Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Susvimo®

罗氏集团（SIX:RO，ROG；OTCQX:RHHBY）的成员Genentech今天宣布，美国食品和药物管理局（FDA）已批准Susvimo®

(ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes, affecting more than 29 million adults worldwide. Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections.

（雷珠单抗注射液）100 mg/mL用于治疗糖尿病性黄斑水肿（DME），这是糖尿病成年人视力丧失的主要原因，影响全球2900多万成年人。Susvimo是FDA批准的第一种也是唯一一种能够维持DME患者视力的治疗方法，其治疗方法少于标准护理眼注射。

Susvimo is now available to U.S. retina specialists and their patients with DME..

Susvimo现在可供美国视网膜专家及其DME患者使用。。

“Susvimo presents a unique, convenient treatment alternative to routine eye injections for people with a potentially blinding diabetic eye condition,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “As the global prevalence of this condition continues to grow, today's FDA approval for Susvimo reflects our dedication to innovation and enhancing the patient experience.”.

医学博士、首席医疗官兼全球产品开发负责人Levi Garraway说：“Susvimo为患有潜在致盲性糖尿病眼病的人提供了一种独特、方便的常规眼部注射替代疗法。”。。

“I am excited to offer Susvimo to my patients living with diabetic macular edema who want an option with longer intervals between treatments due to their busy personal and professional lives,” said vitreoretinal surgeon, Jordan Graff, M.D., Barnet Dulaney Perkins Eye Center, Arizona. “Having completed dozens of Susvimo surgeries in my patients with wet, or neovascular, age-related macular degeneration, I’ve seen firsthand how Susvimo, with its continuous delivery of medication, can help preserve vision with fewer treatments.

亚利桑那州巴内特·杜拉尼·珀金斯眼科中心玻璃体视网膜外科医生乔丹·格拉夫（Jordan Graff，M.D.）说：“我很高兴为患有糖尿病性黄斑水肿的患者提供Susvimo，这些患者由于个人生活和职业生活繁忙，希望治疗间隔更长。”。“在我的湿性或新生血管性年龄相关性黄斑变性患者中完成了数十次Susvimo手术后，我亲眼目睹了Susvimo如何通过持续的药物治疗，以较少的治疗来帮助保持视力。

I look forward to broadening Susvimo’s impact to even more patients in my clinic.”.

我期待着将Susvimo的影响扩大到我诊所的更多患者。”。

The FDA decision was based on positive one-year results from the Phase III Pagoda study, which showed that Susvimo demonstrated sustained vision improvements in people with DME, with safety consistent with the known safety profile for Susvimo. In Pagoda, people with DME who received Susvimo refilled every six months achieved non-inferior improvements in vision compared with those receiving monthly 0.5 mg ranibizumab intravitreal injections (9.6 eye chart letters, similar to gaining two more lines on an eye chart, compared to 9.4 letters, respectively)..

FDA的决定是基于第三阶段Pagoda研究的一年积极结果，该研究表明Susvimo在DME患者中表现出持续的视力改善，其安全性与Susvimo的已知安全性一致。在宝塔，与每月接受0.5 mg雷珠单抗玻璃体内注射的患者相比，每六个月接受Susvimo补充的DME患者的视力改善不逊色（9.6个眼图字母，类似于在眼图上多获得两行，而分别为9.4个字母）。。

Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month. Susvimo was first approved by the FDA for the treatment of wet, or neovascular age-related macular degeneration (AMD) in 2021..

Susvimo通过Port递送平台连续递送定制的雷珠单抗制剂，而其他目前批准的治疗可能需要每月一次眼部注射。2021年，Susvimo首次被FDA批准用于治疗湿性或新生血管性年龄相关性黄斑变性（AMD）。。

Genentech is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions.

Genentech致力于帮助人们获得处方药，并将为处方药Susvimo的人提供全面服务，以帮助最大程度地减少获取和报销的障碍。患者可以致电833-EYE-GENE了解更多信息。。

About Diabetic Macular Edema (DME)

关于糖尿病性黄斑水肿（DME）

Affecting approximately 750,000 people in the U.S. and 29 million people globally, diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated. DME occurs when damaged blood vessels in the retina leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving.

糖尿病性黄斑水肿（DME）影响美国约75万人和全球2900万人，是一种威胁视力的视网膜疾病，如果不及时治疗，会导致失明和生活质量下降。当受损的视网膜血管渗入黄斑并引起黄斑肿胀时，就会发生DME。黄斑是视网膜的中心区域，负责阅读和驾驶所需的敏锐视力。

The number of people with DME is expected to grow as the prevalence of diabetes increases..

随着糖尿病患病率的增加，DME患者的数量预计会增加。。

About the Pagoda Study

关于宝塔研究

NCT04108156

时间04108156

) is a multicenter, randomized, active treatment-controlled, non-inferiority U.S.-based Phase III study evaluating the efficacy, safety and pharmacokinetics of Susvimo

)是一项多中心，随机，主动治疗控制，非劣效性的美国III期研究，评估Susvimo的疗效，安全性和药代动力学

(ranibizumab injection) 100 mg/mL refilled every six months compared with monthly ranibizumab 0.5 mg intravitreal injections, in 634 people with diabetic macular edema. Participants were randomized 3:2 to receive either Susvimo refilled every six months or continued monthly intravitreal ranibizumab injections.

（雷珠单抗注射液）在634名糖尿病黄斑水肿患者中，每六个月补充100毫克/毫升，而每月玻璃体内注射雷珠单抗0.5毫克。参与者以3:2的比例随机接受Susvimo每六个月补充一次或每月继续玻璃体内注射雷珠单抗。

In the Susvimo arm, participants received four loading doses of intravitreal ranibizumab before Susvimo implantation at week 16. The primary endpoint of the study is a change in best-corrected visual acuity score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at the average of week 60 and week 64.

在Susvimo组中，参与者在第16周植入Susvimo之前接受了四次负荷剂量的玻璃体内雷珠单抗。这项研究的主要终点是在平均第60周和第64周时，最佳矫正视力得分（一个人在阅读视力表上的字母时可以达到的最佳远视，包括戴眼镜等矫正视力）与基线的变化。

Following primary analysis, participants who were initially randomized to intravitreal injections received Susvimo, with refills every 24 weeks..

经过初步分析，最初随机接受玻璃体内注射的参与者接受了Susvimo，每24周补充一次。。

About Susvimo

关于Susvimo

Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is a refillable implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customized formulation of ranibizumab over time. Susvimo is indicated for intravitreal use via the Susvimo eye implant only.

Susvimo（雷珠单抗注射液）通过眼部植入物进行玻璃体内使用的100 mg/mL是一种可重复填充的植入物，在一次性门诊手术中通过手术插入眼睛。随着时间的推移，Susvimo不断提供雷珠单抗的定制配方。。

Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels. Susvimo was previously called the Port Delivery System with ranibizumab in the U.S..

雷珠单抗是一种血管内皮生长因子（VEGF）抑制剂，旨在结合并抑制VEGF-a，VEGF-a是一种已被证明在新血管形成和血管渗漏中起关键作用的蛋白质。Susvimo之前在美国被称为ranibizumab的港口输送系统。。

The customized formulation of ranibizumab delivered by Susvimo is different from the ranibizumab intravitreal injection, a medicine marketed as Lucentis

Susvimo提供的雷珠单抗的定制配方不同于雷珠单抗玻璃体内注射，雷珠单抗玻璃体内注射是一种以Lucentis销售的药物

(ranibizumab injection), which is approved to treat wet, or neovascular, age-related macular degeneration (AMD) and other retinal diseases. Lucentis was first approved for wet AMD by the FDA in 2006. Genentech is also developing DutaFabs – the next generation of bispecific antibodies designed for increased efficacy and durability – tailored for continuous delivery via the Port Delivery implant..

（雷珠单抗注射液），被批准用于治疗湿性或新生血管性年龄相关性黄斑变性（AMD）和其他视网膜疾病。Lucentis于2006年首次被FDA批准用于湿性AMD。基因泰克（Genentech）还正在开发DutaFabs，这是下一代双特异性抗体，旨在提高疗效和耐用性，可通过港口输送植入物进行连续输送。。

Susvimo Indication

Susvimo指示

SUSVIMO (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) and diabetic macular edema (DME) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor inhibitor medication..

SUSVIMO（雷珠单抗注射液）100 mg/mL用于通过眼部植入物进行玻璃体内使用，用于治疗新生血管（湿）年龄相关性黄斑变性（AMD）和糖尿病性黄斑水肿（DME）患者，这些患者先前至少对两次玻璃体内注射血管内皮生长因子抑制剂药物有反应。。

About Lucentis®

关于Lucentis®

Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.

Lucentis是一种血管内皮生长因子（VEGF）抑制剂，旨在结合并抑制VEGF-a，VEGF-a是一种被认为在新血管形成（血管生成）和血管通透性过高（渗漏）中起关键作用的蛋白质。

Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV).

Lucentis被FDA批准用于治疗湿性年龄相关性黄斑变性（AMD），视网膜静脉阻塞（RVO）后黄斑水肿，糖尿病性黄斑水肿（DME），糖尿病性视网膜病变（DR）和近视脉络膜新生血管（mCNV）患者。

Lucentis was developed by Genentech, a member of the Roche Group. The company retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world.

Lucentis由罗氏集团（Roche Group）成员基因泰克（Genentech）开发。该公司在美国拥有商业权利，诺华在世界其他地区拥有独家商业权利。

Outside the United States, Lucentis is approved in more than 120 countries to treat adult patients with wet AMD, and for the treatment of visual impairment due to DME, due to macular edema secondary to both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), and due to choroidal neovascularization (CNV)..

在美国以外的120多个国家，Lucentis被批准用于治疗成人湿性AMD患者，以及治疗DME引起的视力障碍，视网膜分支静脉阻塞（BRVO）和视网膜中央静脉阻塞（CRVO）继发的黄斑水肿，以及脉络膜新生血管（CNV）。