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Regeneron And Bayer Report Positive Phase 3 Results For EYLEA® (aflibercept) Injection In Myopic Choroidal Neovascularization (mCNV)

TARRYTOWN, N.Y., June 06, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced positive top-line results for EYLEA ® (aflibercept) Injection from the Phase 3 MYRROR study in myopic choroidal neovascularization (mCNV).  In this trial, patients receiving EYLEA at an initial dose of 2 milligrams (mg), followed by treatment on an as-needed (PRN) basis, had a mean improvement in best-corrected visual acuity (BCVA) from baseline at week 24 of 12.1 letters, compared to a loss of 2.0 letters in patients receiving sham injections (p<0.0001).  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. 

"Effective treatment options are urgently needed for patients with myopic choroidal neovascularization (mCNV)," said Kemal Malik, M.D., member of the Bayer HealthCare Executive Committee and Head of Global Development.  "We are pleased that the results of this study demonstrate that EYLEA may provide 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.

EYLEA was approved 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 the Phase 3 MYRROR Trial MYRROR was a double-masked, sham-controlled trial that randomized 122 patients to receive either EYLEA 2 mg or sham.  Patients in the active treatment arm received one initial 2 mg dose of EYLEA.  Patients were evaluated every 4 weeks and were eligible to receive additional EYLEA 2 mg intravitreal injections on an as-needed (PRN) basis, determined by visual and anatomic criteria, through 20 weeks.  Patients in the sham arm received monthly sham injections through week 20.  Starting at week 24, patients in both arms were eligible to receive EYLEA 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 EYLEA ® (aflibercept) Injection 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.  However, in certain diseases, such as myopic CNV, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema.  Scarring and loss of fine-resolution central vision often results.

EYLEA, known in the scientific literature as 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.  EYLEA 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.  EYLEA contains iso-osmotic buffer concentrations, allowing for injection into the eye.

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