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拜耳Eylea 2个III期糖尿病性黄斑水肿试验均达主要终点

  1. Eylea
  2. Regeneron
  3. 拜耳
  4. 糖尿病性黄斑水肿

来源:生物谷 2013-08-06 17:41

2013年8月6日讯 /生物谷BIOON/ --Regeneron制药和拜耳(Bayer)今天宣布,有关眼科药物Eylea(aflibercept,阿柏西普注射液)治疗糖尿病性黄斑水肿(DME)的2个III期试验VIVID-DME和VISTA-DME均达到了研究的主要终点。

2013年8月6日讯 /生物谷BIOON/ --Regeneron制药和拜耳(Bayer)今天宣布,有关眼科药物Eylea(aflibercept,阿柏西普注射液)治疗糖尿病性黄斑水肿(DME)的2个III期试验VIVID-DME和VISTA-DME均达到了研究的主要终点。治疗52周时,最佳矫正视力(BCVA)从基线的变化,与激光光凝(laser photocoagulation)相比,Eylea治疗组取得了显着的更大改善。2项试验中,Eylea治疗组均表现出了相似的BCVA改善。

基于与FDA之间的讨论,Regeneron制药计划在2013年提交Eylea治疗DME的上市申请,这比此前宣布的时间提前了一年。拜耳则计划在2013年向欧洲药品管理局(EMA)提交Eylea治疗DME的上市许可申请(MAA)。

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。

这些实验中,Eylea的耐受性良好,整体不良事件(AEs)、眼部严重AEs、非眼部严重AEs发生率在治疗组和激光组相似。

VIVID-DME和VISTA-DME试验计划继续开展至148周,2个试验的1年期数据,将提交至即将召开的医学会议。

Eylea于2011年11月获FDA批准,用于新生血管性(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也已获欧盟、日本、澳大利亚及其他国家批准用于治疗wet-AMD。

自从获批以来,Eylea就在不断地蚕食罗氏(Roche)类似药物Lucentis的市场份额,这使得Regeneron一再地上调Eylea的销售预期。目前,该公司预计Eylea在2013年的销售额将达到12.5亿-13.3亿美元。

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:Regeneron's Eylea improves vision in diabetic eye condition

Aug 6 (Reuters) - Regeneron Pharmaceuticals Inc's Eylea helped improve the vision of patients with diabetic macular edema (DME) significantly better than laser surgery in a pair of late-stage clinical trials, paving the way for an expanded approval of the sight-saving medicine, the company said on Tuesday.

Eylea is already approved to treat wet age-related macular edema, the leading cause of blindness in the elderly.

The condition associated with diabetes is the leading cause of blindness in younger and middle aged adults, with potentially more than 6 million treatable patients worldwide, the U.S. biotechnology company said.

As a result of the two successful trials, called Vivid-DME and Vista-DME, Regeneron said it plans to apply for U.S. approval to treat diabetic macular edema in 2013 - a year ahead of its previously projected timeline.

Bayer AG, which sells the drug outside the United States, also will apply for European DME approval this year.

Patients in the two year-long studies received either monthly injections of Eylea, or injections every other month following a course of five monthly injections. Eylea treatment was compared with laser photocoagulation, a type of laser surgery in which leaky blood vessels in the eye are cauterized to stop the leakage that leads to vision loss.

In the Vista-DME trial, those who received monthly Eylea on average were able to see 12.5 more letters on an eye chart test after one year, than prior to receiving treatment. Those in the every other month group saw vision improve by 10.7 letters. That compared with a mean change of just 0.2 letters for the laser group.

In the Vivid-DME trial the vision improvements were 10.5 letters and 10.7 letters for the Eylea monthly and less frequent dosing groups, respectively, versus an improvement of 1.2 letters for those who received laser treatment.

All the results for Eylea were deemed by researchers to be highly statistically significant.

Eylea was generally well tolerated in the studies with the incidence of serious adverse side effects similar across all three treatment groups, the company said.

The drug was first approved in November of 2011 for wet age-related macular degeneration and received an additional approval a year later to treat macular edema following a condition known as central retinal vein occlusion.

It has been grabbing market share from Roche Holding's similar Lucentis, leading Regeneron to repeatedly increase Eylea sales forecasts since its approval.

 

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