– Bayer has submitted an application to the European Medicines Agency (EMA) to expand treatment intervals of up to 6 months with Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME)..

–拜耳已向欧洲药品管理局（EMA）提交申请，将Eylea™8 mg（阿柏西普8 mg，114.3 mg/ml注射溶液）的治疗间隔延长至6个月，用于治疗两种主要的视网膜疾病，即新生血管（湿性）年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）。。

The submission is based on positive three-year results from open-label extension studies of the clinical trials PULSAR, in nAMD and PHOTON, in DME. In both extension studies patients randomized to Eylea 8 mg from baseline maintained their visual and anatomic improvements, with 28% of patients in DME and 24% of patients in nAMD having a last assigned dosing interval of 6 months at the end of three years..

提交的材料基于临床试验PULSAR在nAMD和PHOTON在DME中的开放标签扩展研究的三年积极结果。在这两项扩展研究中，从基线随机分配到Eylea 8 mg的患者保持了视觉和解剖学的改善，28%的DME患者和24%的nAMD患者在三年结束时的最后指定给药间隔为6个月。。

“Longer dosing intervals address a critical unmet medical need and offer patients living with retinal diseases greater flexibility and a reduced burden from frequent injections and hospital visits. This is also important to those that care for these patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer.

拜耳全球产品战略和商业化执行副总裁兼制药领导团队成员克里斯蒂娜·罗斯（Christine Roth）表示：“更长的给药间隔可以满足严重的未满足医疗需求，为患有视网膜疾病的患者提供更大的灵活性，减轻频繁注射和住院的负担。这对照顾这些患者的人也很重要。”。

“Eylea 8 mg was the first anti-VEGF to receive a 5-month label in the EU, and the new data support a substantial proportion of patients have the potential to maintain 6-month extended treatment intervals.”.

“Eylea 8 mg 是第一个在欧盟获得 5 个月标签的抗 VEGF，新数据支持很大一部分患者有可能维持 6 个月的延长治疗间隔。”

The safety profile of Eylea 8 mg continued to be favorable in the third year in both studies and is consistent with the well-established safety profile of Eylea 2 mg. The long-term safety data did not show any new signals in both trials, including patients switching from Eylea 2 mg to Eylea 8 mg. The rates for ocular treatment emergent adverse events were similar in all treatment groups..

在两项研究中，Eylea 8 mg的安全性在第三年继续保持良好，并且与Eylea 2 mg的公认安全性一致。长期安全性数据在两项试验中均未显示任何新信号，包括从Eylea 2 mg转换为Eylea 8 mg的患者。所有治疗组眼部治疗紧急不良事件的发生率相似。。

Eylea™ 8 mg (aflibercept 8 mg) has been approved to date in more than 50 markets for the treatment of nAMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing.

迄今为止，Eylea™8 mg（aflibercept 8 mg）已在50多个市场获得批准，用于治疗nAMD和DME。Eylea 8 mg在其他市场的进一步监管申请正在进行中。

Eylea is a global market leader for the treatment of retinal eye diseases with anti-vascular endothelial growth factors (anti-VEGF), with more than 85 million applications and more than 12 million patient-years of experience worldwide.

Eylea是用抗血管内皮生长因子（抗VEGF）治疗视网膜眼病的全球市场领导者，在全球范围内有超过8500万的应用和超过1200万患者年的经验。

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..

拜耳和Regeneron正在联合开发Eylea 8 mg（阿柏西普8 mg；在美国：Eylea HD）。Regeneron在美国拥有Eylea 2 mg（aflibercept 2 mg）和Eylea HD的专有权。拜耳已获得美国境外独家营销权的许可，在美国，两家公司平均分享Eylea 2 mg和Eylea 8 mg的销售利润。。

About nAMD and DME

关于nAMD和DME

Neovascular (wet) age-related macular degeneration (nAMD) is an eye disease that progresses rapidly and if left untreated can lead to vision loss in a few months. nAMD is one of the leading causes of irreversible blindness and vision impairment around the world. nAMD may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail.

新生血管（湿性）年龄相关性黄斑变性（nAMD）是一种进展迅速的眼部疾病，如果不及时治疗，可能会在几个月内导致视力下降。。nAMD可能会随着年龄的增长而影响人们。当异常血管生长并在黄斑下渗漏液体时，就会发生这种情况。黄斑是眼睛的一部分，负责敏锐的中央视力和看到细微的细节。

This fluid can damage and scar the macula, which can cause vision loss. 170 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040. Approximately 10% of people with AMD will develop the advanced form nAMD..

这种液体会损害黄斑并留下疤痕，从而导致视力下降。全世界有1.7亿人患有AMD，预计到2040年，这一数字将增加到2.88亿。大约10%的AMD患者将开发高级形式的nAMD。。

Diabetic macular edema (DME) is a common complication in eyes of people living with diabetes. DME occurs when high levels of blood sugar leads to damaged blood vessels in the eye that leak fluid into the macula. This can lead to vision loss and, in some cases, blindness. Globally, 146 million people are currently living with diabetic retinopathy (DR), which can develop into a more serious condition which is diabetic macular edema.

糖尿病性黄斑水肿（DME）是糖尿病患者眼中常见的并发症。当高血糖导致眼部血管受损，液体泄漏到黄斑时，就会发生DME。这可能导致视力丧失，在某些情况下还会导致失明。在全球范围内，目前有1.46亿人患有糖尿病视网膜病变（DR），这可能会发展为更严重的疾病，即糖尿病性黄斑水肿。

DME affects around 27 million people globally..

DME影响全球约2700万人。。

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.

拜耳是一家全球性企业，在医疗保健和营养等生命科学领域拥有核心竞争力。根据其“人人健康，无人饥饿”的使命，该公司的产品和服务旨在通过支持应对全球人口不断增长和老龄化带来的重大挑战，帮助人们和地球繁荣发展。

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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros.

拜耳致力于推动可持续发展，并对其业务产生积极影响。与此同时，该集团旨在通过创新和增长来提高其盈利能力和创造价值。拜耳品牌代表着全世界的信任、可靠性和质量。2023财年，该集团雇佣了约10万人，销售额476亿欧元。