Susvimo can help people with diabetic retinopathy (DR) maintain their vision and prevent progression to blindness with only one treatment every nine months

Susvimo可以帮助糖尿病视网膜病变（DR）患者保持视力，并通过每九个月一次的治疗预防失明的进展。

Susvimo’s innovative technology via the Port Delivery Platform may offer an alternative to regular eye injections in the US

Susvimo通过Port Delivery Platform的创新技术可能为美国常规的眼部注射提供一种替代方案。

Diabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which is also approved for treating wet, or neovascular, age-related macular degeneration and diabetic macular edema

糖尿病视网膜病变影响着美国近1000万人，是Susvimo获得FDA批准的第三个适应症，该药物还被批准用于治疗湿性（或新生血管性）年龄相关性黄斑变性和糖尿病性黄斑水肿。

South San Francisco, CA -- May 22, 2025 --

加利福尼亚州南旧金山 -- 2025年5月22日 --

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

基因泰克（Genentech），罗氏集团（SIX：RO，ROG；OTCQX：RHHBY）的成员，今天宣布美国食品药品监督管理局（FDA）已批准Susvimo。

®

®

(ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. and more than 100 million people globally. It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months.

（雷珠单抗注射液）100毫克/毫升，用于治疗糖尿病视网膜病变（DR），这是一种可能导致失明的疾病，影响着美国近1000万人和全球超过1亿人。这是首个也是唯一一个获得FDA批准的持续给药治疗方案，每九个月只需补充一次，即可帮助DR患者保持视力。

Susvimo is now available to U.S. retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections..

Susvimo现在可供美国的视网膜专科医生及其先前对至少两次抗血管内皮生长因子（VEGF）注射有反应的糖尿病视网膜病变（DR）患者使用。

“The approval of Susvimo for diabetic retinopathy expands treatment options for patients, offering predictable and immediate durability after implantation with only one treatment every nine months,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Many patients with common retinal conditions seek alternative treatment options like Susvimo that can help preserve vision with longer intervals between treatments than regular eye injections.” .

“Susvimo获批用于糖尿病视网膜病变，为患者扩展了治疗选择，植入后效果可预测且立竿见影，仅需每九个月接受一次治疗，”首席医学官兼全球产品开发主管Levi Garraway博士表示。“许多常见视网膜疾病的患者正在寻找像Susvimo这样的替代治疗方案，它能够在比常规眼内注射更长的治疗间隔内帮助保护视力。”

“Susvimo is a compelling new treatment for patients at risk of vision loss from progression of diabetic retinopathy,” said vitreoretinal surgeon, Carl Awh, M.D., Tennessee Retina, Tennessee. “I am delighted to have this far more durable treatment available for my patients.”

“Susvimo 是一种令人信服的新型治疗方法，适用于面临糖尿病视网膜病变进展导致视力丧失风险的患者，”田纳西州视网膜玻璃体视网膜外科医生 Carl Awh 医学博士表示，“我很高兴能为我的患者提供这种更持久的治疗选择。”

The FDA decision was based on positive one-year results from the Phase III Pavilion study. People with DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS). This means there was a reduction in the severity of eye damage caused by diabetes, compared with those under monthly clinical observation who were treated with anti-VEGF injections as needed based on disease progression.

FDA 的决定基于 III 期 Pavilion 研究的积极一年结果。接受每九个月补充一次 Susvimo 治疗的 DR 患者在糖尿病视网膜病变严重程度量表 (DRSS) 上取得了显著改善。这意味着，与根据疾病进展按需接受抗 VEGF 注射治疗且每月进行临床观察的患者相比，糖尿病引起的眼部损伤严重程度有所减轻。

Additionally, none of the participants receiving Susvimo required supplemental treatment at one year. Safety was consistent with the known safety profile for Susvimo..

此外，接受Susvimo治疗的参与者在一年内均无需补充治疗。安全性与Susvimo已知的安全性特征一致。

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. The Port Delivery Platform is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure, which introduces medicine directly into the eye, addressing certain retinal conditions that can cause vision loss..

Susvimo通过Port Delivery Platform平台持续输送定制配方的雷珠单抗，而其他目前已批准的治疗方法可能需要每月一次的眼部注射。Port Delivery Platform是一种可重复填充的眼部植入物，通过一次性门诊手术植入眼内，直接向眼中引入药物，以应对可能导致视力丧失的某些视网膜疾病。

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.

基因泰克致力于帮助人们获取处方药，并将为使用Susvimo的患者提供全面的服务，以尽量减少获取和报销的障碍。患者可以拨打833-EYE-GENE获取更多信息。对于符合条件的人，基因泰克通过Genentech Access Solutions提供患者援助计划。

More information is also available at (866) 4ACCESS/(866) 422-2377 or .

更多信息请拨打 (866) 4ACCESS/(866) 422-2377 或 。

https://www.Genentech-Access.com

https://www.Genentech-Access.com

.

。

Visit

访问

https://www.Susvimo.com

https://www.Susvimo.com

for additional information.

获取更多信息。

About Diabetic Retinopathy (DR)

关于糖尿病视网膜病变（DR）

Diabetic retinopathy (DR) affects almost 10 million people in the U.S. and more than 100 million people globally, accounting for almost 5% of all cases of blindness. DR can lead to the development of DME, which is a leading cause of vision loss, affecting around 29 million adults worldwide. The longer a person has diabetes, especially if it is poorly controlled, the higher the risk of developing diabetic retinopathy and vision loss.

糖尿病性视网膜病变（DR）影响着美国近1000万人，全球超过1亿人，占所有失明病例的近5%。DR可能导致糖尿病性黄斑水肿（DME）的发生，这是视力丧失的主要原因之一，影响着全球约2900万成年人。一个人患有糖尿病的时间越长，特别是如果控制不佳，发生糖尿病性视网膜病变和视力丧失的风险就越高。

Diabetic retinopathy occurs when blood vessels in the retina become damaged. This can cause vision loss or distortion when the abnormal vessels leak blood or fluid into the eye..

糖尿病性视网膜病变发生在视网膜中的血管受损时。当异常血管将血液或液体泄漏到眼睛中时，这可能导致视力丧失或扭曲。

About the Pavilion Study

关于展馆研究

Pavilion (

展馆 (

NCT04503551

NCT04503551

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

) 是一项多中心、随机、基于美国的 III 期研究，评估 Susvimo 的有效性、安全性和药代动力学。

®

®

(ranibizumab injection) 100 mg/mL refilled every nine months compared with people under monthly clinical observation, in 174 people with diabetic retinopathy without center-involved diabetic macular edema. Participants were randomized 5:3 to receive either Susvimo with refills every nine months or monthly clinical observation, respectively.

（雷珠单抗注射）100毫克/毫升，每九个月补充一次，与每月临床观察相比，针对174名无中心性糖尿病黄斑水肿的糖尿病视网膜病变患者。参与者以5:3的比例随机分配，分别接受每九个月补充一次的Susvimo或每月临床观察。

In the Susvimo arm, participants received two loading doses of intravitreal ranibizumab, before Susvimo implantation at week 4. The primary endpoint was the proportion of participants with at least a two-step improvement from baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at week 52.

在Susvimo组中，参与者在第4周接受Susvimo植入前接受了两剂玻璃体内雷珠单抗的负荷剂量。主要终点是第52周时在早期糖尿病视网膜病变治疗研究-糖尿病视网膜病变严重程度量表上，从基线至少提高两个等级的参与者比例。

Following the primary analysis, participants initially in the clinical observation arm received two ranibizumab loading doses before Susvimo implantation at week 64..

初步分析后，最初在临床观察组的参与者在第64周接受Susvimo植入前接受了两次雷珠单抗负荷剂量。

About Susvimo

关于Susvimo

®

®

(ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant

（雷珠单抗注射液）100毫克/毫升，用于通过眼内植入装置进行玻璃体内注射

Susvimo

苏斯维莫

®

®

(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.

（雷珠单抗注射液）100毫克/毫升，通过眼植入物用于玻璃体内注射，是一种可重复填充的植入物，通过一次性门诊手术植入眼中。Susvimo 会随着时间持续输送定制配方的雷珠单抗。Susvimo 仅适用于通过 Susvimo 眼植入物进行的玻璃体内使用。

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..

Ranibizumab 是一种血管内皮生长因子 (VEGF) 抑制剂，旨在结合并抑制 VEGF-A（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 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递送的雷珠单抗定制配方与作为Lucentis销售的雷珠单抗玻璃体内注射剂不同。

®

®

(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..

（雷珠单抗注射剂），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）及其他视网膜疾病。Lucentis于2006年首次获得FDA批准用于湿性AMD。基因泰克公司还在开发DutaFabs——下一代双特异性抗体，旨在提高疗效和持久性——专为通过Port Delivery植入物进行持续递送而设计。

Susvimo Indication

Susvimo 适应症

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), diabetic macular edema (DME), and diabetic retinopathy (DR) 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，通过眼内植入物用于玻璃体内注射，适用于治疗曾对至少两次血管内皮生长因子抑制剂药物注射产生反应的新生血管性（湿性）年龄相关性黄斑变性（AMD）、糖尿病性黄斑水肿（DME）和糖尿病性视网膜病变（DR）患者。

Susvimo Important Safety Information

Susvimo重要安全信息

WARNING: ENDOPHTHALMITIS

警告：眼内炎

The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab.

SUSVIMO 植入物与每月玻璃体内注射雷珠单抗相比，发生眼内炎的比率高达 3 倍。

Warnings and Precautions:

警告和注意事项：

The SUSVIMO implant and the procedures associated with inserting, filling, refilling, and (if medically necessary) removing the implant can cause other serious side effects, including:

SUSVIMO植入物及其相关的插入、填充、补充填充和（如有医学必要）移除植入物的程序可能会导致其他严重副作用，包括：

Who should not receive SUSVIMO?

谁不应该接受SUSVIMO？

Information for patients who are of childbearing potential

针对有生育潜力的患者的信息

Adverse Reactions

不良反应

The most common adverse reactions were blood on the white of the eye, redness in the white of the eye, sensitivity to light), and eye pain. These are not all the possible side effects of SUSVIMO.

最常见的不良反应为眼白出血、眼白发红、对光敏感和眼痛。这些并非 SUSVIMO 可能产生的全部副作用。

You may report side effects to the FDA at (800) FDA-1088 or

您可以拨打 (800) FDA-1088 向 FDA 报告副作用，或者

www.fda.gov/medwatch

www.fda.gov/medwatch

. You may also report side effects to Genentech at (888) 835-2555.

您也可以通过拨打(888) 835-2555向基因泰克报告副作用。

Please see additional Important Safety Information in the full SUSVIMO

请参阅完整的 SUSVIMO 中的其他重要安全信息

Prescribing Information

处方信息

, including

，包括

BOXED WARNING

黑框警告

or visit

或访问

https://www.Susvimo.com

https://www.Susvimo.com

.

。

About Lucentis

关于Lucentis

®

®

(ranibizumab injection)

（雷珠单抗注射液）

Lucentis

兰尼单抗

®

®

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.

是一种血管内皮生长因子（VEGF）抑制剂，旨在结合并抑制VEGF-A，这种蛋白被认为在新血管形成（血管生成）和血管高通透性（渗漏）中起关键作用。

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已获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）后的黄斑水肿、糖尿病性黄斑水肿（DME）、糖尿病性视网膜病变（DR）以及近视性脉络膜新生血管化（mCNV）的患者。

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由罗氏集团成员基因泰克公司开发。该公司保留了在美国的商业权利，而诺华则拥有世界其他地区的独家商业权利。

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，Lucentis已在120多个国家获得批准，用于治疗湿性AMD成年患者，并用于治疗因糖尿病性黄斑水肿（DME）、因视网膜分支静脉阻塞（BRVO）和视网膜中央静脉阻塞（CRVO）引起的黄斑水肿以及因脉络膜新生血管化（CNV）导致的视力损伤。

Lucentis Important Safety Information

朗视得重要安全信息

Lucentis is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the excipients in Lucentis. Hypersensitivity reactions may manifest as severe intraocular inflammation.

Lucentis禁用于眼部或眼周感染的患者，或对雷珠单抗或Lucentis中任何辅料已知过敏的患者。过敏反应可能表现为严重的眼内炎症。

Intravitreal injections, including those with Lucentis, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract.

玻璃体内注射，包括使用Lucentis的注射，可能引起眼内炎、视网膜脱离和医源性外伤性白内障。

Increases in intraocular pressure have been noted both pre-injection and post-injection with Lucentis.

注射Lucentis后，无论是注射前还是注射后，都观察到眼内压的增加。

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the Lucentis clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause)..

尽管在Lucentis的临床试验中观察到的动脉血栓栓塞事件（ATEs）发生率较低，但使用VEGF抑制剂进行玻璃体内注射后仍存在ATEs的潜在风险。ATEs定义为非致命性中风、非致命性心肌梗死或血管性死亡（包括原因不明的死亡）。

Fatal events occurred more frequently in patients with DME and DR at baseline treated monthly with Lucentis compared with control. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded..

与对照组相比，基线时患有DME和DR并每月接受Lucentis治疗的患者发生严重不良事件的频率更高。尽管严重不良事件的发生率较低，且死亡原因多为糖尿病并发症晚期患者的典型致死原因，但这些事件与玻璃体内使用VEGF抑制剂之间的潜在关系仍不能排除。

Retinal vasculitis and/or retinal vascular occlusion have been reported. Patients should be instructed to report any change in vision without delay.

已有视网膜血管炎和/或视网膜血管阻塞的报道。应指导患者立即报告任何视力变化。

In the Lucentis Phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular side effects included nasopharyngitis, anemia, nausea, and cough.

在Lucentis的III期临床试验中，最常见的眼部副作用包括结膜出血、眼痛、玻璃体漂浮物和眼内压升高。最常见的非眼部副作用包括鼻咽炎、贫血、恶心和咳嗽。

You may report side effects to the FDA at (800) FDA-1088 or

您可以向 FDA 报告副作用，电话号码是 (800) FDA-1088 或者

http://www.fda.gov/medwatch

http://www.fda.gov/medwatch

. You may also report side effects to Genentech at (888) 835-2555.

您也可以通过电话（888）835-2555向基因泰克报告副作用。

For additional safety information, please see Lucentis full Prescribing Information, available here:

有关更多安全信息，请参阅此处可获取的Lucentis完整处方信息：

http://www.gene.com/download/pdf/lucentis_prescribing.pdf

http://www.gene.com/download/pdf/lucentis_prescribing.pdf

.

。

About Genentech in Ophthalmology

关于基因泰克在眼科领域的介绍

Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases. .

基因泰克公司正在研究和开发针对一系列导致严重视力障碍和失明的眼部疾病的新疗法，这些疾病包括湿性年龄相关性黄斑变性 (AMD)、糖尿病性黄斑水肿 (DME)、糖尿病性视网膜病变 (DR)、地理性萎缩 (GA) 以及其他视网膜疾病。

About Genentech

关于基因泰克

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.

成立于40多年前的基因泰克是一家领先的生物技术公司，致力于发现、开发、生产和销售用于治疗患有严重和危及生命的疾病的药物。该公司隶属于罗氏集团，总部位于加利福尼亚州南旧金山。

For additional information about the company, please visit .

有关公司的更多信息，请访问。

https://www.gene.com

https://www.gene.com

.

。

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