阿柏西普 8 mg获推荐欧盟批准用于第三种视网膜适应症-动脉网

Aflibercept 8 mg recommended for EU approval for third retinal indication

拜耳等信源发布 2025-12-12 22:01

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December

十二月

2025

15:00 PM

Europe/Amsterdam

欧洲/阿姆斯特丹

Aflibercept 8 mg recommended for EU approval for third retinal indication

阿柏西普8毫克获推荐欧盟批准用于第三种视网膜适应症

Not intended for U.S. and UK Media

不适用于美国和英国媒体

Summary

摘要

Positive opinion of the Committee for Medicinal Products for Human Use (CHMP) is based on the outcomes from the clinical Phase III trial QUASAR in patients with macular edema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion / Aflibercept 8 mg demonstrated non-inferior visual acuity gains and robust fluid control with extended treatment intervals as well as fewer injections, compared to Eylea™ 2 mg monthly / The decision of the European Commission is expected within the next weeks.

人用药品委员会（CHMP）的积极意见是基于QUASAR临床III期试验的结果，该试验针对视网膜静脉阻塞（RVO）后黄斑水肿患者，包括分支、中央和半侧视网膜静脉阻塞 / Aflibercept 8 mg显示出与Eylea™ 2 mg每月注射相比，在延长治疗间隔和减少注射次数的情况下，非劣效的视力增益和强劲的液体控制能力 / 欧洲委员会的决定预计将在未来几周内公布。

Berlin, December 12, 2025

柏林，2025年12月12日

– The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended aflibercept 8 mg (114.3 mg/ml solution for injection) for marketing authorization in the European Union (EU) for the treatment of patients with visual impairment due to macular edema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion.

欧盟药品管理局（EMA）的人用药品委员会（CHMP）已推荐批准8毫克阿柏西普（114.3毫克/毫升注射液）在欧盟（EU）上市，用于治疗因视网膜静脉阻塞（RVO）引起的黄斑水肿导致视力受损的患者，包括分支、中央和半侧视网膜静脉阻塞。

The European Commission’s decision is anticipated within the coming weeks, which would mark the third indication for Eylea 8 mg..

欧洲委员会的决定预计将在未来几周内做出，这将是Eylea 8 mg的第三个适应症。

“Following the approval of Eylea 8 mg for treatment intervals of up to six months in neovascular age-related macular degeneration and diabetic macular edema in the EU, today's recommendation marks a significant step towards advancing the treatment of retinal vein occlusion. Aflibercept 8 mg is set to enhance the standard of care, reducing the burden of frequent injections and clinic visits for patients experiencing macular edema due to retinal vein occlusion, without compromising efficacy and safety,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer..

“继Eylea 8 mg在欧盟获批用于治疗间隔最长为六个月的新生血管性年龄相关性黄斑变性和糖尿病性黄斑水肿后，今天的推荐标志着在视网膜静脉阻塞治疗方面迈出了重要一步。阿柏西普8 mg将提升护理标准，在不降低疗效和安全性的前提下，减少因视网膜静脉阻塞导致黄斑水肿的患者频繁注射和门诊就诊的负担，”拜耳制药执行副总裁、全球产品战略与商业化负责人及制药领导团队成员克里斯汀·罗斯表示。

The QUASAR clinical study met its primary endpoint at week 36, demonstrating that patients receiving aflibercept 8 mg every 2 months (after 3 or 5 initial monthly injections) achieved non-inferior visual acuity gains and robust fluid control compared to those receiving Eylea 2 mg (aflibercept 2 mg) monthly.

QUASAR 临床研究在第 36 周达到了主要终点，证明接受每两个月一次 8 毫克阿柏西普治疗的患者（在最初每月注射 3 或 5 次之后）与每月接受 2 毫克 Eylea（阿柏西普 2 毫克）治疗的患者相比，获得了非劣效的视力增益和强劲的液体控制。

Additional submitted data show that visual acuity was maintained with aflibercept 8 mg, and unparalleled durability was demonstrated through the end of the study at week 64. More than 60% of patients receiving aflibercept 8 mg were able to extend their treatment intervals to four months and longer, with 40% having a last assigned interval of five months..

额外提交的数据表明，使用阿柏西普8 mg可维持视力，并且在第64周研究结束时展现了无与伦比的持久性。超过60%接受阿柏西普8 mg治疗的患者能够将治疗间隔延长至四个月或更长时间，其中40%的患者最后一次分配的治疗间隔为五个月。

The number of injections, a key secondary endpoint, was significantly reduced to 8.4 injections with aflibercept 8 mg administered every two months (after three initial monthly injections), compared to 11.7 with Eylea 2 mg by week 64. Importantly, fluid reduction – an indicator of disease control – was similar with extended dosing intervals of aflibercept 8 mg compared with dosing intervals of Eylea 2 mg.

注射次数（一个关键的次要终点）显著减少，在第64周时，每两个月注射一次8毫克阿柏西普（初始三个月每月注射一次后）的平均注射次数为8.4次，而2毫克Eylea的平均注射次数为11.7次。重要的是，与2毫克Eylea的给药间隔相比，使用8毫克阿柏西普延长给药间隔后的液体减少（疾病控制的一个指标）效果相似。

Additionally, aflibercept 8 mg was well tolerated, and its safety profile was consistent with results from previous clinical trials..

此外，阿柏西普8毫克的耐受性良好，其安全性与之前的临床试验结果一致。

Eylea 8 mg has been approved to date in more than 60 markets for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Eylea 8 mg 已在超过60个市场获批用于治疗新生血管性（湿性）年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）。

Eylea 8 mg is the first and only anti-vascular endothelial growth factor-treatment (anti-VEGF) that is approved for extended treatment intervals of up to 6 months both in nAMD and DME in the EU and UK.

Eylea 8 mg 是欧盟和英国首个也是唯一一个获批用于延长治疗间隔（最长可达6个月）的抗血管内皮生长因子（抗VEGF）药物，适用于nAMD和DME。

Aflibercept 8 mg (in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg..

阿柏西普8毫克（美国商品名：Eylea HD）由拜耳和再生元公司共同开发。再生元公司在美国拥有Eylea 2毫克（阿柏西普2毫克）和Eylea HD的独家权利。拜耳获得了美国以外的独家营销权，两家公司平分Eylea 2毫克和Eylea 8毫克的销售利润。

About QUASAR

关于QUASAR

The QUASAR trial is a global randomized, double-masked, active-controlled Phase III study evaluating the efficacy and safety of aflibercept 8 mg used with extended dosing intervals in treatment-naïve patients with macular edema secondary to retinal vein occlusion including branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO), and hemiretinal vein occlusion (HRVO).

QUASAR 试验是一项全球随机、双盲、活性对照的 III 期研究，评估了在因视网膜静脉阻塞（包括分支视网膜静脉阻塞 (BRVO)、中央视网膜静脉阻塞 (CRVO) 和半侧视网膜静脉阻塞 (HRVO)）导致黄斑水肿的初治患者中，使用延长给药间隔的阿柏西普 8 mg 的疗效和安全性。

The primary endpoint of this study is the change in best corrected visual acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, from baseline to week 36 of treatment. The study compared BCVA changes between patients who received aflibercept 8 mg every 8 weeks following either 3 or 5 initial monthly doses compared to aflibercept.

本研究的主要终点是从基线到治疗第36周，通过早期糖尿病视网膜病变治疗研究（ETDRS）字母评分测量的最佳矫正视力（BCVA）的变化。该研究比较了在接受3或5次初始每月剂量后每8周接受一次阿柏西普8 mg的患者与阿柏西普之间的BCVA变化。

2 mg every 4 weeks. Treatment intervals could be further adjusted based on treatment response continuously evaluated under clinically relevant dose regimen modification (DRM) criteria. Treatment intervals could be shortened by 4 weeks at any visit if patients met DRM criteria. Treatment intervals could be extended at dosing visits based on DRM criteria from week 32 (for the study arms with aflibercept 2 mg and aflibercept 8 mg following 3 initial monthly doses) or week 40 (for the study arm with aflibercept 8 mg following 5 initial monthly doses).

每4周2毫克。可以根据在临床相关剂量调整（DRM）标准下持续评估的治疗反应进一步调整治疗间隔。如果患者符合DRM标准，可在任何就诊时将治疗间隔缩短4周。根据DRM标准，治疗间隔可从第32周（针对接受3次初始每月剂量后使用阿柏西普2毫克和阿柏西普8毫克的研究组）或第40周（针对接受5次初始每月剂量后使用阿柏西普8毫克的研究组）起在给药就诊时延长。

Patients were treated up to week 60 followed by a monitoring period through week 64. The trial enrolled more than 800 patients from 27 countries..

患者治疗持续至第60周，随后进入至第64周的监测期。该试验招募了来自27个国家的800多名患者。

About RVO

关于RVO

Retinal vein occlusion (RVO) is a chronic condition that currently affects 28 million adults globally and can lead to sudden, rapid vision loss. There are two main types of RVO - central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). CRVO occurs when there is a blockage in the main vein of the retina at the optic nerve.

视网膜静脉阻塞（RVO）是一种慢性疾病，目前全球有2800万成年人受到影响，可能导致突然且迅速的视力丧失。RVO主要有两种类型：中央视网膜静脉阻塞（CRVO）和分支视网膜静脉阻塞（BRVO）。CRVO发生在视神经处视网膜主静脉阻塞时。

BRVO occurs when the smaller, branch retinal veins are obstructed, and is up to six times more common than CRVO. Hemiretinal vein occlusion (HRVO) refers to the occlusion of a superior vein that supplies one half of the retina. RVO leads to a reduced oxygen supply to the retina, increasing the production of vascular endothelial growth factor (VEGF) and placental growth factor (PlGF).

当较小的分支视网膜静脉受阻时会发生BRVO，其发生率比CRVO高出六倍。半侧视网膜静脉阻塞（HRVO）指的是供应一半视网膜的上侧静脉阻塞。RVO导致视网膜供氧减少，增加血管内皮生长因子（VEGF）和胎盘生长因子（PlGF）的产生。

The blocked vein can cause fluid and blood to leak into the retina resulting in swelling and bleeding within the macula, the central field of vision, including visualizing fine details. This swelling is called macular edema, and VEGF plays a major role in driving this pathology..

阻塞的静脉会导致液体和血液渗漏到视网膜，从而导致黄斑（中央视野，包括可视化细节的部分）内部肿胀和出血。这种肿胀被称为黄斑水肿，VEGF在驱动这种病理过程中起着重要作用。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无人饥饿”的使命，公司的产品和服务旨在通过支持应对不断增长和老龄化的全球人口所带来的重大挑战，帮助人类和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于通过其业务推动可持续发展并产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表信任、可靠性和质量。在2024财年，集团拥有约93,000名员工，销售额达466亿欧元。

R&D expenses amounted to 6.2 billion euros. For more information, go to .

研发费用共计62亿欧元。欲了解更多信息，请访问。

www.bayer.com

。

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Forward-Looking Statements

前瞻性声明

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

本发布可能包含基于拜耳管理层当前假设和预测的前瞻性声明。各种已知和未知的风险、不确定性和其他因素可能导致公司的实际未来结果、财务状况、发展或业绩与这里给出的估计存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at .

这些因素包括拜耳公开报告中讨论的因素，这些报告可在拜耳网站上查阅。

www.bayer.com

. The company assumes no liability whatsoever to update these forward-looking statements or to conform

公司不承担更新这些前瞻性声明或使其符合的任何责任。

them to future events or developments.

将它们应用于未来的事件或发展。

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