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DelveInsight’s, “Diabetic Macular Edema Pipeline Insight 2025” report provides comprehensive insights about 45+ companies and 50+ pipeline drugs in Diabetic Macular Edema pipeline landscape. It covers the Diabetic Macular Edema pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Diabetic Macular Edema pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Diabetic Macular Edema Pipeline Report

• In April 2025, Genentech Inc. announced a study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections).
• In April 2025, Bayer announced a study treatment, 8 milligram (mg) aflibercept is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye.
• In April 2025, Hoffmann-La Roche conducted a phase II study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 76 weeks.
• DelveInsight’s Diabetic Macular Edema Pipeline report depicts a robust space with 45+ active players working to develop 50+ pipeline therapies for Diabetic Macular Edema treatment.
• The leading Diabetic Macular Edema Companies such as Oculis, 4D Molecular Therapeutics, Ashvattha Therapeutics, Ocugen, AiViva BioPharma, Inc., Unity Biotechnology, Inc., Therini Bio Pty Ltd, Valo Health, Inc., Kyowa Kirin Co., Ltd., Invirsa, Inc., Frontera Therapeutics, EyePoint Pharmaceuticals, Inc., EyeBiotech Ltd., EnnovaBio, Eclipse Life Sciences, Inc., Merck & Co, Rezolute, Inc., Aviceda Therapeutics, KODIAK SCIENCES INC., AsclepiX Therapeutics and others.
• Promising Diabetic Macular Edema Pipeline Therapies such as Ranibizumab, Avastin (Bevacizumab), Ozurdex (dexamethasone), EXN407, IBE-814 70ug, Dexamethasone nanoparticles eye drops, EYP-1901 and others.

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Diabetic Macular Edema Emerging Drugs Profile

• OCS-01: Oculis

OCS-01 is an innovative high concentration eye drop candidate to treat DME. It is developed with the proprietary OPTIREACH® technology to enable drug passage from the anterior to the posterior segment of the eye following topical application, a route of administration that contrasts with currently available DME therapies, all requiring invasive delivery to reach the retina, such as ocular implants or intravitreal injections. The OPTIREACH® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby enabling the drug passage from the eye surface to the posterior segment of the eye. Currently, the drug is in Phase III stage of its development for the treatment of Diabetic Macular Edema.

• 4D-150: 4D Molecular Therapeutics

4D-150 combines the customized and evolved intravitreal vector, R100, and a transgene cassette that expresses both aflibercept and a VEGF-C inhibitory RNAi. This dual-transgene payload inhibits four members of the VEGF angiogenic family of factors that drive wet AMD and DME: VEGF A, B, C and PlGF. R100 was invented at 4DMT through the proprietary Therapeutic Vector Evolution platform. 4D-150 is designed for single, low-dose intravitreal delivery for transgene expression from the retina without significant inflammation. Currently, the drug is in Phase II stage of its development for the treatment of Diabetic Macular Edema.

• D-4517.2: Ashvattha Therapeutics

D-4517.2 is a potent anti-angiogenic nanomedicine (“dendranib”) that crosses the blood-retinal barrier and selectively targets activated microglia, macrophages and retinal pigment epithelial cells in the eye. D-4517.2 has the potential to change the current treatment paradigm for neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME) by offering an at-home dosing option by a subcutaneous route of administration rather than delivery via intravitreal injection (injection into the eye). Currently, the drug is in Phase II stage of its development for the treatment of Diabetic Macular Edema.

• OCU200: Ocugen

OCU200 is a biologic product candidate in development for treating severely sight-threatening diseases like diabetic macular edema (DME), diabetic retinopathy (DR), and wet age-related macular degeneration (Wet-AMD). OCU200 is a novel fusion protein consisting of two human proteins, tumstatin and transferrin, that are already present in retinal tissues. OCU200 has unique features, which enable it to efficiently target leaky blood vessels, regress the existing abnormal blood vessels, and inhibit the growth of new blood vessels in the retina and choroid. Tumstatin, which acts as an anti-VEGF, anti-inflammatory, and anti-oxidative agent, is the active component of OCU200. It binds to integrin receptors, which play a crucial role in disease pathogenesis. Transferrin facilitates the targeted delivery of tumstatin into the retina and choroid and potentially helps increase the interaction between tumstatin and integrin receptors. Currently, the drug is in Phase I stage of its development for the treatment of Diabetic Macular Edema.

• AIV007: AiViva BioPharma, Inc.

AIV007 is a novel formulation using JEL™ Technology designed for prolonged drug release. AIV007 targets multiple pathways including VEGFR, PDGFR, and FGFR to address neovascularization and fibrosis, and it also modulates TGFβ1 mRNA expression and TGFβ1 levels to reduce collagen production and scarring. In nonclinical in vivo studies for nAMD, AIV007 demonstrated safety, efficacy, and prolonged treatment duration with a single intravitreal administration. Ocular safety and effects in the reduction of neovascularization and fibrosis were observed in several nonclinical animal models and patients. Currently, the drug is in Phase I stage of its development for the treatment of Diabetic Macular Edema.

Diabetic Macular Edema Market Drivers

• Advances in Diabetic Macular Edema Treatment
• Improved Diagnostic Tools

Diabetic Macular Edema Market Barriers

• Diabetic Macular Edema Patient Adherence
• Side Effects and Safety Concerns associated Diabetic Macular Edema

The Diabetic Macular Edema Pipeline Report Provides Insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Diabetic Macular Edema with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Diabetic Macular Edema Treatment.
• Diabetic Macular Edema Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Diabetic Macular Edema Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Diabetic Macular Edema market

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Diabetic Macular Edema Companies

Oculis, 4D Molecular Therapeutics, Ashvattha Therapeutics, Ocugen, AiViva BioPharma, Inc., Unity Biotechnology, Inc., Therini Bio Pty Ltd, Valo Health, Inc., Kyowa Kirin Co., Ltd., Invirsa, Inc., Frontera Therapeutics, EyePoint Pharmaceuticals, Inc., EyeBiotech Ltd., EnnovaBio, Eclipse Life Sciences, Inc., Merck & Co, Rezolute, Inc., Aviceda Therapeutics, KODIAK SCIENCES INC., AsclepiX Therapeutics and others.

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
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Diabetic Macular Edema Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

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Scope of the Diabetic Macular Edema Pipeline Report

• Coverage- Global
• Diabetic Macular Edema Companies- Oculis, 4D Molecular Therapeutics, Ashvattha Therapeutics, Ocugen, AiViva BioPharma, Inc., Unity Biotechnology, Inc., Therini Bio Pty Ltd, Valo Health, Inc., Kyowa Kirin Co., Ltd., Invirsa, Inc., Frontera Therapeutics, EyePoint Pharmaceuticals, Inc., EyeBiotech Ltd., EnnovaBio, Eclipse Life Sciences, Inc., Merck & Co, Rezolute, Inc., Aviceda Therapeutics, KODIAK SCIENCES INC., AsclepiX Therapeutics and others.
• Diabetic Macular Edema Pipeline Therapies- Ranibizumab, Avastin (Bevacizumab), Ozurdex (dexamethasone), EXN407, IBE-814 70ug, Dexamethasone nanoparticles eye drops, EYP-1901 and others.
• Diabetic Macular Edema Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Diabetic Macular Edema Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

1. Introduction
2. Executive Summary
3. Diabetic Macular Edema: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Diabetic Macular Edema– DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. OCS-01: Oculis
9. Mid Stage Products (Phase II)
10. Early Stage Products (Phase I)
11. Preclinical and Discovery Stage Products
12. Drug Name: Company Name
13. Inactive Products
14. Diabetic Macular Edema Key Companies
15. Diabetic Macular Edema Key Products
16. Diabetic Macular Edema- Unmet Needs
17. Diabetic Macular Edema- Market Drivers and Barriers
18. Diabetic Macular Edema- Future Perspectives and Conclusion
19. Diabetic Macular Edema Analyst Views
20. Diabetic Macular Edema Key Companies
21. Appendix

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