Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., USA, today announced the initiation of the Phase 2b/3 BRUNELLO trial evaluating Restoret™ (MK-3000, formerly EYE103) for the treatment of diabetic macular edema (DME)..

默克（纽约证券交易所代码：MRK），在美国和加拿大以外被称为MSD，以及默克公司（Merck＆Co.，Inc.，Rahway，N.J.，USA）的全资子公司EyeBio，今天宣布启动2b/3期BRUNELLO试验，评估Restoret™（MK-3000，前EYE103）治疗糖尿病性黄斑水肿（DME）。。

MK-3000 is an investigational, potentially first-in-class tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway. The initiation of the BRUNELLO trial is based on results from the open-label, Phase 1/2 AMARONE study of MK-3000 in patients with DME and neovascular age-related macular degeneration (NVAMD)..

MK-3000是一种研究性的，可能是一流的四价三特异性抗体，可作为无翼相关整合位点（Wnt）信号通路的激动剂。BRUNELLO试验的启动是基于MK-3000在DME和新生血管性年龄相关性黄斑变性（NVAMD）患者中的开放标签1/2期AMARONE研究的结果。。

“Data from the Phase 1/2 AMARONE study provided early evidence for the potential of MK-3000 for patients with retinal disease,” said Dr. David Guyer, founder, chief executive officer and president of EyeBio. “The initiation of the BRUNELLO trial marks an important milestone as we work with our new colleagues at Merck, driven by the common purpose to deliver new, much needed options for patients with diabetic macular edema.”.

“来自1/2期AMARONE研究的数据为MK-3000对视网膜疾病患者的潜力提供了早期证据，”EyeBio创始人、首席执行官兼总裁David Guyer博士说。“BRUNELLO试验的启动标志着一个重要的里程碑，因为我们与默克公司的新同事合作，共同目标是为糖尿病性黄斑水肿患者提供新的，急需的选择。”。

About the BRUNELLO trial

关于BRUNELLO 试验

BRUNELLO is a randomized, double masked Phase 2b/3 trial ( NCT06571045 ) evaluating the efficacy and safety of two dose levels of intravitreal (IVT) Restoret (MK-3000) versus active control ranibizumab in patients with DME. Eligible patients will be randomized 1:1:1 to receive low and high dose regimens of MK-3000 or ranibizumab every four weeks for the first year. In the second year, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm. The dual primary endpoints are safety and mean change in best-corrected visual acuity (BCVA) from baseline to week 52 in the study eye of the participants, using standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) vision

BRUNELLO 是一项随机、双盲 2b/3 期试验 ( NCT06571045 )，旨在评估两种剂量水平的玻璃体内注射 (IVT) Restoret (MK-3000) 与阳性对照雷珠单抗对 DME 患者的疗效和安全性。符合条件的患者将以 1:1:1 的比例随机分配，在第一年每四周接受低剂量和高剂量的 MK-3000 或雷珠单抗治疗。在第二年，参与者的治疗频率将根据个性化治疗间隔 (PTI) 算法而变化。两个主要终点是安全性和参与者研究眼从基线到第 52 周的最佳矫正视力 (BCVA) 平均变化，使用标准化早期糖尿病视网膜病变治疗研究 (ETDRS) 视力。

About diabetic macular edema

关于糖尿病性黄斑水肿

Diabetic macular edema (DME) is a serious retinal condition that poses a risk to vision, potentially leading to blindness and a reduced quality of life if left untreated. DME impacts an estimated 750,000 people in the United States and occurs when damaged blood vessels leak into the retina, resulting in swelling in the macula, the central region of the retina crucial for precise vision necessary for everyday activities.

糖尿病性黄斑水肿（DME）是一种严重的视网膜疾病，对视力构成风险，如果不及时治疗，可能导致失明和生活质量下降。DME在美国影响了大约75万人，当受损的血管渗入视网膜，导致黄斑肿胀时就会发生DME，黄斑是视网膜的中心区域，对于日常活动所需的精确视力至关重要。

The prevalence of DME is anticipated to rise with the increasing incidence of diabetes..

预计DME的患病率将随着糖尿病发病率的增加而上升。。

About Restoret

关于Restoret

Restoret (MK-3000, formerly EYE103) is an investigational, potentially first-in-class tetravalent, tri-specific Wnt antibody designed to address unmet medical need in patients with retinal diseases, including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD).

Restoret（MK-3000，原名EYE103）是一种研究性的，可能是一流的四价三特异性Wnt抗体，旨在解决视网膜疾病患者未满足的医疗需求，包括糖尿病性黄斑水肿（DME）和新生血管性年龄相关性黄斑变性（NVAMD）。

MK-3000 is administered as an intravitreal injection seeking to eliminate vascular leakage in retinal diseases by agonizing the Wnt pathway with the goal of restoring and maintaining the blood-retinal barrier. Preclinical evidence indicates that agonizing the Wnt pathway in the retina may reduce vascular leakage..

MK-3000 是一种玻璃体内注射剂，通过激动 Wnt 通路来消除视网膜疾病中的血管渗漏，从而达到恢复和维持视网膜血屏障的目的。临床前证据表明，激动视网膜中的 Wnt 通路可减少血管渗漏。

About Merck

默克

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.

在美国和加拿大以外被称为MSD的默克公司，我们的目标是团结一致的：我们利用尖端科学的力量来拯救和改善世界各地的生活。130多年来，我们通过开发重要的药物和疫苗给人类带来了希望。

We aspire to be the premier research-intensive biopharmaceutical company in the world - and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

我们立志成为世界上领先的研究密集型生物制药公司-今天，我们处于研究的前沿，以提供创新的健康解决方案，促进人类和动物疾病的预防和治疗。我们培养了一支多元化和包容性的全球劳动力队伍，并每天负责任地运作，为所有人和社区创造一个安全、可持续和健康的未来。