MSD's return to the ophthalmology field after decades of absence, via the acquisition of EyeBio in a $3 billion deal in 2024, has been charged up with a positive phase 3 trial in diabetic macular oedema (DME).

默沙东在缺席数十年后，通过2024年以30亿美元收购EyeBio重返眼科领域，并凭借一项针对糖尿病性黄斑水肿（DME）的阳性III期临床试验而势头强劲。

The phase 2b/3 BRUNELLO study of remigromig (MK-3000, formerly known as EYE103) showed that two doses of the Wnt pathway-targeting trispecific antibody were both at least as effective as the active control, the VEGF inhibitor ranibizumab, in maintaining vision at 52 weeks in adult

雷米格米（MK-3000，前称EYE103）的2b/3期BRUNELLO研究表明，在成人患者中，两种剂量的靶向Wnt信号通路的三特异性抗体在52周时维持视力的效果均不劣于活性对照药——VEGF抑制剂雷珠单抗。

DME

二甲醚

patients.

患者。

Remigromig introduces the first entirely new mechanism of action for retinal vascular diseases in over two decades, and is thought to work by maintaining the blood-retinal-barrier and preventing the leakage of retinal fluid that is seen in DME, as well as other diseases like neovascular age-related macular degeneration (AMD)..

Remigromig 引入了二十多年来首个针对视网膜血管疾病的全新作用机制，据信其通过维持血-视网膜屏障并防止糖尿病性黄斑水肿（DME）以及其他疾病（如新生血管性年龄相关性黄斑变性 [AMD]）中常见的视网膜液体渗漏而发挥作用。

That leakage often persists despite treatment with VEGF inhibitors like ranibizumab, and the hope is that remigromig could find a role as an alternative or addition to these drugs, assuming it continues to show efficacy and safety in future trial readouts.

尽管使用雷珠单抗等VEGF抑制剂进行治疗，这种渗漏现象往往仍然存在。人们希望，如果remigromig在未来的试验结果中继续显示出疗效和安全性，它或许能作为这些药物的替代或补充疗法发挥作用。

'Despite available therapies, up to 40% of patients with [DME] do not fully respond and remain at risk of continued vision loss,' said Dr David Guyer, chief executive officer of EyeBio, which operates as a wholly-owned subsidiary of MSD.

“尽管已有可用的治疗方法，但高达40%的[DME]患者未能完全响应，并仍面临持续视力丧失的风险，”EyeBio首席执行官David Guyer博士表示。EyeBio是默沙东（MSD）的全资子公司。

Safety signal?

安全信号？

One potential fly in the ointment for MSD was that remigromig was associated with higher rates of proliferative diabetic retinopathy (PDR) – a severe stage of diabetic eye disease where abnormal new blood vessels grow on the surface of the retina – as well as vitreous haemorrhage and treatment discontinuations due to adverse events compared to ranibizumab..

对默沙东而言，一个潜在的不利因素是，与雷珠单抗相比，remigromig 与更高的增殖性糖尿病视网膜病变（PDR）发生率相关——这是糖尿病眼病的一个严重阶段，其特征是视网膜表面生长出异常的新生血管——同时也与更高的玻璃体出血发生率以及因不良事件导致的治疗中断率相关。

Those could be related to the drug's mechanism, as unlike VEGF inhibition it does not block the formation of new blood vessels, so the higher rates could be a manifestation of the natural progression of the disease rather than a side effect of the drug. Nevertheless, safety looks likely to be scrutinised when the full results from BRUNELLO are released in full at the American Academy of Ophthalmology (AAO) congress next month, and in future trial readouts..

这些可能与该药物的作用机制有关，因为与VEGF抑制不同，它并不阻断新生血管的形成，因此较高的发生率可能是疾病自然进展的表现，而非药物的副作用。尽管如此，在下个月美国眼科学会（AAO）大会上全面公布BRUNELLO研究的完整结果时，以及在未来的试验数据读出中，安全性问题可能会受到严格审查。

MSD is running a second phase 2b/3 trial of the Wnt drug in DME, called BAROLO, which is due to read out next year, as well as a mid-stage study (SUPER TUSCAN) in neovascular AMD and retinal vein occlusion (RVO).

默沙东正在开展其Wnt通路药物针对糖尿病性黄斑水肿（DME）的第二项2b/3期临床试验（名为BAROLO），该试验预计将于明年公布结果；同时，该公司也在进行一项针对新生血管性年龄相关性黄斑变性（nAMD）和视网膜静脉阻塞（RVO）的中期临床研究（名为SUPER TUSCAN）。

At stake is a slice of the massive market for retinal vascular disease treatments, currently led by Bayer and Regeneron's

争夺的是视网膜血管疾病治疗这一庞大市场的一部分，目前该市场由拜耳和再生元主导

Eylea

艾力雅

(aflibercept) VEGF inhibitor range, which made almost $8 billion in global sales last year. Following after is Roche's VEGFxAng-2 bispecific antibody

（阿柏西普）VEGF抑制剂类别，去年全球销售额接近80亿美元。紧随其后的是罗氏的VEGF/Ang-2双特异性抗体

Vabysmo

法比司莫

(faricimab), which brought in around $5.2 billion.

（法瑞西单抗），其收入约为52亿美元。

Analysts said remigromig is a key component of MSD's strategic goal to achieve $70 billion in annual sales by the 2030s to offset the upcoming patent expiration of $32 billion cancer immunotherapy blockbuster Keytruda (pembrolizumab).

分析师表示，remigromig 是默沙东实现2030年代年销售额达700亿美元这一战略目标的关键组成部分，以抵消其年销售额达320亿美元的癌症免疫疗法重磅药物Keytruda（帕博利珠单抗）即将面临的专利到期影响。

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照片由

Andrei Castanha

安德烈·卡斯塔尼亚

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