Seven months after the FDA approved the reintroduction of Roche's eye implant Susvimo, the US agency has expanded its approved use to include treatment for diabetic macular edema, the primary cause of blindness related to diabetes. This marks the second approved indication for Susvimo, which was initially cleared in .

FDA批准罗氏眼植入物Susvimo重新引入七个月后，美国监管机构已扩大其批准用途，包括治疗糖尿病性黄斑水肿——这是糖尿病相关失明的主要原因。这是Susvimo获得的第二个批准适应症，其最初获批是在此前。

October 2021

2021年10月

as an alternative to frequent eye injections for wet age-related macular degeneration.

作为一种替代湿性年龄相关性黄斑变性频繁眼部注射的方法。

LAS VEGAS

拉斯维加斯

,

，

April 30, 2025

2025年4月30日

/PRNewswire/ -- Diabetic macular edema is a complication that develops from diabetic retinopathy, a widespread consequence of diabetes and a leading cause of irreversible vision loss in working-age adults globally. Diabetic retinopathy occurs due to long-term damage to the retina's small blood vessels, leading to fluid leakage and swelling—especially in the macula.

/PRNewswire/ -- 糖尿病性黄斑水肿是由糖尿病视网膜病变发展而来的一种并发症，糖尿病视网膜病变是糖尿病的普遍后果，也是全球工作年龄成年人不可逆视力丧失的主要原因之一。糖尿病视网膜病变由于视网膜小血管长期受损而发生，导致液体渗漏和肿胀，尤其是在黄斑区域。

As per DelveInsight's analysis, there were about .

根据DelveInsight的分析，大约有 。

1.9 million

190万

prevalent cases of DME across the 7MM in 2023, with numbers expected to grow at a notable CAGR during the forecast period.

2023年7MM中DME的普遍病例，预计在预测期内将以显著的复合年增长率增长。

The primary treatment for DME includes intravitreal injections, where the eye is numbed with drops before injecting medication directly into the vitreous humor. Common anti-VEGF drugs used include

DME的主要治疗方式包括玻璃体内注射，即先用滴眼液麻痹眼睛，然后将药物直接注入玻璃体。常用的抗VEGF药物包括

AVASTIN, EYLEA, and LUCENTIS

阿瓦斯汀、艾力雅和路易康尼斯

. Additionally, corticosteroids are beneficial in cases of DME linked to inflammatory eye conditions and can be delivered via eye drops, oral tablets, or periocular injections to help reduce inflammation. The US FDA approved sustained-release corticosteroid implants for more serious or longer-lasting conditions, are .

此外，皮质类固醇在与炎症性眼病相关的糖尿病性黄斑水肿（DME）病例中具有益处，可以通过眼药水、口服片剂或眼球周围注射来减轻炎症。美国FDA已经批准了用于更严重或更持久情况的缓释型皮质类固醇植入物。

OZURDEX, RETISERT, and ILUVIEN.

奥扎德克斯、雷蒂塞特和伊卢维恩。

Learn more about the diabetic macular edema treatment @

了解更多关于糖尿病性黄斑水肿的治疗 @

New Treatment for Diabetic Macular Edema

糖尿病性黄斑水肿的新疗法

EYLEA (Regeneron Pharmaceuticals)

EYLEA（再生元制药）

– Aflibercept is a recombinant fusion protein composed of the VEGF-binding regions derived from the extracellular domains of human VEGF receptors 1 and 2, linked to the Fc segment of human IgG1. It functions as a VEGF trap by binding to circulating vascular endothelial growth factors (VEGFs), thereby neutralizing VEGF-A, VEGF-B, and placental growth factor (PGF).

– 阿柏西普是一种重组融合蛋白，由源自人类VEGF受体1和2的细胞外结构域的VEGF结合区域组成，并与人类IgG1的Fc片段连接。它通过结合循环中的血管内皮生长因子（VEGFs）充当VEGF陷阱，从而中和VEGF-A、VEGF-B和胎盘生长因子（PGF）。

This action inhibits the formation of new blood vessels in the tumor's choriocapillaris. In .

该作用抑制肿瘤脉络膜毛细血管中新的血管生成。

July 2014

2014年7月

, the U.S. FDA approved EYLEA (aflibercept) Injection for treating diabetic macular edema (DME).

美国食品药品监督管理局（FDA）批准了EYLEA（阿柏西普）注射液用于治疗糖尿病性黄斑水肿（DME）。

Ranibizumab (Genentech)

雷珠单抗（基因泰克）

– Marketed as LUCENTIS, ranibizumab is a monoclonal antibody fragment (Fab) derived from the same original mouse antibody as bevacizumab. It is an anti-angiogenic therapy used to treat the 'wet' form of age-related macular degeneration (AMD), a leading cause of vision loss in older adults. Ranibizumab has shown comparable effectiveness to bevacizumab.

——作为LUCENTIS销售的雷珠单抗是一种单克隆抗体片段（Fab），与贝伐单抗源自相同的原始鼠源抗体。它是一种抗血管生成疗法，用于治疗年龄相关性黄斑变性（AMD）的“湿性”形式，这是导致老年人视力丧失的主要原因之一。雷珠单抗显示出与贝伐单抗相当的有效性。

Developed by Genentech, it is marketed in the U.S. by Genentech and internationally by Novartis. The FDA approved ranibizumab for the treatment of DME in 2012..

由基因泰克公司开发，在美国由基因泰克公司销售，国际上由诺华公司销售。2012年，FDA批准雷珠单抗用于治疗糖尿病性黄斑水肿（DME）。

In

在

February 2025

2025年2月

, Roche announced that the FDA had approved Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema (DME), a major cause of vision loss in adults with diabetes. This approval is based on positive one-year data from the phase III Pagoda trial, which demonstrated that Susvimo offered sustained improvements in vision for individuals with DME, with a safety profile consistent with what is already known for the drug.

罗氏宣布，FDA 已批准 Susvimo（雷珠单抗注射液）100 mg/mL 用于治疗糖尿病性黄斑水肿 (DME)，这是糖尿病成人患者视力丧失的主要原因之一。此项批准基于 III 期 Pagoda 试验的积极一年数据，该数据显示 Susvimo 为 DME 患者提供了持续的视力改善，其安全性与该药物已知的信息一致。

In the study, patients receiving Susvimo refills every six months experienced vision gains comparable to those receiving monthly intravitreal injections of 0.5 mg ranibizumab (9.6 letters versus 9.4 letters on an eye chart, equivalent to about two lines of vision improvement)..

在研究中，每六个月接受Susvimo补充治疗的患者视力改善程度与每月接受0.5毫克雷珠单抗玻璃体内注射的患者相当（视力表上分别为9.6个字母和9.4个字母，相当于约两行视力改善）。

Susvimo delivers a specially formulated version of ranibizumab continuously through the Port Delivery Platform, offering a less frequent dosing alternative compared to other treatments that may require monthly eye injections. The FDA initially approved Susvimo in 2021 for the treatment of neovascular age-related macular degeneration (nAMD).

Susvimo通过Port Delivery平台持续输送一种特殊配方的雷珠单抗，相比其他可能需要每月眼部注射的治疗方法，提供了频率更低的给药选择。美国食品药品监督管理局（FDA）于2021年首次批准Susvimo用于治疗新生血管性年龄相关性黄斑变性（nAMD）。

Regulatory reviews in other countries are currently underway..

其他国家的监管审查目前正在进行中。

Learn more about the FDA-approved DME drugs @

了解更多关于FDA批准的DME药物 @

Drugs for Diabetic Macular Edema Treatment

糖尿病性黄斑水肿治疗药物

Key players, such as

关键玩家，如

Oculis, Rezolute, AsclepiX Therapeutics

奥库利斯、雷索卢特、阿斯克勒庇X治疗公司

, and others, are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of diabetic macular edema. The DME market has a promising outlook with the emerging therapies. Some of the drugs in the pipeline are .

，以及其他公司，分别在临床开发的不同阶段评估他们的主要候选药物。他们旨在研究其用于治疗糖尿病性黄斑水肿的产品。随着新兴疗法的出现，DME市场前景广阔。一些在研药物是 。

OCS-01, RZ402, AXT107

OCS-01，RZ402，AXT107

, and others.

，以及其他。

DME leads to significant vision loss in diabetics, affecting up to 7.9% of type 1 and 12.8% of type 2 diabetes patients.

糖尿病性黄斑水肿（DME）会导致糖尿病患者视力严重下降，影响高达7.9%的1型糖尿病患者和12.8%的2型糖尿病患者。

AbbVie

艾伯维

, in collaboration with

，与...合作

REGENEXBIO

再生生物екс

, is developing the gene therapy

，正在开发基因疗法

ABBV-RGX-314

ABBV-RGX-314

. This therapy targets wet age-related macular degeneration, diabetic retinopathy (DR), and other chronic retinal diseases, potentially offering a breakthrough in treating these conditions.

这种疗法针对湿性年龄相关性黄斑变性、糖尿病视网膜病变 (DR) 和其他慢性视网膜疾病，可能会为治疗这些疾病提供突破。

Discover which therapies are expected to grab major DME market share @

了解哪些治疗方案有望占据主要的DME市场份额 @

Diabetic Macular Edema Market Report

糖尿病性黄斑水肿市场报告

OCS-01

OCS-01

is a high-concentration dexamethasone eye drop developed for diabetic macular edema (DME), utilizing the proprietary Optireach solubilizing platform. This technology enhances drug solubility, allows for higher concentrations, prolongs ocular retention, and improves bioavailability in eye tissues, including the retina. .

是一种用于治疗糖尿病性黄斑水肿 (DME) 的高浓度地塞米松滴眼液，利用了专有的 Optireach 增溶平台。该技术提高了药物的溶解度，允许更高的浓度，延长了眼部滞留时间，并提升了包括视网膜在内的眼组织中的生物利用度。

Recently, in

最近，在

April 2025

2025年4月

, Oculis announced the completion of patient enrollment for its Phase 3

，Oculis宣布已完成其第三阶段的患者入组工作

DIAMOND-1 and DIAMOND-2 clinical trials

钻石-1和钻石-2临床试验

evaluating OCS-01 eye drops for diabetic macular edema (DME). These pivotal registration studies aim to support global regulatory filings, including a New Drug Application (NDA) submission and potential approval by the U.S. FDA. Over 800 patients were enrolled across 119 sites in the U.S. and other countries..

评估OCS-01滴眼液治疗糖尿病性黄斑水肿（DME）的效果。这些关键的注册研究旨在支持全球监管申报，包括新药申请（NDA）提交及美国FDA的潜在批准。研究共在119个地点招募了800多名患者，覆盖美国及其他国家。

The swift completion of enrollment in the DIAMOND program—comprising two double-masked, randomized, multi-center Phase 3 trials—is a significant milestone. These studies are assessing the efficacy and safety of OCS-01 over a 52-week treatment period in patients with DME. Topline results are anticipated in Q2 2026, followed by an NDA submission..

DIAMOND 项目迅速完成入组是一个重要的里程碑，该项目包括两项双盲、随机、多中心的 III 期试验。这些研究正在评估 OCS-01 在 DME 患者中为期 52 周治疗期的有效性和安全性。预计将在 2026 年第二季度公布初步结果，随后提交新药申请 (NDA)。

If approved, OCS-01 would be the first topical eye drop treatment for DME, offering a novel therapeutic option for early intervention and for patients who do not adequately respond to anti-VEGF therapies.

如果获得批准，OCS-01 将成为首个用于治疗 DME 的局部眼药水，为早期干预以及对抗 VEGF 疗法反应不佳的患者提供一种新颖的治疗选择。

RZ402

RZ402

is an oral small-molecule drug that selectively inhibits plasma kallikrein (PK) for the long-term treatment of DME. By blocking kallikrein activation, RZ402 aims to prevent bradykinin-driven vascular leakage and inflammation. Phase II results revealed a significant reduction in central subfield thickness (CST) across all dosing levels, with improvements of up to ~50 microns compared to placebo.

是一种口服小分子药物，可选择性抑制血浆激肽释放酶（PK），用于糖尿病性黄斑水肿（DME）的长期治疗。通过阻断激肽释放酶的激活，RZ402旨在防止缓激肽引发的血管渗漏和炎症。二期临床试验结果显示，在所有剂量水平下，中央子区域厚度（CST）均显著减少，与安慰剂相比，改善幅度高达约50微米。

The treatment was well tolerated and showed a favorable safety profile..

该治疗耐受性良好，并显示出良好的安全性。

AXT107

AXT107

targets two validated mechanisms for treating retinal vascular diseases: it inhibits the pro-angiogenic receptor VEGFR2 and activates the vessel-stabilizing Tie2 receptor. These effects are mediated through its interaction with integrins αvβ3 and α5β1. AXT107 is formulated as a microparticulate suspension designed for intraocular injection and is currently undergoing Phase I/II clinical trials, according to the company's development pipeline..

靶向治疗视网膜血管疾病的两种已验证机制：抑制促血管生成受体VEGFR2并激活稳定血管的Tie2受体。这些效应是通过其与整合素αvβ3和α5β1的相互作用介导的。AXT107被配制成用于眼内注射的微粒悬浮液，根据公司的研发管线，目前正在进行I/II期临床试验。

Discover more about drugs for DME in development @

了解更多关于DME药物的开发进展 @

Diabetic Macular Edema Clinical Trials

糖尿病性黄斑水肿临床试验

The anticipated launch of these emerging therapies for DME are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the DME market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth..

这些新兴 DME 疗法的预期推出，有望在未来几年内彻底改变市场格局。随着这些前沿疗法不断成熟并获得监管批准，它们预计将重塑 DME 市场，提供新的护理标准，并为医疗创新和经济增长带来机遇。

DelveInsight estimates that the market size for DME is expected to grow from

德尔维洞察估计，DME的市场规模预计会从

USD 3 billion

30亿美元

in 2023, with a significant CAGR by 2034. Owing to the higher patient pool and higher diabetic macular edema treatment cost, according to the estimates,

2023年，到2034年将实现显著的复合年均增长率。由于患者群体较大及糖尿病性黄斑水肿治疗成本较高，根据估算，

the United States

美国

had the highest market size in DME, i.e.,

在DME中拥有最高的市场规模，即，

~60%

约60%

of the total market size of DME in the 7MM, in 2023, followed by

在7MM中，DME的总市场规模，2023年，其次是

Germany

德国

and

和

Japan

日本

.

。

DelveInsight's analysis forecasts market growth due to the introduction of emerging therapies, expecting a rise in market size during the study period (2020–2034). The anticipated increase in market size is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies..

DelveInsight的分析预测，由于新兴疗法的引入，市场将实现增长，并预计在研究期间（2020-2034年）内市场规糢将有所扩大。市场规糢的预期增长得益于治疗方案的进步、医疗保健覆盖范围的扩大以及该疾病患病率的上升，这些因素共同推动了对创新和有效疗法的更高需求。

DelveInsight's latest published market report, titled as

德尔维洞察最新发布的市场报告，标题为

Diabetic Macular Edema Market Insight, Epidemiology, and Market Forecast – 2034

糖尿病性黄斑水肿市场洞察、流行病学与市场预测——2034年

,

，

will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the DME country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential.

将帮助您发现哪个市场领导者将占据最大的市场份额。该报告提供了对DME国家特定治疗指南、患者群体分析和流行病学预测的全面洞察，以帮助理解关键机会并评估市场的潜在潜力。

The DME market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:.

DME市场报告在2020年至2034年的研究期间内，对7MM进行了流行病学分析，具体细分如下：。

Total Prevalent Cases of DME

DME的总流行病例数

Total Diagnosed Prevalent Cases of DME

DME总诊断患病数

Gender-specific Diagnosed Prevalent Cases of DME

DME的性别特异性确诊病例数

Age-Specific Diagnosed Prevalent Cases of DME

DME的年龄特异性诊断患病率病例数

Subgroup-specific Diagnosed Prevalent Cases of DME

DME的亚组特定诊断患病病例数

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM DME market. Highlights include:

该报告通过了解影响和推动七大市场（7MM）DME市场的趋势，为制定商业策略提供了优势。亮点包括：

10-year Forecast

10年预测

7MM Analysis

7MM分析

Epidemiology-based Market Forecasting

基于流行病学的市场预测

Historical and Forecasted Market Analysis upto 2034

历史和预测市场分析直至2034年

Emerging Drug Market Uptake

新兴药物市场吸收率

Peak Sales Analysis

峰值销售分析

Key Cross Competition Analysis

关键交叉竞争分析

Industry Expert's Opinion

行业专家意见

Access and Reimbursement

获取与报销

Download this DME market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the DME market. Also, stay abreast of the mitigating factors to improve your market position in the DME therapeutic space..

下载这份DME市场报告，评估流行病学预测，了解患者旅程，知晓关键意见领袖（KOLs）对即将到来的治疗模式的看法，并确定影响DME市场变化的因素。同时，紧跟缓解因素，以提升您在DME治疗领域的市场地位。

Related Reports

相关报告

Diabetic Macular Edema Epidemiology Forecast

糖尿病性黄斑水肿流行病学预测

Diabetic Macular Edema Epidemiology Forecast – 2034

糖尿病性黄斑水肿 流行病学预测 – 2034

report delivers an in-depth understanding of the disease, historical and forecasted diabetic macular edema epidemiology in the 7MM, i.e.,

报告深入介绍了该疾病，并对7MM中的糖尿病性黄斑水肿的历史和预测流行病学进行了分析，即

the United States

美国

, EU5 (

，欧盟5（

Germany

德国

,

，

Spain

西班牙

,

，

Italy

意大利

,

，

France

法国

, and the

，以及

United Kingdom

英国

), and

），以及

Japan

日本

.

。

Diabetic Macular Edema Pipeline

糖尿病性黄斑水肿治疗管道

Diabetic Macular Edema Pipeline Insight

糖尿病性黄斑水肿治疗管道洞察

– 2025

– 2025

report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic macular edema companies, including

报告全面洞察了糖尿病性黄斑水肿的管线情况、管线药物概况（包括临床和非临床阶段产品）以及主要公司，其中包括

Mylan Pharmaceuticals, Kodiak Sciences, Celltrion, Exonate, Opthea, AsclepiX Therapeutics, Allgenesis Biotherapeutics, Ascentage Pharma, Rezolute, Ocuphire Pharma, Oxurion, MingSight Pharmaceuticals, Adverum Biotechnologies,

迈兰制药、科迪亚克科学、Celltrion、Exonate、Opthea、AsclepiX治疗、Allgenesis生物治疗、亚盛医药、Rezolute、Ocuphire制药、Oxurion、MingSight制药、Adverum生物技术

among others.

其中包括。

Diabetic Retinopathy Market

糖尿病视网膜病变市场

Diabetic Retinopathy Market Insights, Epidemiology, and Market Forecast – 2034

糖尿病视网膜病变市场洞察、流行病学与市场预测 – 2034

report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetic retinopathy companies, including

报告深入介绍了该疾病、历史和预测的流行病学，以及市场趋势、市场驱动力、市场障碍和主要糖尿病视网膜病变公司，包括

Genentech, Inc., Regeneron Pharmaceuticals, Roche, Opthea Limited, Regenxbio, Kodiak Sciences Inc, Ocuphire Pharma, Eisai Co Ltd, Apexian Pharmaceuticals, Oculis,

基因泰克公司、再生元制药、罗氏、Opthea有限公司、Regenxbio、Kodiak科学公司、Ocuphire制药、卫材株式会社、Apexian制药、Oculis

among others.

其中包括。

Diabetic Retinopathy Pipeline

糖尿病视网膜病变管线

Diabetic Retinopathy Pipeline Insight

糖尿病视网膜病变管线洞察

– 2025

– 2025

report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic retinopathy companies, including

报告提供了关于研发管线的全面见解，包括临床和非临床阶段产品的管线药物概况，以及关键的糖尿病视网膜病变公司，包括

Kodiak Sciences, Novartis, Regenxbio Inc., OcuTerra Therapeutics, Ocular Therapeutix, Bayer, RemeGen, Roche, Ocuphire Pharma, Adverum Biotechnologies, Boehringer Ingelheim, Palatin Technologies, Valo Health, EyePoint Pharmaceuticals, Kubota Vision, MingSight Pharmaceuticals, Oxurion, Aerie Pharmaceuticals,  AsclepiX Therapeutics, Ocugen, Ashvattha Therapeutics, Stealth BioTherapeutics, .

Kodiak Sciences、诺华、Regenxbio Inc.、OcuTerra Therapeutics、Ocular Therapeutix、拜耳、荣昌生物、罗氏、Ocuphire Pharma、Adverum Biotechnologies、勃林格殷格翰、Palatin Technologies、Valo Health、EyePoint Pharmaceuticals、Kubota Vision、MingSight Pharmaceuticals、Oxurion、Aerie Pharmaceuticals、AsclepiX Therapeutics、Ocugen、Ashvattha Therapeutics、Stealth BioTherapeutics。

among others.

其中包括。

About DelveInsight

关于DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

德尔维洞察（DelveInsight）是一家领先的商业咨询和市场研究公司，专注于生命科学领域。它通过提供全面的端到端解决方案来支持制药公司以提升其业绩。通过我们的订阅平台 PharmDelve，您可以轻松获取所有医疗保健和制药市场研究报告。

.

。

Contact Us

联系我们

Shruti Thakur

舒鲁蒂·塔库尔

info@delveinsight.com

info@delveinsight.com

+14699457679

+14699457679

Logo:

标志：

https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg

https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg

SOURCE DelveInsight Business Research, LLP

来源：DelveInsight商业研究公司

WANT YOUR COMPANY'S NEWS

想要你公司的新闻

FEATURED ON PRNEWSWIRE.COM?

刊登在PRNEWSWIRE.COM上？

440k+

44万+

Newsrooms &

新闻编辑室 &

Influencers

影响者

9k+

9k+

Digital Media

数字媒体

Outlets

插座

270k+

27万+

Journalists

记者

Opted In

已选择加入

GET STARTED

开始使用