Roche's Susvimo FDA Approval Marks New Era in Diabetic Macular Edema Treatment Market | DelveInsight
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 October 2021 as an alternative to frequent eye injections for wet age-related macular degeneration.
LAS VEGAS, April 30, 2025 /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. As per DelveInsight's analysis, there were about 1.9 million prevalent cases of DME across the 7MM in 2023, with numbers expected to grow at a notable CAGR during the forecast period.
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 AVASTIN, EYLEA, and LUCENTIS. 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 OZURDEX, RETISERT, and ILUVIEN.
Learn more about the diabetic macular edema treatment @ New Treatment for Diabetic Macular Edema
EYLEA (Regeneron Pharmaceuticals) – 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). This action inhibits the formation of new blood vessels in the tumor's choriocapillaris. In July 2014, the U.S. FDA approved EYLEA (aflibercept) Injection for treating diabetic macular edema (DME).
Ranibizumab (Genentech) – 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. 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.
In February 2025, 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. 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).
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). Regulatory reviews in other countries are currently underway.
Learn more about the FDA-approved DME drugs @ Drugs for Diabetic Macular Edema Treatment
Key players, such as Oculis, Rezolute, AsclepiX Therapeutics, 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 OCS-01, RZ402, AXT107, and others.
DME leads to significant vision loss in diabetics, affecting up to 7.9% of type 1 and 12.8% of type 2 diabetes patients. AbbVie, in collaboration with REGENEXBIO, is developing the gene therapy 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.
Discover which therapies are expected to grab major DME market share @ Diabetic Macular Edema Market Report
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.
Recently, in April 2025, Oculis announced the completion of patient enrollment for its Phase 3 DIAMOND-1 and DIAMOND-2 clinical trials 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.
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.
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.
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. The treatment was well tolerated and showed a favorable safety profile.
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.
Discover more about drugs for DME in development @ Diabetic Macular Edema Clinical Trials
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.
DelveInsight estimates that the market size for DME is expected to grow from USD 3 billion 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, the United States had the highest market size in DME, i.e., ~60% of the total market size of DME in the 7MM, in 2023, followed by Germany and Japan.
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's latest published market report, titled as Diabetic Macular Edema Market Insight, Epidemiology, and Market Forecast – 2034, 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. The DME market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
- Total Prevalent Cases of DME
- Total Diagnosed Prevalent Cases of DME
- Gender-specific Diagnosed Prevalent Cases of DME
- Age-Specific Diagnosed Prevalent Cases of DME
- Subgroup-specific Diagnosed Prevalent Cases of DME
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM DME market. Highlights include:
- 10-year Forecast
- 7MM Analysis
- Epidemiology-based Market Forecasting
- Historical and Forecasted Market Analysis upto 2034
- Emerging Drug Market Uptake
- Peak Sales Analysis
- Key Cross Competition Analysis
- Industry Expert's Opinion
- Access and Reimbursement
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.
Related Reports
Diabetic Macular Edema Epidemiology Forecast
Diabetic Macular Edema Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted diabetic macular edema epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Diabetic Macular Edema Pipeline
Diabetic Macular Edema Pipeline Insight – 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 Mylan Pharmaceuticals, Kodiak Sciences, Celltrion, Exonate, Opthea, AsclepiX Therapeutics, Allgenesis Biotherapeutics, Ascentage Pharma, Rezolute, Ocuphire Pharma, Oxurion, MingSight Pharmaceuticals, Adverum Biotechnologies, among others.
Diabetic Retinopathy Market Insights, Epidemiology, and Market Forecast – 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 Genentech, Inc., Regeneron Pharmaceuticals, Roche, Opthea Limited, Regenxbio, Kodiak Sciences Inc, Ocuphire Pharma, Eisai Co Ltd, Apexian Pharmaceuticals, Oculis, among others.
Diabetic Retinopathy Pipeline Insight – 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 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, among others.
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