Diabetic macular edema (DME) is a serious eye condition resulting from fluid buildup in the macula due to diabetic retinopathy, leading to vision impairment. As per Ahmed Sermed Al Sakini et al., 2024, 20-30% of DME patients may lose at least three lines of vision within three years if untreated. The current drug pipeline includes promising candidates such as Faricimab, KSI-301, and AR-1105. According to the diabetic macular edema pipeline analysis by Expert Market Research, growing R&D initiatives and targeted therapies are set to drive advancements in the treatment landscape.
Major companies involved in the diabetic macular edema pipeline analysis include RemeGen Co., Ltd., EyeBiotech Ltd., and others.
Leading drugs currently in the pipeline include EYE103, OXU-001, MS-553, and others.
The pipeline is expanding due to increasing clinical trials of anti-VEGF biosimilars, rising investment in gene therapies, and regulatory support for novel intravitreal treatments.
The Diabetic Macular Edema Pipeline Analysis Report by Expert Market Research gives comprehensive insights into diabetic macular edema therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for diabetic macular edema. The diabetic macular edema report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The diabetic macular edema pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with diabetic macular edema treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to diabetic macular edema.
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Diabetic macular edema (DME) is a diabetes-related eye condition where fluid builds up in the macula, the central part of the retina responsible for sharp vision. It occurs when high blood sugar levels damage retinal blood vessels, causing them to leak fluid into the macula and leading to vision impairment or loss.
Diabetic macular edema is treated using anti-vascular endothelial growth factor (VEGF) injections, corticosteroids, or laser therapy to reduce fluid accumulation, prevent further damage, and preserve visual acuity. In August 2023, the U.S. Food and Drug Administration approved EYLEA HD (aflibercept) Injection 8 mg for DME treatment. It demonstrated clinically equivalent vision gains with extended dosing intervals in the PHOTON trial, enhancing patient convenience and treatment outcomes.
Diabetic macular edema (DME) remains a leading cause of vision impairment in individuals with diabetes. According to Ahmed Sermed Al Sakini et al., 2024, 20%–30% of untreated DME patients may lose at least three lines of vision within three years. As reported by Hanna Heloterä et al., 2024, the incidence of DME in Finland is 1.8 cases per 1,000 person-years. The American Academy of Ophthalmology states that the 25-year incidence of DME in individuals with Type 1 Diabetes Mellitus is 29%. According to Daniel Samacá-Samacá et al., 2025, DME affects approximately 1 in 15 diabetic patients globally, with a prevalence of 5.14% in high-income countries and 5.81% in low- and middle-income regions.
This section of the report covers the analysis of diabetic macular edema drug candidates based on several segmentations, including:
By Phase
By Drug Class
By Route of Administration
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total diabetic macular edema clinical trials (around 37%), highlighting strong ongoing research in drug development. Phase III accounts for 23%, followed by phase I at 22%. Phase IV contributes 13%. These advancing stages reflect growing innovation and are expected to impact the treatment landscape positively.
The drug molecule categories covered under the diabetic macular edema pipeline analysis include small molecules, monoclonal antibodies, biologics, RNA therapies, and cell therapies. The diabetic macular edema report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for diabetic macular edema. Anti-vascular endothelial growth factor (anti-VEGF) agents remain the cornerstone in the treatment pipeline for diabetic macular edema. For instance, aflibercept and ranibizumab are under continued evaluation for enhanced dosing strategies. Additionally, non-VEGF therapies such as senolytic agents like UBX1325 are gaining momentum, targeting cellular aging processes to reduce retinal inflammation and improve visual outcomes.
The EMR report for the diabetic macular edema pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed diabetic macular edema therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in diabetic macular edema clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for diabetic macular edema. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of diabetic macular edema drug candidates.
EYE103, sponsored by EyeBiotech Ltd., is currently being evaluated in a Phase 2/3 pivotal study for treating diabetic macular edema (DME). The objective of this phase is to examine the efficacy and safety of two dose levels of EYE103 compared to 0.5 mg ranibizumab. EYE103 is a tetravalent antibody-like molecule targeting Frizzled-4 and LRP5, administered via intravitreal injection to modulate retinal vascular stability.
OXU-001, sponsored by Oxular Limited, is currently being evaluated in a Phase 2 trial for the treatment of diabetic macular edema. This study is comparing two dose levels of OXU-001-dexamethasone microspheres (DEXAspheres®)-delivered via the Oxulumis® microcatheter, against intravitreal Ozurdex®. The objective is to examine safety, efficacy, and durability. OXU-001 is a sustained-release, suprachoroidal formulation designed for targeted, long-lasting ocular drug delivery.
MS-553 is being sponsored by Shenzhen MingSight Relin Pharmaceuticals Co., Ltd., and is currently under evaluation in a Phase 1 dose-escalation study for treatment-naïve diabetic retinopathy patients with center-involving diabetic macular edema (DME). The study is examining the safety and treatment effects of MS-553, a selective oral PKC-β inhibitor, administered over 8 weeks to assess its impact on retinal thickness, volume, and visual acuity. The trial is actively recruiting participants.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Diabetic Macular Edema Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for diabetic macular edema. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into diabetic macular edema collaborations, regulatory environments, and potential growth opportunities.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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