TOKYO, Feb. 6, 2024 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced the enrollment of the first patient in a Phase 2 clinical trial, multi-center, randomized, double-masked, parallel group study of tivozanib eye drops (KHK4951). This study investigates the efficacy and safety of KHK4951 in patients with diabetic macular edema (DME).

东京，2024年2月6日/PRNewswire/--Kyowa Kirin Co.，Ltd.（东京证交所：4151）今天宣布，第一名患者参加了tivozanib滴眼液（KHK4951）的2期临床试验，多中心，随机，双盲，平行组研究。本研究调查了KHK4951治疗糖尿病性黄斑水肿（DME）患者的疗效和安全性。

Tivozanib, the active ingredient of KHK4951 is a small-molecule vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 tyrosine kinase inhibitor (TKI) discovered and developed by Kyowa Kirin. KHK4951 is a novel nano-crystalized tivozanib eye drops designed to deliver it efficiently to the posterior ocular tissues and is being developed as a potential treatment option for neovascular (wet) age-related macular degeneration (nAMD) and DME.

Tivozanib是KHK4951的活性成分，是由Kyowa Kirin发现和开发的小分子血管内皮生长因子受体（VEGFR）-1，-2和-3酪氨酸激酶抑制剂（TKI）。KHK4951是一种新型纳米结晶的替沃扎尼滴眼液，旨在将其有效地输送到后眼组织，目前正在开发作为新生血管（湿性）年龄相关性黄斑变性（nAMD）和DME的潜在治疗选择。

An oral formulation of tivozanib is currently marketed as FOTIVDAⓇ in the U.S. by AVEO Oncology, an LG Chem Company, and in Europe by EUSA Pharma (UK) Ltd. for another indication..

tivozanib的口服制剂目前在美国由LG化学公司AVEO Oncology以FOTIVDAⓇ的形式销售，在欧洲由EUSA Pharma（UK）Ltd.以另一种适应症销售。。

The Phase 2 study will be recruiting 150 patients with DME across the US, Japan, Australia and South Korea.  The primary outcome measure is reduction of 15 or more letters from baseline in BCVA (Best Corrected Visual Acuity) as measured by the ETDRS visual acuity chart.

第二阶段研究将在美国、日本、澳大利亚和韩国招募150名DME患者。主要结局指标是通过ETDRS视力表测量的BCVA（最佳矫正视力）从基线减少15个或更多字母。

'Tivozanib eye drops have the potential to provide a novel non-invasive treatment option for patients with DME', said Takeyoshi Yamashita, Ph.D., Director of the Board, chief medical officer, and senior managing executive officer of Kyowa Kirin. 'The current standard of care is intravitreal injection drugs, which causes various burdens for patients, caregivers and doctors.

Kyowa Kirin董事会董事、首席医疗官和高级管理执行官山下武（TakeyoshiYamashita）博士说：“替沃扎尼滴眼液有可能为DME患者提供一种新型的非侵入性治疗选择。”目前的护理标准是玻璃体内注射药物，这给患者，护理人员和医生带来了各种负担。

We believe KHK4951 has the potential to address patient needs and preferences for a less invasive mode of administration.'.

我们相信KHK4951有可能解决患者的需求和偏好，采用侵入性较小的给药方式。”。

A separate Phase 2 study to evaluate KHK4951 in patients with neovascular(wet) age-related macular degeneration(nAMD) is also being initiated. This study is currently recruiting patients.

另一项评估新生血管（湿性）年龄相关性黄斑变性（nAMD）患者KHK4951的2期研究也正在启动。这项研究目前正在招募患者。

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

协和麒麟集团公司致力于通过追求生命科学和技术的进步创造新的价值，为全世界人民的健康和福祉做出贡献。

About diabetic macular edema (DME)

关于糖尿病性黄斑水肿（DME）

DME remains the most common cause of vision loss among working-age patients with diabetes mellitus and affects about 1.3 million people in the US. DME can occur at any stage of diabetic retinopathy. It is manifested as retinal thickening and swelling of the macula caused by the accumulation of intraretinal fluid, primarily in the inner and outer plexiform layers, and is believed to be a result of leakage of the retinal vasculature..

DME仍然是工作年龄糖尿病患者视力丧失的最常见原因，影响美国约130万人。DME可发生在糖尿病视网膜病变的任何阶段。它表现为视网膜内液体积聚引起的黄斑部视网膜增厚和肿胀，主要是在内部和外部丛状层，并被认为是视网膜脉管系统渗漏的结果。。

At present, the treatment choices for DME are all invasive pharmacologic therapies are intravitreal anti-VEGF or corticosteroid injections, and surgical therapies are laser photocoagulation or vitrectomy.

目前，DME的治疗选择都是侵入性药物治疗，即玻璃体内抗VEGF或皮质类固醇注射，手术治疗是激光光凝或玻璃体切除术。

About Kyowa Kirin

关于协和麒麟

Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by a severe or rare disease.

协和麒麟旨在发现具有改变生命价值的新药。作为一家总部位于日本的全球专业制药公司，我们在药物发现和生物技术创新方面投资了70多年，目前正在致力于设计下一代抗体以及细胞和基因疗法，以帮助受严重或罕见疾病影响的患者。

A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions – Japan, Asia Pacific, North America, and EMEA/International. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com..

共同致力于我们的价值观、可持续发展和让人们微笑，这使我们在日本、亚太地区、北美和欧洲、中东和非洲/国际四个地区团结在一起。您可以通过以下网址了解更多关于协和麒麟业务的信息：https://www.kyowakirin.com..

SOURCE Kyowa Kirin

来源：协和麒麟