The European Medicines Agency (EMA) has approved the pre-filled syringe for the administration of Eylea™ 8 mg (114.3 mg/ml solution for injection) in the European Union. The new pre-filled syringe OcuClick™ will provide ophthalmologists with an efficient and simple way to accurately deliver the 70-microliter dose of Eylea 8 mg for the approved indications of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). Germany will be one of the first markets where the pre-filled syringe is launched.

欧洲药品管理局 (EMA) 已批准在欧盟使用预充式注射器来注射 Eylea ™ 8 mg（114.3 mg/ml 注射液）。新型预充式注射器 OcuClick ™将为眼科医生提供一种高效而简单的方法，以准确输送 70 微升剂量的 Eylea 8 mg，用于获批的新生血管性（湿性）年龄相关性黄斑变性 (nAMD) 和糖尿病性黄斑水肿 (DME) 适应症。德国将成为首批推出预充式注射器的市场之一。

“We are thrilled about the introduction of the pre-filled syringe for Eylea 8 mg, as it represents a significant advancement in administering an eye injection. This simple, easy, and accurate application method will greatly benefit ophthalmologists and patients, allowing for fast and precise treatment,” said University Professor Dr. med Oliver Zeitz, Senior Consultant and Site Manager of the Department of Ophthalmology at the Charité Campus Benjamin Franklin, Berlin, Germany.

德国柏林本杰明富兰克林夏里特大学眼科系高级顾问兼现场经理、医学教授奥利弗·蔡茨博士表示：“我们很高兴推出用于 Eylea 8 毫克的预充式注射器，因为它代表了眼部注射的重大进步。这种简单、轻松且准确的给药方法将极大地造福眼科医生和患者，实现快速而精准的治疗。”

“As a leader in ophthalmology we relentlessly strive for customer-oriented solutions,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer. “OcuClick offers the doctor excellent control, precision, and simplicity for the administration of Eylea 8 mg. This innovative ophthalmic syringe, combined with the Eylea 8 mg solution approved for extended treatment intervals of up to five months in appropriate patients, shows how our innovation can directly benefit patients.”

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 Christine Roth 表示：“作为眼科领域的领导者，我们不懈地追求以客户为导向的解决方案。OcuClick 为医生提供了出色的控制、精确度和简便性，可轻松给药 8 毫克 Eylea。这款创新的眼科注射器与获准在合适的患者中将治疗间隔延长至五个月的 8 毫克 Eylea 溶液相结合，展示了我们的创新如何直接造福患者。”

Eylea 8 mg has been developed to reduce the disease burden and to extend treatment intervals with comparable efficacy and safety to standard of care Eylea 2 mg. The successful pivotal clinical trials PULSAR and PHOTON led to the approval in nAMD and DME in the European Union with the unprecedented labelling that allows for extended treatment intervals of up to five months in appropriate patients. Eylea 8 mg met its primary endpoint in PULSAR and PHOTON demonstrating non-inferior best-corrected visual acuity at extended intervals of 12- and 16 weeks compared to Eylea 2 mg at a fixed 8-week interval.

Eylea 8 mg 的开发旨在减轻疾病负担并延长治疗间隔，其疗效和安全性与标准治疗 Eylea 2 mg 相当。PULSAR 和 PHOTON 关键临床试验的成功推动了欧盟批准其用于治疗 nAMD 和 DME，并获得了前所未有的标签，允许在合适的患者中将治疗间隔延长至五个月。Eylea 8 mg 在 PULSAR 和 PHOTON 中达到了其主要终点，与固定 8 周间隔的 Eylea 2 mg 相比，在 12 周和 16 周的延长间隔内表现出不劣于最佳矫正视力。

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 following any regulatory approvals.

Eylea 8 mg（阿柏西普 8 mg；在美国：Eylea HD）由拜耳和 Regeneron 联合开发。Regeneron 在美国拥有 Eylea 2 mg（阿柏西普 2 mg）和 Eylea HD 的独家权利。拜耳已获得美国以外的独家营销权，在获得任何监管部门批准后，两家公司将平等分享 Eylea 2 mg 和 Eylea 8 mg 的销售利润。