After storming the market with its longer-acting macular degeneration shot Vabysmo, Roche is laying the groundwork to expand the reach of its other eye disease innovation—refillable implant Susvimo.

在用长效黄斑变性疫苗Vabysmo冲击市场后，罗氏正在为扩大其其他眼病创新可再填充植入物Susvimo的范围奠定基础。

On Thursday, Roche not only announced that the FDA has accepted its application for Susvimo to treat diabetic retinopathy (DR) and diabetic macular edema (DME), the company also unveiled results that demonstrate Susvimo’s durability against both disorders.

周四，罗氏不仅宣布FDA已接受Susvimo治疗糖尿病视网膜病变（DR）和糖尿病性黄斑水肿（DME）的申请，该公司还公布了证明Susvimo对这两种疾病的持久性的结果。

Data from the phase 3 Pavilion (DR) and Pagoda (DME) studies show that Susvimo sustained its efficacy for two years while maintaining its safety profile. Roche’s subsidiary Genentech shared the results Thursday at the American Society of retina Specialists (ASRS) annual meeting in Stockholm, Sweden..

来自第三阶段展馆（DR）和宝塔（DME）研究的数据表明，Susvimo在保持其安全性的同时，持续了两年的疗效。罗氏的子公司基因泰克周四在瑞典斯德哥尔摩举行的美国视网膜专家学会（ASRS）年会上分享了这一结果。。

On Wednesday at the ASRS, Genentech also presented results from a Vabysmo study, which showed that after four years of treatment more than 90% of patients had no sign of DME and that nearly 80% were able to extend their dosing intervals to every three to four months.

周三在ASRS上，Genentech还介绍了Vabysmo研究的结果，该研究表明，经过四年的治疗，超过90%的患者没有DME的迹象，近80%的患者能够将给药间隔延长至每三到四个月一次。

Vabysmo, which was approved in 2022 to treat wet-age-related macular edema (AMD) and DME, entered the market as a longer-acting competition to Regeneron and Bayer’s Eylea. The original Eylea has a staying power of two months until the companies answered in August 2023 with a high-dose version that can be given up to once every four months. .

Vabysmo于2022年被批准用于治疗湿性年龄相关性黄斑水肿（AMD）和DME，作为与Regeneron和拜耳Eylea的长期竞争进入市场。最初的Eylea有两个月的持久力，直到2023年8月，这些公司以高剂量版本作出回应，最多每四个月服用一次。。

As for Susvimo, the unique product appears back on track. It was initially approved for AMD in October 2021 but was recalled by the company a year later because of a manufacturing issue. Earlier this month, Roche said that the FDA had signed off on its re-launch.

。它最初于2021年10月被批准用于AMD，但一年后由于制造问题被该公司召回。本月早些时候，罗氏公司表示，美国食品和药物管理局（FDA）已经签署了重新推出的协议。

In the long-term results of the Pavilion study, DR patients—who were refilled with Susvimo every nine months through a span of two years—maintained the progress they showed during their first year of treatment. Additionally, 80% of patients achieved a two-step or greater improvement in the 12-step diabetic retinopathy severity scale (DRSS), the primary tool used to measure the progression of the disorder..

在Pavilion研究的长期结果中，在两年的时间里，每九个月补充一次Susvimo的DR患者保持了治疗第一年的进展。此外，80%的患者在12步糖尿病视网膜病变严重程度量表（DRSS）中取得了两步或更大的改善，DRSS是用于测量疾病进展的主要工具。。

In the long-term results of the Pagoda study, DME patients—who received refills of Susvimo every six months for a span of two years—continued to maintain the improvements seen in their vision through one year, which equated to gaining two more lines on an eye chart. Additionally, 95% of those on Susvimo did not need additional treatment with supplemental injections..

在PODAGO研究的长期结果中，在两年的时间内，每六个月接受一次Susvimo补充的DME患者在一年内继续保持视力改善，这相当于在眼图上多获得两条线。。。

Related

相关

Roche to reintroduce eye implant med Susvimo 2 years after recall

召回2年后，罗氏将重新引入med Susvimo眼科植入物

“These efficacy and safety results demonstrate that Susvimo can deliver robust vision outcomes over two years for people with diabetic eye diseases that can cause vision loss,” Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of global product development, said in a release. “If approved by the FDA, Susvimo could bring a new treatment paradigm for diabetic eye diseases.”.

Genentech首席医疗官兼全球产品开发负责人Levi Garraway医学博士在一份新闻稿中表示：“这些疗效和安全性结果表明，Susvimo可以在两年内为糖尿病眼病患者提供强大的视力结果，这些疾病可能会导致视力丧失。”。“如果获得FDA的批准，Susvimo可能会为糖尿病眼病带来一种新的治疗模式。”。

A large market awaits if Susvimo can earn its label expansion. In the United States, there are 7.7 million with DR. The disorder can progress into DME, which affects 750,000 in the U.S.

如果Susvimo能够赢得其品牌扩张，一个巨大的市场正在等待。在美国，有770万人患有DR。这种疾病可以发展为DME，在美国影响750000人。

The FDA-accepted application was based on the one-year results of the Pavilion and Pagoda studies.

FDA接受的申请是基于展馆和宝塔研究的一年结果。

Related

相关

Roche's soaring Vabysmo sales raise the stakes in ophthalmology face-off with Regeneron's Eylea: analyst

罗氏（Roche）瓦比斯莫（Vabysmo）销售额飙升，增加了眼科与Regeneron公司（Regeneron's Eylea）对峙的风险：分析师

While uptake of Susvimo was slow during its initial launch, the same can’t be said of Vabysmo, which generated sales of 847 million Swiss francs ($933 million) in the first quarter for a 108% year-over-year increase. Meanwhile, Regeneron tallied worldwide sales of Eylea at $2.25 billion, which was a 1% decline from the first quarter of 2023.

。与此同时，Regeneron统计Eylea的全球销售额为22.5亿美元，比2023年第一季度下降了1%。

.

.

Earlier this month, the FDA gave a thumbs up for Vabysmo to be provided in a prefilled syringe. The nod gives doctors a more convenient, ready-to-use alternative to drawing the medicine from a vial.

本月早些时候，美国食品和药物管理局（FDA）表示赞成将Vabysmo装在预充式注射器中。这种点头给医生提供了一种比从小瓶中提取药物更方便、随时可用的替代方法。