BAYER REPORTS POSITIVE VEGF TRAP-EYE PHASE-III RESULTS (ENG)

     (The following press release from Bayer was received by e-mail. It was not 
confirmed by the sender.) 
News-Release 
Not intended for U.S. and UK Media - VEGF Trap-Eye in myopic choroidal
neovascularization:
Positive Phase 3 Results for VEGF Trap-Eye (Intravitreal Aflibercept) in
Myopic Choroidal Neovascularization (mCNV) 
Berlin, June 6, 2013 - Bayer HealthCare announced today positive top-line
results for VEGF Trap-Eye (aflibercept ophthalmic solution) from the Phase
3 MYRROR study in myopic choroidal neovascularization (mCNV). In this
trial, patients receiving VEGF Trap-Eye at a dose of 2 milligrams (mg) had
a mean improvement in best-corrected visual acuity (BCVA) from baseline at
week 24 of 12.1 letters, compared to a loss of 2 letters in patients
receiving sham injections ( p<0.0001). VEGF Trap-Eye treatment was started
with a single injection; additional injections were given only in case of
newly occurring or persisting mCNV. 
"Effective treatment options are urgently needed for patients with myopic
choroidal neovascularization (mCNV)," said Kemal Malik, MD, member of the
Bayer HealthCare Executive Committee and Head of Global Development. "We
are pleased that the results of this study demonstrate that VEGF Trap-Eye
provides a treatment option for these patients." 
Data from this study will be presented at an upcoming medical conference.
Bayer HealthCare expects to submit the first application for regulatory
approval for this indication in Asia in the second half of 2013. 
VEGF Trap-Eye was generally well tolerated. The most common adverse events
observed in the MYRROR trial that occurred with a frequency of 2% or more
were conjunctival hemorrhage, dry eye, eye pain, headache and
nasopharyngitis. 
VEGF Trap-Eye was approved under the brand name EYLEA® in the United States
for the treatment of neovascular (wet) Age-related Macular Degeneration
(AMD) in November 2011 and for Macular Edema following Central Retinal Vein
Occlusion (CRVO) in September 2012. Outside of the U.S. EYLEA has been
approved for use in wet AMD in Japan, Australia, Europe, and several other
countries. 
Bayer HealthCare and Regeneron 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 will share equally the profits from
any future sales of EYLEA, except for Japan where Regeneron will receive a
royalty on net sales. 
About Phase 3 MYRROR Program
MYRROR was a double-masked, sham-controlled trial that randomized 122
patients to receive either VEGF Trap-Eye 2 mg or sham. Patients in the
active treatment arm received one initial 2 mg dose of VEGF Trap-Eye.
Patients were evaluated every 4 weeks and were eligible to receive
additional VEGF Trap-Eye 2 mg intravitreal injections on an as-needed (PRN)
basis, determined by visual and anatomic criteria, through 20 weeks.
Patients on the sham arm received monthly sham injections through week 20.
Starting at week 24, patients in both arms were eligible to receive VEGF
Trap-Eye 2 mg on a PRN basis through week 44. 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, a standard chart used in research to measure visual
acuity. 
About mCNV
"Myopic choroidal neovascularization" is an acute 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 (wet AMD), which is also characterised
by an acute growth of new, abnormal blood vessels in the retina. 
Severe myopia is particularly common in Asia. 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 patients. In East Asia,
the prevalence of myopia is significantly higher than in West Asia, and
appears to have an earlier onset. In Japan, pathologic myopia is the second
most common cause of blindness. 
About VEGF Trap-Eye (aflibercept solution for injection)
VEGF Trap-Eye 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. VEGF Trap-Eye acts as a soluble decoy receptor that binds
VEGF-A and placental growth factor (PlGF) and thereby can inhibit the
binding and activation of these cognate VEGF receptors. VEGF Trap-Eye is
specially purified form of aflibercept and contains iso-osmotic buffer
concentrations, allowing for injection into the eye. 
About Regeneron Pharmaceuticals
Regeneron is a leading science-based biopharmaceutical company based in
Tarrytown, New York that discovers, invents, develops, manufactures, and
commercializes medicines for the treatment of serious medical conditions.
Regeneron markets medicines for eye diseases, colorectal cancer, and a rare
inflammatory condition and has product candidates in development in other
areas of high unmet medical need, including hypercholesterolemia, oncology,
rheumatoid arthritis, allergic asthma, and atopic dermatitis. For
additional information about the company, please visit
http://www.regeneron.com. 
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 EUR 18.6 billion (2012), 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 55,300 employees (Dec
31, 2012) and is represented in more than 100 countries. More information
at http://www.healthcare.bayer.com. 
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Forward-Looking Statements
This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management.
Various known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results, financial
situation, development or performance of the company and the estimates
given here. These factors include those discussed in Bayer’s public reports
which are available on the Bayer website at http://www.bayer.com. The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments. 
Contact:
Pharmaceuticals
Doreen Schröder, Tel. +49 30 468-11399
E-Mail: mailto:doreen.schroeder@bayer.com 
This press release is available here:
http://www.baynews.bayer.de/baynews/baynews.nsf/id/2013-0317-e 
Yours BayNews Editorial Team 
Bayer AG
Communications
Building W11
51368 Leverkusen, Germany 
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