYLEA, except for Japan where Regeneron receives a percentage of net
About Diabetic Macular Edema
Diabetic macular edema (DME) and diabetic retinopathy (DR) are common
microvascular complications in people with diabetes. DR is a disease affecting
the blood vessels of the retina. DME occurs when fluid leaks into the center of
the macula, the light-sensitive part of the retina responsible for sharp,
direct vision. Fluid in the macula can cause severe vision loss or blindness.
DME is the most frequent cause of blindness in young and mid-aged adults.
Approximately 3% of people living with diabetes have visual impairment due to
DME. As the incidence of diabetes has been steadily climbing, it is projected
that the number of people impacted by DME will also grow.
About VEGF and EYLEA® (Aflibercept solution for injection)
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in
the body. Its normal role in a healthy organism is to trigger formation of new
blood vessels (angiogenesis) supporting the growth of the body's tissues and
organs. It is also associated with the growth of abnormal new blood vessels in
the eye, which exhibit abnormal increased permeability that leads to edema.
EYLEA® is a recombinant fusion protein, consisting of portions of human VEGF
receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1
and formulated as an iso-osmotic solution for intravitreal administration.
Aflibercept acts as a soluble decoy receptor that binds VEGF-A and Placental
Growth Factor (PlGF) and thereby can inhibit the binding and activation of
their cognate VEGF receptors.
About Bayer HealthCare
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health care and agriculture. Bayer HealthCare, a subgroup of Bayer AG with
annual sales of around EUR 20.0 billion (2014), is one of the world's leading,
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based in Leverkusen, Germany. The company combines the global activities of the
Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer
HealthCare's aim is to discover, develop, manufacture and market products that
will improve human and animal health worldwide. Bayer HealthCare has a global
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