March 11, 2015
Bayer Submits Aflibercept Solution for Intravitreal Injection for the Treatment of Myopic Choroidal Neovascularization in the EU
marketing authorization of aflibercept solution for intravitreal injection for
the treatment of myopic choroidal neovascularization (myopic CNV) to the
European Medicines Agency (EMA).
"Myopic CNV is a severe eye condition which can affect any age group and if
left untreated can progress to legal blindness in a majority of patients," said
Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head
of Global Development. "Treatment options that could not only prevent permanent
vision loss but could also improve visual acuity have great benefits for
patients with myopic choroidal neovascularization."
Pathologic myopia and the associated myopic CNV is a common cause of blindness
globally in people under the age of 40 associated with severe myopia (short
sightedness) and more prevalent in Asian countries than in European countries.
Myopic CNV is associated with high degrees of myopia and leads to progressive
vision loss. Myopic CNV has a poor prognosis and, if left untreated, can,
within approximately 10 years, progress to legal blindness in a majority of
The application is based on positive data from the Phase 3 MYRROR study in
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 2 letters
(p<0.0001), as measured on the Early Treatment Diabetic Retinopathy Scale
(ETDRS) eye chart, a standard chart used in research to measure visual acuity.
Aflibercept solution for intravitreal injection has been approved already under
the brand name EYLEA® in Japan for the treatment of myopic CNV in September
2014. In addition, EYLEA has been approved in more than 80 countries for the
treatment of patients with neovascular age-related macular degeneration (wet
AMD), in around 30 countries for the treatment of visual impairment due to
macular edema secondary to retinal vein occlusion (RVO) and over 40 countries
for the treatment of visual impairment due to macular edema secondary to
central retinal vein occlusion (CRVO). EYLEA is also approved for the treatment
of diabetic macular edema (DME) in more than 40 countries. Over three million
doses of EYLEA have been administered since launch worldwide. For the treatment
of macular edema secondary to branch retinal vein occlusion (BRVO), an
application for marketing authorization has been submitted in Japan.
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 equally the profits from
sales of EYLEA, except for Japan where Regeneron receives a royalty on net
About Phase 3 MYRROR Program
MYRROR was a multi-center, double-masked, sham-controlled trial that randomized
122 patients to receive either aflibercept solution 2 mg or sham. The trial was
designed to assess the safety and efficacy of aflibercept solution, with three
quarters of patients receiving an injection of aflibercept solution and one
quarter receiving a sham injection. The primary endpoint of the study was the
mean change at week 24 from baseline in best-corrected visual acuity (BCVA) as
measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart.
Patients in the active treatment arm received one initial 2 mg dose of
aflibercept solution. Patients were evaluated every 4 weeks and were eligible
to receive additional intravitreal injections if the myopic CNV persisted or
recurred through week 44. Patients on the sham arm received monthly sham
injections through week 20. Starting at week 24, they could receive a single
injection of aflibercept solution 2 mg and were eligible to receive additional
treatment in case of CNV persistence or recurrence through week 44.
In the MYRROR study, patients receiving aflibercept solution had a mean
improvement in best-corrected visual acuity (BCVA) at week 24 of 12.1 letters
from baseline, compared to a loss of 2 letters in patients receiving sham
The efficacy gains seen at week 24 were maintained and even extended further in
the EYLEA arm until week 48. Patients received in the first quarter of the
study, i.e. from baseline to week 12, a median of 2 injections. In each of the
following three quarters, the median of injections was 0.
About Myopic Choroidal Neovascularization (mCNV)
Myopic choroidal neovascularization is a disease of the retina where new,
abnormal blood vessels grow into the retina in persons who are severely myopic
(typically more than 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 incite the
development of choroidal neovascularization. Anti-VEGF treatment has been shown
to be effective in wet age related macular degeneration, which is also
characterized by an acute growth of new, abnormal blood vessels in the retina.
About VEGF and Aflibercept Solution for Intravitreal 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.
Aflibercept solution for intravitreal 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.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, agriculture and high-tech materials. 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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