Diabetic Macular Edema Market Outlook 2034 - Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

FDA Expands Approval of Roche's Eye Implant Susvimo to Diabetic Macular Edema - A Landmark Development in Retinal Disease Treatment
Diabetic Macular Edema Market Outlook 2034 - Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

FDA Expands Approval of Roche's Eye Implant Susvimo to Diabetic Macular Edema - A Landmark Development in Retinal Disease Treatment

Diabetic macular edema Market Summary

Diabetic macular edema (DME), a complication of diabetic retinopathy (DR), is the leading cause of irreversible vision loss among working-age adults worldwide. DR occurs due to long-term retinal vessel damage, leading to fluid leakage and swelling in the macula. In 2023, the United States accounted for ~60% of the Diabetic macular edema market in the 7MM, driven by a higher patient pool and treatment costs, followed by Germany and Japan. Treatment options include anti-VEGF therapies, corticosteroids, and laser photocoagulation, with anti-VEGFs remaining the gold standard. Off-label bevacizumab use persists among nearly half of U.S. ophthalmologists, though its usage is lower in EU4 and the UK, with modest adoption in Japan. Diabetic macular edema Market growth is fueled by the rising diabetes burden from aging and sedentary lifestyles, alongside the introduction of emerging therapies offering efficacy comparable to current standards but with less frequent dosing. In March 2022, the EU approved Novartis' BEOVU for Diabetic macular edema, expanding its treatment scope.

DelveInsight's "Diabetic Macular Edema Market Insights, Epidemiology, and Market Forecast - 2034" provides a comprehensive overview of the Diabetic Macular Edema (DME) landscape, covering historical data, current trends, and future projections across the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.

This latest healthcare market report delivers a detailed analysis of the DME space, offering valuable insights into prevalence, revenue patterns, and the evolving treatment ecosystem. It outlines crucial market statistics, including present and forecasted market size, while evaluating the clinical progress and potential of emerging therapies. In addition, the report reviews the pipeline of ongoing and upcoming DME clinical trials, shedding light on innovative approaches that are set to redefine treatment strategies. Serving as a strategic resource, it enables stakeholders to better understand the market dynamics, key epidemiological trends, and the rapidly expanding therapeutic landscape of Diabetic Macular Edema.

Download Diabetic Macular Edema Market Report to explore epidemiology forecasts, pipeline therapies, and competitive landscape shaping the future of DME treatment @ Diabetic Macular Edema Market Size and Share Analysis [https://www.delveinsight.com/report-store/diabetic-macular-edema-dme-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Seven months after the FDA approved the reintroduction of Roche's eye implant Susvimo, the U.S. regulatory body has expanded its use to include treatment for diabetic macular edema (DME) - the leading cause of diabetes-related blindness. This marks the second approved indication for Susvimo, which was initially cleared in October 2021 as an alternative to frequent intravitreal injections for wet age-related macular degeneration (nAMD).

The approval represents a significant advancement in the diabetic macular edema treatment landscape, offering patients a less burdensome and more sustained therapeutic option.

Key Takeaways from Diabetic Macular Edema (DME) Market Report

* According to DelveInsight's analysis, there were approximately 1.9 million prevalent cases of DME across the 7MM (US, EU4, UK, Japan) in 2023.
* The Diabetic Macular Edema patient pool is expected to grow at a notable CAGR throughout the forecast period (2020-2034).
* Diabetic Macular Edema affects up to 7.9% of type 1 diabetes patients and 12.8% of type 2 diabetes patients, representing a large global healthcare challenge.
* Diabetic Macular Edema remains one of the leading causes of irreversible blindness in working-age adults worldwide, highlighting the urgent need for long-acting, effective therapies.

* Diabetic macular edema is a serious complication of diabetic retinopathy, a condition caused by chronic damage to retinal blood vessels due to prolonged diabetes. The damage leads to fluid leakage and swelling in the macula, the central portion of the retina responsible for sharp vision.
* In May 2025, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Susvimo Registered (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the US 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. Susvimo is now available to US retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
* In April 2025, Oculis Holding AG (Nasdaq: OCS / ICX: OCS.IC) ("Oculis"), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced that it has completed enrollment in both Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in DME, designed as pivotal registration studies to support global marketing applications including NDA submission and approval by the U.S. Food and Drug Administration (FDA). The trials enrolled over 800 patients at 119 investigative sites throughout the United States and several other countries.

Gain Strategic Advantage - From patient pool analytics to pipeline drug uptake, our Diabetic Macular Edema Market Forecast (2020-2034) offers actionable intelligence for pharma, biotech, and investors @ Diabetic Macular Edema Patient Pool Forecast [https://www.delveinsight.com/sample-request/diabetic-macular-edema-dme-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Current Standard of Care for Diabetic Macular Edema

The primary treatment for Diabetic Macular Edema involves intravitreal injections of anti-VEGF drugs, where medications are injected directly into the vitreous humor of the eye.

* EYLEA (aflibercept, Regeneron Pharmaceuticals): A recombinant fusion protein acting as a VEGF trap, approved for DME in 2014.
* LUCENTIS (ranibizumab, Genentech/Novartis): A monoclonal antibody fragment targeting VEGF, FDA-approved for DME in 2012.
* AVASTIN (bevacizumab, off-label use): Widely used for cost-effectiveness but not specifically approved for DME.

For patients with inflammation-driven DME, corticosteroids (delivered via eye drops, oral tablets, or periocular injections) are commonly used. Sustained-release corticosteroid implants such as OZURDEX, RETISERT, and ILUVIEN are FDA-approved for more persistent cases.

Discover how FDA approvals, emerging drugs, and evolving clinical trials will redefine the Diabetic Macular Edema market by 2034. Access the full report today @ Diabetic Macular Edema Clinical Trials and Competitive Landscape [https://www.delveinsight.com/sample-request/diabetic-macular-edema-dme-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Susvimo: A New Chapter in Diabetic Macular Edema Treatment

In February 2025, Roche announced FDA approval of Susvimo (ranibizumab injection, 100 mg/mL) for treating diabetic macular edema.

* Clinical Data: The approval was based on positive Phase III Pagoda trial results, where Susvimo demonstrated sustained visual improvements comparable to monthly ranibizumab injections.
* Efficacy Results: Patients receiving Susvimo refills every six months achieved +9.6 letters on an eye chart, comparable to the +9.4 letters achieved with monthly intravitreal injections.
* Mechanism: Susvimo continuously delivers ranibizumab via the Port Delivery System (PDS), reducing injection frequency while maintaining consistent therapeutic benefit.

This makes Susvimo a less burdensome, long-acting therapy compared to conventional anti-VEGF regimens, positioning it as a transformative option in the DME treatment market.

Diabetic Macular Edema Competitive Landscape

Some of the leading pharma and biotech companies in the Diabetic Macular Edema market include Adverum Biotechnologies, Allergan (AbbVie, Molecular Partners, Allergo Opthalmics/ Bausch Health, Clearside Biomedical, Graybug Vision, KalVista Pharmaceuticals, Kodiak Sciences, Novartis, Ocuphire Pharma, Oxurion, Roche, YD Life Science, and many others.

Emerging Therapies for Diabetic Macular Edema

The Diabetic Macular Edema pipeline is dynamic, with multiple companies developing next-generation therapies that could further reshape the market.

Key Diabetic Macular Edema Pipeline Therapies

* OCS-01 (Oculis):

* A high-concentration dexamethasone eye drop using the proprietary Optireach platform.
* In April 2025, Oculis completed patient enrollment in DIAMOND-1 and DIAMOND-2 Phase III trials with 800+ patients across 119 sites.
* If approved, OCS-01 would be the first topical eye drop treatment for DME, providing a convenient alternative to injections.

* RZ402 (Rezolute):

* An oral plasma kallikrein (PK) inhibitor, designed for long-term management of DME.
* Phase II trials showed ~50 micron reductions in central subfield thickness (CST) with strong safety and tolerability.

* AXT107 (AsclepiX Therapeutics):

* A dual-mechanism therapy that inhibits VEGFR2 and activates the Tie2 receptor.
* Delivered via intraocular injection, currently in Phase I/II development.

* ABBV-RGX-314 (AbbVie/REGENEXBIO):

* A gene therapy candidate targeting wet AMD, DR, and DME.
* Aims to deliver long-lasting VEGF suppression with a single administration.

These emerging therapies are expected to drive next-generation treatment strategies for DME and expand therapeutic choices beyond injections.

Diabetic Macular Edema Market Outlook

According to DelveInsight's Diabetic Macular Edema Market Report (2020-2034):

* The Diabetic Macular Edema market size was approximately USD 3 billion in 2023.
* The Diabetic Macular Edema market is forecasted to grow significantly, driven by emerging therapies, higher prevalence, and rising treatment costs.
* The United States accounted for ~60% of the total Diabetic Macular Edema market size in 2023, followed by Germany and Japan.

* Diabetic Macular Edema Market growth will be accelerated by:

* The launch of novel therapies like Susvimo, OCS-01, RZ402, and ABBV-RGX-314.
* Improved patient access to ophthalmology care.
* Increasing prevalence of diabetes-related complications.

Learn which therapies and companies are poised to capture the largest market share in the DME space. Get DelveInsight's detailed market outlook now @ Diabetic Macular Edema Market Outlook and Trends [https://www.delveinsight.com/report-store/diabetic-macular-edema-dme-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Report Coverage: Diabetic Macular Edema Market Insight

The Diabetic Macular Edema Market Report provides:

* Epidemiological analysis (2020-2034) across the 7MM:

* Total prevalent cases of DME
* Diagnosed patient segments (age, gender, subgroup-specific)

* 10-year market forecast with epidemiology-driven modeling
* Competitive landscape analysis of marketed and pipeline drugs
* Market access and reimbursement trends
* Unmet needs, opportunities, and analyst insights

The report offers a strategic edge for pharma companies, investors, and healthcare stakeholders aiming to understand DME treatment dynamics and capture opportunities in this evolving market.

Discover which therapy is expected to dominate the DME market share in 2034: Diabetic Macular Edema Market Report [https://www.delveinsight.com/sample-request/diabetic-macular-edema-dme-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Analysts Commentary

The FDA's expansion of Susvimo to treat diabetic macular edema marks a pivotal milestone in retinal disease management, offering a long-lasting, less invasive alternative to frequent injections. With a robust pipeline including OCS-01 eye drops, RZ402 oral therapy, AXT107 intraocular injections, and gene therapy ABBV-RGX-314, the DME treatment landscape is undergoing rapid transformation.

As the patient burden grows worldwide, innovative therapies are expected to redefine the standard of care, improve quality of life for millions, and drive significant market expansion through 2034.

About DelveInsight

DelveInsight is a leading life sciences market research and business consulting company recognized for its syndicated market research reports and customized solutions. With expertise spanning drug development, market forecasting, epidemiology, and competitive intelligence, DelveInsight empowers healthcare organizations to make informed strategic decisions

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