8月11日宣布，欧盟委员会（EC）批准眼科药物Eylea（aflibercept，阿柏西普注射液）用于治疗糖尿病性黄斑水肿（DME）导致的视力损害。拜耳计划立即在欧盟推出该药。此前，Eylea于7月底获FDA批准，用于DME适应症。
目前，Eylea已获欧洲、美国、日本、澳大利亚及其他国家批准，用于治疗新生血管性年龄相关性黄斑变性（wet-AMD）的治疗。此外，Eylea于2013年8月获欧盟（EC）批准，用于治疗视网膜中央静脉阻塞(CRVO)继发黄斑水肿（ME）所致的视力损害，同时已获美国及亚洲、非洲特定国家批准用于治疗CRVO继发ME。
Eylea获批用于DME适应症，是基于III期VISTA-DME和VIVID-DME研究的积极数据，2项研究中，治疗52周时，与激光光凝（laser photocoagulation）相比，Eylea治疗组最佳矫正视力（BCVA）从基线的变化取得了统计学意义的显著改善。各研究中Eylea治疗组均表现出了相似的BCVA改善。
VIVID-DME和VISTA-DME试验设计相似，均为随机、双盲、活性对照试验，旨在评估Eylea治疗DME的安全性和有效性。这2个试验中，患者随机接受每月2mg Eylea、每2个月2mg Eylea（完成最初5个月每月2mg注射后）或激光光凝治疗（laser photocoagulation）。
VIVID-DME试验中，治疗1年后，每月2mg Eylea治疗组BCVA相对基线增加了10.5个字母（p<0.0001，与光凝组相比），每2个月2mg Eylea治疗组（完成最初5个月每月2mg注射后）BCVA相对基线增加了10.7个字母（p<0.0001，与光凝组相比），激光光凝组BCVA相对基线增加了1.2个字母。
VISTA-DME试验中，治疗1年后，每月2mg Eylea治疗组BCVA相对基线增加了12.5个字母（p<0.0001，与光凝组相比），每2个月2mg Eylea治疗组（完成最初5个月每月2mg注射后）BCVA相对基线增加了10.7个字母（p<0.0001，与光凝组相比），激光光凝组BCVA相对基线增加了0.2个字母。
关于Eylea：
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 EU Approval for EYLEA® in Diabetic Macular Edema
Berlin, August 11, 2014 – Bayer HealthCare announced today that EYLEA® (aflibercept solution for injection into the eye) has been approved by the European Commission for the treatment of visual impairment due to diabetic macular edema (DME). Bayer plans for an immediate roll-out with Germany being one of the first launch countries in Europe.
“The approval of EYLEA in Europe in this important indication is great news for the increasing number of patients suffering from visual impairment due to DME,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “This is an important step that further demonstrates our commitment in ophthalmology to bring new treatment options to patients suffering from serious ophthalmologic conditions.”
“The results of two phase 3 studies were very encouraging with the majority of patients with visual impairment due to diabetic macular edema experiencing a significant two-line improvement in visual acuity with aflibercept solution for injection,” said Prof. Jean-Francois Korobelnik, Principal Investigator of the VIVID-DME trial and Chief of Ophthalmology, CHU Bordeaux. “Early diagnosis of DME is critical, and if not treated rigorously, there is a high risk of DME leading to blindness.”
EYLEA has been approved in many countries for the treatment of neovascular age-related macular degeneration (wet AMD) and for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Regulatory submissions have been made in Asia Pacific including Japan and Latin America for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). Furthermore a regulatory submission has been made in Europe and the U.S. for EYLEA for the treatment of visual impairment due to macular edema following branch retinal vein occlusion.
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 has 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 percentage of net sales.
About Diabetic Macular Edema (DME)
Diabetic macular edema (DME) and diabetic retinopathy (DR) are common microvascular complications in people with diabetes. Diabetic retinopathy is a disease affecting the blood vessels of the retina. DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness.
Visual impairment due to DME is estimated to affect 3-4% of people with diabetes and is therefore the most frequent cause of blindness in young and mid-aged adults in most developed countries. As the incidence of diabetes has been steadily climbing, it is projected that the number of people impacted by DME will also grow.
About VEGF and EYLEA® (aflibercept solution for injection into the eye)
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.
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. 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 receptors.