拜耳（Bayer）6月27日宣布，眼科药物Eylea（aflibercept，阿柏西普注射液）获得了欧洲药品管理局（EMA）人用医药产品委员会（CHMP）的积极意见。CHMP建议批准Eylea用于治疗糖尿病性黄斑水肿（DME）导致的视力损害。欧盟委员会（EC）预计将在未来几个月内做出最终审查决定。此外，拜耳于6月中旬向EMA提交了Eylea治疗视网膜分支静脉阻塞（BRVO）继发黄斑水肿（ME）的新适应症申请，这也代表了Eylea在欧盟的第4个新适应症申请。
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于今年8月获欧盟（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，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用于DME适应症的上市许可申请的提交，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。2项试验中，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。
英文原文：Bayer Receives positive CHMP Opinion for the Treatment of Visual Impairment due to Diabetic Macular Edema in EU
Berlin, June 27, 2014 - Bayer HealthCare today announced that aflibercept solution for injection into the eye has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to diabetic macular edema (DME). The recommended dose is 2 milligrams (mg) aflibercept solution for injection into the eye equivalent to 50 microlitres. Treatment with aflibercept solution for injection is initiated with one injection into the eye per month for five consecutive doses, followed by one injection every two months into the eye without any requirement for monitoring between injections. After the first 12 months of treatment, the treatment interval may be extended based on visual and anatomic outcomes. The final decision of the European Commission is expected in the coming months.
"Early diagnosis of DME is critical," said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. "If DME is not treated rigorously, there is a high risk of DME leading to blindness. about
half of the patients lose more than two lines of vision within two years of diagnosis without treatment, which can impact their ability to perform important daily activities such as working and driving."
about the Phase 3 DME Program
The Phase 3 DME program consists of three double-masked trials: VIVID-DME, VISTA-DME, and VIVID-EAST-DME, and one open label single arm safety trial in Japanese patients (VIVID-Japan). All three double masked studies have three treatment arms, wher patients are randomized to receive either aflibercept solution for injection 2 mg monthly, aflibercept solution for injection 2 mg every two months (after 5 initial monthly injections), or the comparator treatment of laser photocoagulation. The primary endpoint of these three studies is the mean change in best-corrected visual acuity from baseline, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standardized eye chart used in research to measure visual acuity, at Week 52. The VIVID-DME, VISTA-DME and VIVID-EAST-DME studies are ongoing.
The submission is based on data from the positive Phase 3 VIVID-DME and VISTA-DME studies which showed aflibercept solution for injection into the eye 2 mg every other month achieved rapid and sustained visual acuity gains compared to treatment with laser photocoagulation.
In the VIVID-DME study, after Week 52, patients receiving aflibercept solution for injection 2 mg every other month (after 5 initial monthly injections) had a mean gain from baseline in best corrected visual acuity (BCVA) of +10.7 letters (p<0.0001). This is equivalent to a gain of more than two lines on the ETDRS-eye chart. Patients receiving laser photocoagulation had a mean change from baseline in BCVA of +1.2 letters. Additionally, thirty-three percent (33.3 %) of patients receiving aflibercept solution for injection 2 mg every other month achieved an increase of ? 15 letters, a gain of three lines from baseline as one key secondary endpoint compared to the laser treatment group with only nine percent (9.1%) (p<0.0001) achieving a similar gain.
In the VISTA-DME study, after Week 52, patients receiving aflibercept solution for injection 2 mg every other month (after 5 initial monthly injections) had a mean gain from baseline in BCVA of +10.7 letters (p<0.0001), compared to patients receiving laser photocoagulation who had a mean change from baseline in BCVA of +0.2 letters. Additionally, as reflected by one of the secondary endpoints, thirty-one percent (31.1 %) of patients receiving aflibercept solution for injection 2 mg every other month achieved an increase of ? 15 letters from baseline compared to the laser treatment group with close to eight percent (7.8%) (p<0.0001) achieving a similar gain.
Further secondary endpoints in the VIVD-DME and VISTA-DME studies included the change from baseline in central retinal thickness, diabetic retinopathy severity score and vision related quality of life.
In both studies, aflibercept solution for injection was generally well tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the treatment groups and the laser control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across treatment groups and the laser control group. The most frequent ocular treatment emergent AEs (TEAEs) observed in the VIVID-DME and VISTA-DME studies included conjunctival hemorrhage, eye pain, and vitreous floaters. The most frequent non-ocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the laser control group.
The second year data from the VISTA-DME study show the improvement in visual acuity was maintained on extended treatment interval with injections every other month.
Aflibercept solution for injection into the eye has been approved under the brand name EYLEA® in many countries for the treatment of patients with 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 Japan, Asia Pacific, Latin America and the U.S. for the treatment of Diabetic Macular Edema. 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 (BRVO).
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 licensed the exclusive marketing rights outside the United States, wher the companies share equally the profits from sales of EYLEA, except for Japan wher Regeneron receives a percentage of net sales.
about Diabetic Macular Edema (DME)
DME is a common complication of Diabetic Retinopathy, 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.
DME is the most frequent cause of blindness in young and mid-aged adults in most developed countries. The treatable population for DME globally is estimatedatabout 6.2 million people. The incidence of diabetes has been steadily climbing and it is projected that up to seven percent of all patients with diabetes will develop DME during their lifetime.
about VEGF and 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.
Aflibercept solution for injection 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.
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 commercializes 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, 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 18.9 billion (2013), 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 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.
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