September 25, 2015
Bayer's Eye Drug Recommended for EU Approval in Fifth Indication
Human Use (CHMP) has recommended aflibercept solution for injection into the
eye for the treatment of visual impairment due to myopic choroidal
neovascularization (myopic CNV) for approval in the EU. Myopic CNV is a disease
of the retina associated with high degrees of myopia (near-sightedness) and
frequently affects people of working age. It is a common cause of blindness in
near-sighted subjects worldwide.
"If left untreated, myopic CNV has an extremely poor prognosis resulting in
blindness in the affected eye within a few years," 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 would have great benefits for patients
with myopic CNV."
The CHMP's positive recommendation is based on the results of the Phase 3
MYRROR study in patients with myopic CNV. Patients receiving aflibercept
solution for injection had a mean improvement in best-corrected visual acuity
(BCVA) from baseline at week 24 of 12.1 letters, while patients receiving sham
injections lost two letters (p<0.0001), as measured on the Early Treatment
Diabetic Retinopathy Scale (ETDRS) eye chart, a standard instrument used in
medical research to measure visual acuity. The efficacy gains seen at week 24
were maintained and even extended further in the aflibercept arm until week 48.
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.
Aflibercept solution for injection into the eye has been approved under the
brand name EYLEA® 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 myopic choroidal
neovascularization in Japan.
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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