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eylea批准用于年龄相关性黄斑变性,美国

Eylea Approved For Age-related Macular Degeneration, USA
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Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Nov 2011 - 8:00 PST

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Eylea (aflibercept) has been approved by the FDA for wet AMD (age-related macular degeneration). Wet (neovascular) AMD is one of the main causes of blindness or vision impairment in older Americans - by affecting the part of the eye that allows us to see fine detail (the macula), it destroys our sharp central vision. Such daily tasks as reading, writing and driving become more and more difficult.

Eylea has been approved at a dose of 2 mg once per month for the first 12 weeks, and then 2 mg once every two months.

The new intravitreal injection administration, as is done with Eylea, is known in scientific literature as VEGF Trap-Eye.

In most cases of wet AMD, although central vision can become severely affected, the patients' peripheral vision still allows them to get about unaided.

There are two types of macular degeneration :
Dry macular degeneration - this form progresses gradually. Although there is no treatment, things can be done to help the patient cope with it.
Wet macular degeneration - this one progresses much more rapidly; it involves the growth of abnormal blood vessels (neovascularization) which leak fluid into the macula (center of the retina). Treatment is needed as soon as symptoms appear. One of the first symptoms includes seeing straight lines as wavy ones. This type is more serious than dry AMD.


How an AMD patient might see these two boys

How a person with good vision would see the two boys

Edward Cox, M.D., M.P.H, Director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, said:


"Eylea is an important new treatment option for adults with wet AMD. It is a potentially blinding disease and the availability of new treatment options is important."




The FDA evaluated two Phase 3 clinical studies which included 2,412 participants, all with wet AMD. They were randomly selected into two groups:
The Eylea group - aflibercept injection into the eye, either once every four or eight weeks, administered by an ophthalmologist (specialist eye doctor)
The Lucentis group - ranibizumab injection into the eye, also administered by an ophthalmologist
The primary endpoint in both cases was patients' visual acuity (clearness of vision) after 12 months' treatment. The primary endpoint means the "main result" measured at the end of a trial to determine whether a given treatment worked.

Both studies demonstrated that Eylea is as effective as Lucentis in either improving or maintaining visual acuity.

Among those in the Eylea group, the most common (reported) side effects included conjunctival hemorrhage (bleeding at injection site), eye pain, vitreous floaters (seeing spots floating around in one's vision), cataract (clouding of the lens of the eye), and elevated eye pressure.

Patients with a currently active eye infection or ocular inflammation should not be given Eylea. No Eylea studies have been carried out on pregnant patients - the FDA says doctors should only use this medication for pregnant mothers if they are sure the potential benefits outweigh the potential risks. Eylea has not been studied in children (wet AMD is not a pediatric condition).

FDA-approved medications for wet AMD, apart from newly approved Eylea, include verteporfin for injection (Visudyne), pegaptanib sodium injection (Macugen), and ranibizumab injection (Lucentis).

Clinical ophthalmologist and retinal specialist, Jeffrey Heier, M.D., Chair of the Steering Committee for the VIEW 1 trial, said:


"The approval of EYLEA offers a much needed new treatment option for patients with wet AMD. EYLEA offers the potential of achieving the efficacy we've come to expect from current anti-VEGF agents, but with less frequent injections and no monitoring requirements. This may reduce the need for costly and time-consuming monthly office visits for patients and their caregivers."


Eylea is marketed in the USA by Regeneron Pharmaceuticals Inc.

Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron, said:


"This approval is an important step forward for Regeneron and for patients suffering with wet AMD, the most common cause of blindness in the U.S. in older adults. We thank the patients and clinical investigators who participated in our clinical studies, the FDA, and the Regeneron employees who helped make this day possible. Now that EYLEA is approved, we plan to make EYLEA available to patients within the next few days."


Written by Christian Nordqvist


View drug information on Lucentis; Macugen; Visudyne.

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20 Nov. 2011. <http://www.medicalnewstoday.com/articles/237985.php>
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Visitor Opinions In Chronological Order (1)
good news for AMD patients
posted by Anthony Nazar on 20 Nov 2011 at 8:56 am
As a wet AMD patient, I have been receiving both Avastin and Lucentis injections, first in my left eye five years ago, then in my right eye beginning about 2-3 years ago. My left eye was too badly damaged in the initial bleed to make a huge difference. It has become my Monet eye. As a photographer, my right eye is all important. It remains stable, but I look forward to receiving an Eylea injection and hope it will go where Lucentis hasn't thus far.

I am forever grateful to researchers and my doctor for a treatment that wasn't possible six or seven years ago..

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生命不息,战斗不止。
不晓得有没有中文版的!
Eylea年龄相关性黄斑变性,美国批准
编辑选择奖
主要分类:健康/失明的眼睛
中还包括:监管部/***审批
文章日期:2011年11月20日 - 8:00 PST

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条意见:1职位

Eylea(aflibercept)已被FDA批准为湿性AMD(年龄相关性黄斑变性)。湿性(新生血管性)AMD是美国老年人失明或视力受损的主要原因之一 - 受影响的眼睛,让我们看到了精致的细节(黄斑)的一部分,它破坏了我们锐利的中央视力。这些日常任务,如阅读,写作和驾驶变得越来越难。

Eylea已批准2毫克剂量第12周每月一次,然后2毫克每两个月一次。

新的玻璃体内注射给药,与Eylea,被称为血管内皮生长因子陷阱眼科学文献。

在大多数情况下,湿性AMD虽然可以成为严重影响中央视力,病人的周边视力仍然允许他们获得约肉眼。

性黄斑变性有两种类型:
干性黄斑变性 - 这种形式逐渐进步。虽然目前还没有治疗,事情可以做,以帮助病人配合。
湿性黄斑变性 - 这个过程更迅速,它涉及到流体泄漏到黄斑部(视网膜中心)的异常血管(新生血管)的增长。只要出现症状需要治疗。最早出现的症状之一,包括看到波浪的直线。此类型较干性AMD严重。


AMD的病人可能会看到这两个男孩

如何与人良好的视力会看到两个男孩

爱德华考克斯,医学博士,公共卫生硕士,抗菌产品在FDA的药物评价和研究中心的办公室主任,说:


“Eylea***湿性AMD是一个重要的的新的治疗选择,这是一个潜在的致盲性疾病提供新的治疗方案是很重要的。”




FDA的评估两个阶段,其中包括2412所有参与者与湿性AMD,临床研究。他们被随机分成两组选择:
Eylea集团 - aflibercept注射进入眼内,无论是每隔四周或八周,由眼科医生(专科眼科医师)管理
Lucentis的组 - 兰尼单抗注射到眼睛,也由眼科医生管理
在这两种情况下的主要终点是12个月的治疗后患者的视力(视野清晰)。主要终点是指在审讯结束时测量,以确定是否一个给定的治疗工作“的主要结果”。

这两项研究表明,Eylea如Lucentis的有效改善或保持视力。

在Eylea组,的最常见的(报道)侧的影响,包括结膜出血(注射部位出血),眼痛,看到斑点漂浮在一个人的视野周围玻璃体飞蚊症,白内障(眼球晶状体混浊) ,并升高眼内压。

目前活跃的眼部感染或眼部炎症的患者不宜给予Eylea。没有Eylea研究已怀孕的患者进行了 - FDA表示,医生应该只使用这对孕妇的用药,如果他们确定的潜在利益大于潜在的风险。 Eylea尚未研究儿童(湿性AMD是不是儿科的条件)。

FDA批准的湿性AMD的药物,除了新批准的Eylea,包括注射用维替泊芬(Visudyne),pegaptanib钠注射液(药物Macugen),兰尼单抗注射液(Lucentis的)。

临床眼科医生和视网膜专家,视图的1审判指导委员会主席杰弗里黑尔,MD,说:


“EYLEA批准提供了湿性AMD患者急需新的治疗选择。EYLEA提供的实现我们期望从目前的抗VEGF药物的疗效的潜力,但与降低注射的频率,并没有监测的要求。可减少昂贵和费时的病人和他们的照顾者,每月的办公室访问的需要。“


Eylea Regeneron公司制药公司在美国上市

Regeneron公司总裁兼行政总裁,医学博士,哲学博士,伦纳德S · Schleifer,说:


“这个批准是Regeneron公司和患者患湿性AMD,在美国老年人失明的最常见的原因提出了重要的一步,我们感谢患者参加我们的临床研究,FDA的临床调查,并Regeneron公司员工谁帮助使这一天成为可能。EYLEA被批准,我们计划使EYLEA在未来几天内患者。“


书面基督教Nordqvist


查看信息药物Lucentis的药物Macugen; Visudyne。

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按时间顺序排列的观众意见(1)
AMD患者的好消息
发表于2011年11月20日上午在8:56安东尼纳扎尔
由于湿性AMD的病人,我一直在接受Avastin和Lucentis的注射剂,在我的左眼首先在五年前,在我的右眼开始,然后大约在2-3年前。我的左眼是太严重损坏在最初的出血,做出了巨大的差异。它已成为我的莫奈眼睛。作为一个摄影师,我的右眼是最重要的。保持稳定,但是,我期待着收到Eylea注射,并希望它会去哪里Lucentis的迄今尚未。

我研究人员和医生的治疗是不可能的六,七年前我永远感激..

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