– Bayer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a label extension for Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection). This extension allows for expanded treatment intervals of up to 6 months for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) following approval by the European Commission.

– 拜耳今天宣布，欧洲药品管理局（EMA）人用医药产品委员会（CHMP）已发布积极意见，建议批准延长Eylea™ 8 mg（阿柏西普8 mg，114.3 mg/ml注射液）的标签适应症。该扩展允许在欧洲委员会批准后，将两种主要视网膜疾病的治疗间隔延长至最长6个月，这两种疾病分别是新生血管性（湿性）年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）。

The decision of the European Commission is expected within the next few weeks and if approved, Eylea 8 mg would be the only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both nAMD and DME..

预计欧洲委员会的决定将在未来几周内公布，如果获得批准，Eylea 8 mg 将成为欧盟唯一一种治疗间隔长达6个月的抗血管内皮生长因子（VEGF）药物，适用于nAMD和DME。

“Following approval of the European Commission, extended treatment intervals with Eylea 8 mg of up to 6 months can significantly reduce the frequency of injections and visits to the clinic for patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

“在获得欧盟委员会批准后，使用Eylea 8 mg延长治疗间隔至最长6个月，可显著减少患者的注射频率和前往诊所的次数，”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。

“These extended intervals, combined with the unique product profile of Eylea 8 mg, position it to become a new standard of care for retinal diseases.”.

“这些延长的间隔时间，加上Eylea 8 mg的独特产品特性，使其有望成为视网膜疾病治疗的新标准。”

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

CHMP 的意见基于关键临床试验 PULSAR（针对 nAMD）和 PHOTON（针对 DME）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，随机分配到 8 mg Eylea 的患者在基线时保持了视力和解剖学改善，其中 24% 的 nAMD 患者和 28% 的 DME 患者在三年结束时最后一次分配的给药间隔为 6 个月。

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 for patients switching from Eylea 2 mg to Eylea 8 mg. The rates for ocular treatment emergent adverse events were similar across all treatment groups..

Eylea 8 mg 在两项研究的第三年中继续保持良好的安全性，与已确立的 Eylea 2 mg 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 转换到 Eylea 8 mg 的患者。各治疗组之间的眼部治疗相关不良事件发生率相似。

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. 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 (after 3 initial monthly injections) for both nAMD and DME, in the EU and UK..

Eylea™ 8 mg（阿柏西普 8 mg）已在超过50个市场获批用于治疗新生血管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。在欧盟和英国，Eylea 8 mg是唯一获批可将治疗间隔延长至最长5个月（在最初3次每月注射后）的抗血管内皮生长因子（抗-VEGF）疗法，适用于nAMD和DME。

Eylea is a global market leader for the treatment of retinal eye diseases with anti-vascular endothelial growth factors (anti-VEGF), with more than 88 million applications and more than 12 million patient-years of experience worldwide.

Eylea 是全球视网膜眼病治疗领域的市场领导者，使用抗血管内皮生长因子（抗 VEGF），全球范围内应用超过 8800 万次，累积患者使用时间超过 1200 万年。

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。再生元在美国拥有 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 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.

新生血管性（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，可能在几个月内导致视力丧失。nAMD是全球不可逆失明和视力损害的主要原因之一。随着年龄增长，nAMD可能影响人们。它发生在异常血管生长并渗漏液体至黄斑下方时，黄斑是眼睛负责清晰中央视力和精细细节的部分。

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..

这种液体可能会损伤并使黄斑留下疤痕，从而导致视力丧失。全球有 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 患者会发展为晚期形式的 nAMD。

Diabetic macular edema (DME) is a common complication in the 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) 是糖尿病患者眼部常见的并发症。DME 发生在高血糖水平导致眼部血管受损并将液体渗漏到黄斑时。这可能导致视力丧失，甚至在某些情况下引发失明。在全球范围内，目前有 1.46 亿人患有糖尿病性视网膜病变 (DR)，而这种疾病可能发展为更为严重的情况，即糖尿病性黄斑水肿。

DME affects around 27 million people globally..

DME在全球范围内影响约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，集团拥有约93,000名员工，销售额达466亿欧元。