Diabetic Macular Edema Clinical Trials and Drugs Analysis: EMA, PDMA, FDA Approvals, Medication, Therapies, NDA, IND, Treatment Market, Mechanism of Action, Route of Administration, and Companies by DelveInsight

(Albany, USA) DelveInsight's "Diabetic Macular Edema Pipeline Insight 2025" report offers an in-depth analysis of over 60 companies and 65+ pipeline drugs in the Diabetic Macular Edema treatment landscape. The report provides detailed profiles of both clinical and nonclinical stage pipeline drugs, along with a comprehensive assessment of therapeutics based on product type, development stage, route of administration, and molecule type. Additionally, it highlights inactive pipeline products within this domain.

Key Takeaways from the Diabetic Macular Edema Pipeline Report
• Over 60+ Diabetic Macular Edema companies are evaluating 65+ Diabetic Macular Edema pipeline therapies in various stages of development, and their anticipated acceptance in the Diabetic Macular Edema market would significantly increase market revenue.
• The leading Diabetic Macular Edema companies working in the market include Mylan Pharmaceuticals, Kodiak sciences, Celltrion, Exonate, Opthea, Asclepi X Therapeutics, Allgenesis Biotherapeutics, Ascentage Pharma, Rezolute, Ocuphire Pharma, Oxurion, MingSight Pharmaceuticals, Adverum Biotechnologies, and others.
• Promising Diabetic Macular Edema Pipeline Therapies in the various stages of development include MYL-1701P, Eylea, Dexamethasone ophthalmic suspension (OCS-01), REGN910-3, Intravitreal Aflibercept Injection (IAI), and others.
• In February 2025, Roche announced that the U.S. FDA granted approval for Susvimo® (ranibizumab injection) 100 mg/mL to treat diabetic macular edema (DME), a major cause of vision loss in adults with diabetes, impacting more than 29 million people globally.
• April 2024: AbbVie- A Multi-country, Post Marketing Observational Study of DME Patients With Suboptimal Response to Anti-VEGF Who Are Initiated With Dexamethasone Intravitreal Implant (DEX-I).
• April 2024: Bayer announced a study of Phase 4 clinical trials for Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321). The main purpose of this study is to collect more data to learn how safe intravitreal aflibercept is in Indian people with DME. To see how safe intravitreal aflibercept is, the researchers will collect the information/data on the medical problems the participants may have during the study, and which may or may not be related to the study treatment. These medical problems are also known as "adverse events" (AEs). AEs will be categorized according to relatedness, seriousness, discontinuation of therapy, action taken and outcome.

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In the Diabetic Macular Edema pipeline report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, Diabetic Macular Edema NDA approvals (if any), and product development activities comprising the technology, Diabetic Macular Edema collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Diabetic Macular Edema Overview
Diabetic Macular Edema (DME) is a complication of diabetic retinopathy that occurs when fluid accumulates in the macula, the central part of the retina responsible for sharp vision. This swelling leads to blurred or distorted vision and, if untreated, can result in significant vision loss. DME is a leading cause of blindness among individuals with diabetes, affecting millions worldwide. Risk factors include prolonged diabetes, poor blood sugar control, hypertension, and high cholesterol.

DME develops due to damage to retinal blood vessels caused by prolonged high blood sugar levels. This results in increased vascular permeability, leading to fluid leakage into the macula. Symptoms include blurry or wavy vision, difficulty reading, and color distortion. Diagnosis is confirmed through optical coherence tomography (OCT) and fluorescein angiography, which assess retinal thickness and vascular leakage.

Treatment options for DME include intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) agents like ranibizumab, aflibercept, and bevacizumab, which reduce fluid leakage and improve vision. Corticosteroids and laser photocoagulation may also be used in certain cases. Emerging therapies, including sustained-release implants and gene therapy, are being explored to enhance long-term disease management. Early detection and timely treatment are crucial in preserving vision in DME patients.

Find out more about Diabetic Macular Edema Therapeutics Assessment @ Diabetic Macular Edema Preclinical and Discovery Stage Products- https://www.delveinsight.com/sample-request/diabetic-macular-edema-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Diabetic Macular Edema Emerging Therapies Profile
• MYL-1701P: Mylan Pharmaceuticals
MYL-1701P (also referred to as M710, as part of a partnership with Momenta Pharmaceuticals) is perhaps the aflibercept biosimilar that is furthest along in the development process. It is currently the subject of a 324-patient phase III trial. Mylan is to handle development and commercialization.

• KSI-301: Kodiak sciences
KSI-301 is a novel anti-VEGF biologic built on a propriety antibody biopolymer conjugate (ABC) platform KSI-301 is designed to have extended ocular half-life, higher potency, and improved ocular tissue bioavailability. KSI-301 is administered as an intravitreal injection and designed to provide sustained inhibition of VEGF for up to 6 months. The unique properties of KSI- 301 aim to provide patients with long-term control of their DME with improved vision outcomes while reducing the burden of frequent anti-VEGF injections. In addition, KSI-301 is designed to halt and reverse DR progression with long-term efficacy that can reduce the risk of vision-threatening complications from DR. The Phase III GLEAM and GLIMMER studies are global, multi-center, randomized studies designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve diabetic macular edema (DME).

• CT-P42: Celltrion
CT-P42, an aflibercept biosimilar referencing Regeneron's Eylea. The trial will enroll 300 patients with diabetic macular edema, and aims to compare CT-P42's efficacy, safety, pharmacokinetics, and immunogenicity against Eylea.Currently, the drug is in Phase III stage of Clinical trial evaluation for the treatment of diabetic macular edema (DME)

Diabetic Macular Edema Therapeutics Assessment
There are approx. 60+ key Diabetic Macular Edema companies which are developing the Diabetic Macular Edema therapies. The Diabetic Macular Edema companies which have their Diabetic macular edema drug candidates in the most advanced stage, i.e. Phase III include, Mylan Pharmaceuticals.

DelveInsight's Diabetic Macular Edema pipeline report covers around 65+ products under different phases of clinical development like
• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Diabetic macular edema pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Diabetic Macular Edema Products have been categorized under various Molecule types such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Learn more about the emerging Diabetic Macular Edema Pipeline Therapies @ Diabetic Macular Edema Clinical Trials Assessment- https://www.delveinsight.com/report-store/diabetic-macular-edema-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Scope of the Diabetic Macular Edema Pipeline Report
• Coverage- Global
• Diabetic Macular Edema Companies- Mylan Pharmaceuticals, Kodiak sciences, Celltrion, Exonate, Opthea, Asclepi X Therapeutics, Allgenesis Biotherapeutics, Ascentage Pharma, Rezolute, Ocuphire Pharma, Oxurion, MingSight Pharmaceuticals, Adverum Biotechnologies, and others.
• Diabetic Macular Edema Pipeline Therapies- MYL-1701P, Eylea, Dexamethasone ophthalmic suspension (OCS-01), REGN910-3, Intravitreal Aflibercept Injection (IAI), and others.
• Diabetic Macular Edema Pipeline Segmentation: Product Type, Molecule Type, Route of Administration, Mechanism of Action

Dive deep into rich insights for drugs for Diabetic Macular Edema Pipeline Companies and Therapies, click here @ Diabetic Macular Edema Unmet Needs and Analyst Views- https://www.delveinsight.com/sample-request/diabetic-macular-edema-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Content
1. Introduction
2. Executive Summary
3. Diabetic macular edema: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Late Stage Products (Phase III)
7. MYL-1701P: Mylan Pharmaceuticals
8. Drug profiles in the detailed report…..
9. Mid Stage Products (Phase II)
10. Drug Name: Company Name
11. Drug profiles in the detailed report…..
12. Early stage products (Phase I)
13. Drug Name: Company Name
14. Drug profiles in the detailed report…..
15. Inactive Products
16. Diabetic macular edema Key Companies
17. Diabetic macular edema Key Products
18. Diabetic macular edema- Unmet Needs
19. Diabetic macular edema- Market Drivers and Barriers
20. Diabetic macular edema- Future Perspectives and Conclusion
21. Diabetic macular edema Analyst Views
22. Diabetic macular edema Key Companies
23. Appendix

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