2013年8月29日讯 /生物谷BIOON/ --拜耳(Bayer)8月29日宣布，眼科药物Eylea(aflibercept，阿柏西普注射液)新适应症申请获欧盟委员会(EC)批准，用于治疗视网膜中央静脉阻塞(central retinal vein occlusion,CRVO)继发黄斑水肿(Macular Edema，ME)所致的视力损害。这是Eylea在欧洲获批的第二个适应症，此前，Eylea已获EC批准用于湿性年龄相关性黄斑变性(wet-AMD)的治疗。

　　在美国，Eylea于2011年11月获FDA批准，用于治疗新生血管性(湿性)年龄相关性黄斑变性(wet-AMD)的治疗，并于2012年9月获FDA批准用于视网膜中央静脉阻塞(CRVO)继发黄斑水肿(ME)的治疗。Eylea也已获日本、澳大利亚及其他国家批准用于治疗wet-AMD。

　　Eylea是一种新型玻璃体内注射用VEGF抑制剂，是一种重组融合蛋白，由人体血管内皮细胞生长因子(VEFG)受体1和2的胞外区与人体免疫球蛋白G1的可结晶片段融合而成。

　　Eylea作为VEGF家族各成员(包括VEGF-A)及胎盘生长因子(PIGF)的一种可溶性诱饵受体发挥作用，与这些因子具有极高的亲和力，从而抑制这些因子与同源VEGF受体的结合，因此Eylea可抑制异常的血管生成及渗漏。

　　目前，拜耳和Regeneron正在合作Eylea的全球开发。Regeneron保留Eylea在美国的独家权利，拜耳则授权获得该药在美国以外国家和地区的独家销售权，这2家公司将平分Eylea在未来销售的利润。(生物谷bioon.com)

　　英文原文：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.