October 30, 2015
Bayer Receives EU Approval for EYLEA® for the Treatment of Visual Impairment Secondary to Myopic Choroidal Neovascularization
Commission for the eye drug EYLEA® (aflibercept solution for injection into the
eye) in a fifth indication. EYLEA is now also approved for the treatment of
visual impairment due to myopic choroidal neovascularization (myopic CNV).
Myopic CNV is a disease of the retina associated with high degrees of myopia
(near-sightedness) and frequently affects people of working age. Bayer plans
for an immediate introduction to the market with Germany being one of the first
launch countries in Europe.
"The results of the Phase III study were very encouraging with the majority of
patients experiencing a significant two-line improvement in visual acuity on a
standard eye chart with aflibercept solution for injection", said Dr. Joerg
Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global
Development. "A treatment option that could not only prevent permanent vision
loss, but also improve visual acuity could have great benefits for patients
with myopic CNV."
EYLEA® is already approved for the treatment of patients with wet age-related
macular degeneration, for the treatment of visual impairment due to diabetic
macular edema, and for the treatment of visual impairment due to macular edema
secondary to retinal vein occlusion (branch RVO or central RVO). Over five
million doses of EYLEA have been administered worldwide since its launch. EYLEA
has already been approved for the treatment of visual impairment due to myopic
choroidal neovascularization in Japan.
About Myopic Choroidal Neovascularization
Myopic choroidal neovascularization (mCNV) is a disease of the retina in
persons who are severely myopic (typically at least minus six diopters) and
have pathological changes in the back of the eye. The disease is characterized
by an abnormally elongated eye with a physical stretching of the sclera,
choroid and retina, resulting in degenerative and progressive changes. These
degenerative changes can induce the development of choroidal
neovascularization. Anti-VEGF therapy has already been shown to be effective in
the treatment of wet age-related macular degeneration (wet AMD), which is also
characterized by an acute growth of new, abnormal blood vessels in the retina.
About VEGF and EYLEA® (aflibercept solution for injection into the eye)
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.
Aflibercept solution for injection 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.
Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating closely
on the global development of EYLEA. Regeneron has exclusive marketing rights
for EYLEA in the USA. Bayer HealthCare has licensed the exclusive marketing
rights outside the USA, where the companies share equally the profits from
sales of EYLEA, except for Japan where Regeneron receives a royalty on net
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
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,
innovative companies in the healthcare and medical products industry and is
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
workforce of 60,700 employees (Dec 31, 2014) and is represented in more than
100 countries. More information is available at www.healthcare.bayer.com.
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