Bayer Receives Approval for EYLEA® in Next Indication in Europe
Approval for the treatment of visual impairment due to Macular Edema secondary to Central Retinal Vein Occlusion (CRVO) marks second indication for EYLEA
Berlin, August 29, 2013 – Bayer HealthCare announced today that EYLEA® (aflibercept solution for injection) has been approved by the European Commission for the treatment of visual impairment due to Macular Edema secondary to Central Retinal Vein Occlusion (CRVO).
"The results of the two phase III studies were encouraging with the majority of patients with Macular Edema secondary to Central Retinal Vein Occlusion experiencing a significant improvement in visual acuity with EYLEA," said Frank G. Holz, M.D., Professor at the Department of Ophthalmology, University of Bonn, Germany and Lead Principal Investigator of the GALILEO trial.
"EYLEA is already helping patients suffering from wet Age-related Macular Degeneration. The approval of this additional indication for EYLEA is great news for patients in Europe, as Macular Edema secondary to CRVO is a debilitating disease affecting patients´ central vision," said Kemal Malik, M.D., member of the Bayer HealthCare Executive Committee and Head of Global Development. "The loss of vision from Macular Edema secondary to CRVO not only impacts patients but, also their families' lives."
EYLEA is already approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) and for Macular Edema following CRVO. EYLEA has also been approved in Europe, Japan, Australia, and several other countries for use in wet AMD and in selected countries in South America for Macular Edema following CRVO.
Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except in Japan where Regeneron receives a royalty on net sales.
About Central Retinal Vein Occlusion (CRVO)
Over 66,000 people in major European countries and more than 100,000 people in the United States are estimated to suffer from CRVO. CRVO is caused by obstruction of the central retinal vein that leads to an accumulation of deoxygenated blood and fluid in the retina. Macular edema secondary to CRVO causes retinal damage and loss of vision. Release of vascular endothelial growth factor (VEGF) contributes to increased vascular permeability in the eye and macular edema. It has been shown that anti-VEGF treatment may help decrease vascular permeability and edema in the retina in patients with CRVO.
About VEGF and EYLEA® (aflibercept solution for 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. Scarring and loss of fine-resolution central vision often results.
EYLEA® 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 these cognate VEGF receptors.
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 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 www.healthcare.bayer.com.
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