– Bayer has submitted an application to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval of aflibercept 8 mg (114.3 mg/ml solution for injection) for the treatment of patients with macular edema following retinal vein occlusion (RVO) including central, branch and hemiretinal vein occlusion.

– 拜耳已向日本厚生劳动省 (MHLW) 提交了申请，寻求批准使用阿柏西普 8 mg（114.3 mg/ml 注射液）用于治疗视网膜静脉阻塞（包括中央、分支和半侧视网膜静脉阻塞）后黄斑水肿的患者。

In Japan, this would be the third indication for aflibercept 8 mg supporting the blockbuster status of Eylea.

在日本，这将是阿柏西普8毫克的第三个适应症，支持了Eylea的重磅地位。

The submission to the MHLW is supported by favorable outcomes from the global randomized, double-masked, active-controlled phase III QUASAR study. The study was conducted in RVO patients from 27 countries, including Japan. This study achieved its primary endpoint at week 36, showing that patients treated with aflibercept 8 mg every 8 weeks (following 3 or 5 initial monthly doses) achieved visual acuity improvements that were non-inferior to patients receiving the current standard treatment, Eylea™ 2 mg (aflibercept 2 mg) every 4 weeks..

向日本厚生劳动省提交的申请得到了全球随机、双盲、活性对照的III期QUASAR研究的良好结果的支持。该研究在来自27个国家（包括日本）的RVO患者中进行。这项研究在第36周达到了其主要终点，结果显示，每8周接受一次aflibercept 8 mg治疗的患者（在最初3或5个月的剂量后），其视力改善效果不劣于每4周接受当前标准治疗Eylea™ 2 mg（aflibercept 2 mg）的患者。

“Japan is an important market for Bayer in ophthalmology and today's submission marks a significant step towards enhancing patient care in retinal vein occlusion,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer.

“日本是拜耳在眼科领域的重要市场，今天的提交标志着我们在视网膜静脉阻塞方面提升患者护理迈出了重要的一步，”拜耳制药执行副总裁、全球产品战略与商业化负责人、拜耳制药领导团队成员克里斯汀·罗斯表示。

“Following approval in Japan, aflibercept 8 mg may offer extended treatment intervals for patients affected by macular edema due to retinal vein occlusion, thereby reducing the burden of frequent injections and clinic visits.”.

“在日本获批后，阿柏西普8毫克可能会为视网膜静脉阻塞导致的黄斑水肿患者提供更长的治疗间隔，从而减轻频繁注射和门诊就诊的负担。”

The QUASAR clinical study demonstrated that approximately 90% of patients on aflibercept 8 mg maintained their extended 8-week dosing intervals through 36 weeks, and almost 70% of patients (in the group with 3 initial monthly dosing) had a last assigned dosing interval of 12 weeks. Importantly, fluid reduction – an indicator of disease control – was similar with extended dosing intervals of aflibercept 8 mg compared with monthly doses of Eylea 2 mg.

QUASAR 临床研究显示，大约 90% 使用 8 mg 阿柏西普的患者在 36 周内维持了 8 周的延长给药间隔，而在接受最初每月给药的患者组中，近 70% 的患者最后分配的给药间隔达到了 12 周。重要的是，与每月使用 2 mg Eylea（艾力雅）相比，使用 8 mg 阿柏西普延长给药间隔后，液体减少（疾病控制的一个指标）的效果相似。

Additionally, aflibercept 8 mg was well tolerated, and its safety profile was consistent with 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一致。

Eylea 8 mg has been approved to date in more than 50 markets for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). Further regulatory applications for Eylea 8 mg in additional markets are ongoing.

截至目前，Eylea 8 mg已在50多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在更多市场的进一步监管申请正在进行中。

Eylea 8 mg is the only anti-vascular endothelial growth factor-treatment (anti-VEGF) that is approved for extended treatment intervals of up to 5 months for both, nAMD and DME, in the EU and UK. In February 2025, Bayer submitted an application to EMA to expand treatment intervals to up to 6 months with Eylea 8 mg for the treatment of nAMD and DME based on clinical evidence from the PULSAR and PHOTON studies..

Eylea 8 mg 是欧盟和英国唯一获批的抗血管内皮生长因子（抗VEGF）疗法，可用于治疗间隔长达5个月的nAMD和DME。2025年2月，拜耳基于PULSAR和PHOTON研究的临床证据，向欧洲药品管理局（EMA）提交了申请，希望将Eylea 8 mg的治疗间隔扩展至最长6个月，用于治疗nAMD和DME。

Eylea 8 mg (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..

Eylea 8 mg（阿柏西普 8 mg；在美国：Eylea HD）由拜耳和再生元共同开发。再生元保留在美国对 Eylea 2 mg（阿柏西普 2 mg）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 mg 和 Eylea 8 mg 的销售利润。

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，可能导致突发性、快速的视力丧失。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出现阻塞时。

BRVO occurs when the smaller, branch retinal veins are obstructed, and is up to six times more common than CRVO. RVO leads to a reduced oxygen supply to the retina, increasing the production of vascular endothelial growth factor (VEGF) and placental growth factor (PlGF). The blocked vein can cause fluid and blood to leak into the retina resulting in a swelling and bleeding of the macula, the centre of the retina responsible for fine vision.

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。RVO会导致视网膜的氧气供应减少，增加血管内皮生长因子（VEGF）和胎盘生长因子（PlGF）的产生。被阻塞的静脉可能导致液体和血液渗漏到视网膜，从而引起黄斑（视网膜中心，负责精细视觉的部分）肿胀和出血。

This swelling is called macular edema, and VEGF plays a major role in driving this pathology..

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，无饥饿”的使命，公司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，设计其产品和服务以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.

拜耳致力于推动可持续发展，并通过其业务产生积极影响。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，该集团拥有约93,000名员工，销售额达466亿欧元。