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Diabetic Macular Edema Pipeline 2025: MOA, ROA, FDA-Approved Drugs, and Clinical Trial Progress Assessment by DelveInsight

08-13-2025 08:07 PM CET | Health & Medicine

Press release from: DelveInsight Business Research

Diabetic Macular Edema Pipeline 2025: MOA, ROA, FDA-Approved

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Diabetic Macular Edema pipeline constitutes key companies continuously working towards developing Diabetic Macular Edema treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Diabetic Macular Edema Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Diabetic Macular Edema Market.

The Diabetic Macular Edema Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Diabetic Macular Edema Pipeline Report: https://www.delveinsight.com/sample-request/diabetic-macular-edema-dme-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Diabetic Macular Edema treatment therapies with a considerable amount of success over the years.
• Diabetic Macular Edema companies working in the treatment market are Surrozen, AskGene Pharma, Inc., Therini Bio Pty Ltd, Innovent Biologics Technology Limited, Kodiak sciences, Oculis, Eluminex BioSciences, Ocugen, Innovent biologics, Curacle, GlaxoSmithKline, Exonate Limited, Ocuphire Pharma, Unity Biotechnology, Allgenesis Biotherapeutics Inc., Mylan, Kodiak Sciences, Novartis, Roche, Kodiak Sciences, Adverum Biotechnologies, Graybug Vision, Oxurion, Novartis, YD Life Science, Allegro, Opthalmics/Bausch Health, Clearside Biomedical, KalVista Pharmaceuticals, and others, are developing therapies for the Diabetic Macular Edema treatment
• Emerging Diabetic Macular Edema therapies in the different phases of clinical trials are- SZN 8143, EB-105, ASKG712, THN391, IBI302, Tarcocimab tedromer, OCS-01, EB-102, OCU200, IBI324, CU06-1004, GSK-2798745, EXN407, APX3330, UBX1325, AG-73305, MYL-1701P, KSI-301, BEOVU (RTH258; brolucizumab), VABYSMO (faricimab), KSI-301, ADVM-022, GB-102, THR-149, LKA651, YD-312, Luminate (ALG-1001, Risuteganib), Xipere (CLS-TA), KVD001, and others are expected to have a significant impact on the Diabetic Macular Edema market in the coming years.
• In July 2025, Boehringer Ingelheim has announced the initiation of the Phase II THULITE clinical trial, which will assess the efficacy, safety, and tolerability of BI 1815368, an oral treatment for diabetic macular edema (DME).
• In July 2025, ANI Pharmaceuticals, Inc. reported results from the NEW DAY clinical trial evaluating ILUVIEN® (fluocinolone acetonide intravitreal implant), 0.19 mg, for the treatment of patients with diabetic macular edema (DME).
• In May 2025, Innovent Biologics has administered the first dose to a patient in its Phase II clinical trial evaluating efdamrofusp alfa for treating diabetic macular edema (DME).
• In March 2025, Unity Biotechnology reported topline results from its Phase 2b ASPIRE clinical trial evaluating intravitreal UBX1325 in patients with diabetic macular edema (DME) who continued to experience poor vision despite prior anti-VEGF therapy. The trial data includes outcomes for all participants through 24 weeks and most through 36 weeks. ASPIRE (NCT06011798) is a multi-center, randomized, double-masked, active-controlled Phase 2b study. A total of 52 patients were enrolled and randomly assigned in a 1:1 ratio to receive either 10 μg of UBX1325 or 2 mg of aflibercept every 8 weeks for six months following randomization.
• In March 2025, Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness-related conditions, announced that the Data and Safety Monitoring Board (DSMB) has reviewed safety data from the first cohort in the dose-escalation phase of its Phase 1 OCU200 clinical trial. Based on this evaluation, the DSMB has given the green light to begin dosing the second cohort. OCU200 is an innovative fusion protein combining tumstatin and transferrin, being developed as a potential therapy for diabetic macular edema (DME).
• In February 2025, EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), focused on developing innovative therapies for serious retinal diseases, has shared promising six-month data from its ongoing Phase 2 VERONA trial of DURAVYUTM (vorolanib intravitreal insert). This investigational, sustained-release treatment utilizes the company's proprietary bioerodible Durasert ETM platform to deliver the selective tyrosine kinase inhibitor, vorolanib. The study successfully met its primary endpoint by significantly delaying the need for supplemental injections compared to the aflibercept control group in both DURAVYU dosage arms. Notably, patients experienced sustained visual improvement and anatomical stability, with no serious ocular or systemic adverse events related to DURAVYU. At week 24, the 2.7mg dose group achieved a +7.1 letter improvement in best corrected visual acuity (BCVA) and a 76-micron decrease in central subfield thickness (CST), with 73% of patients avoiding supplemental injections versus 50% in the aflibercept group. These results highlight DURAVYU's strong therapeutic promise for treating severe retinal conditions.
• In January 2025, Ocugen, Inc. (NASDAQ: OCGN), a biotechnology firm focused on developing cutting-edge gene and cell therapies, biologics, and vaccines, has announced that the first patient has been successfully dosed in its Phase 1 clinical trial of OCU200, a potential treatment for diabetic macular edema (DME).

Diabetic Macular Edema Overview
Diabetic Macular Edema (DME) is a complication of diabetes that affects the eyes. It occurs when the macula, which is the central part of the retina responsible for sharp, central vision, swells due to the accumulation of fluid. DME is a type of diabetic retinopathy, a condition that can affect individuals with diabetes.

Get a Free Sample PDF Report to know more about Diabetic Macular Edema Pipeline Therapeutic Assessment-
https://www.delveinsight.com/report-store/diabetic-macular-edema-dme-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Emerging Diabetic Macular Edema Drugs Under Different Phases of Clinical Development Include:
• SZN 8143: Surrozen
• ASKG712: AskGene Pharma, Inc.
• THN391: Therini Bio Pty Ltd
• IBI302: Innovent Biologics Technology Limited
• Tarcocimab tedromer: Kodiak sciences
• OCS-01: Oculis
• EB-102: Eluminex BioSciences
• OCU200: Ocugen
• IBI324: Innovent biologics
• CU06-1004: Curacle
• GSK-2798745: GlaxoSmithKline
• EXN407: Exonate Limited
• APX3330: Ocuphire Pharma
• UBX1325: Unity Biotechnology
• AG-73305: Allgenesis Biotherapeutics Inc.
• MYL-1701P: Mylan
• KSI-301: Kodiak Sciences
• BEOVU (RTH258; brolucizumab): Novartis
• VABYSMO (faricimab): Roche
• KSI-301: Kodiak Sciences
• ADVM-022: Adverum Biotechnologies
• GB-102: Graybug Vision
• THR-149: Oxurion
• LKA651: Novartis
• YD-312: YD Life Science
• Luminate (ALG-1001, Risuteganib): Allegro Opthalmics/Bausch Health
• Xipere (CLS-TA): Clearside Biomedical
• KVD001: KalVista Pharmaceuticals

Diabetic Macular Edema Pipeline Therapeutics Assessment
• Diabetic Macular Edema Assessment by Product Type
• Diabetic Macular Edema By Stage and Product Type
• Diabetic Macular Edema Assessment by Route of Administration
• Diabetic Macular Edema By Stage and Route of Administration
• Diabetic Macular Edema Assessment by Molecule Type
• Diabetic Macular Edema by Stage and Molecule Type

DelveInsight's Diabetic Macular Edema Report covers around products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Diabetic Macular Edema product details are provided in the report. Download the Diabetic Macular Edema pipeline report to learn more about the emerging Diabetic Macular Edema therapies
https://www.delveinsight.com/sample-request/diabetic-macular-edema-dme-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the Diabetic Macular Edema Therapeutics Market include:
Key companies developing therapies for Diabetic Macular Edema are - Oxurion, Ocuphire Pharma, YD Life Science, Unity Biotechnology, Novartis, Roche, Kodiak Sciences, Adverum Biotechnologies, Graybug Vision, Allegro Opthalmics, Bausch Health, Clearside Biomedical, KalVista Pharmaceuticals, and others.

Diabetic Macular Edema Pipeline Analysis:
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 key 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.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Diabetic Macular Edema drugs and therapies
https://www.delveinsight.com/sample-request/diabetic-macular-edema-dme-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Diabetic Macular Edema Pipeline Market Drivers
• Growing Prevalence of diabetes, development of novel therapies, investment in Research and Development activities are some of the important factors that are fueling the Diabetic Macular Edema Market.

Diabetic Macular Edema Pipeline Market Barriers
• However, high medical cost, lack of approved therapies and other factors are creating obstacles in the Diabetic Macular Edema Market growth.

Scope of Diabetic Macular Edema Pipeline Drug Insight
• Coverage: Global
• Key Diabetic Macular Edema Companies: Surrozen, AskGene Pharma, Inc., Therini Bio Pty Ltd, Innovent Biologics Technology Limited, Kodiak sciences, Oculis, Eluminex BioSciences, Ocugen, Innovent biologics, Curacle, GlaxoSmithKline, Exonate Limited, Ocuphire Pharma, Unity Biotechnology, Allgenesis Biotherapeutics Inc., Mylan, Kodiak Sciences, Novartis, Roche, Kodiak Sciences, Adverum Biotechnologies, Graybug Vision, Oxurion, Novartis, YD Life Science, Allegro, Opthalmics/Bausch Health, Clearside Biomedical, KalVista Pharmaceuticals, and others
• Key Diabetic Macular Edema Therapies: SZN 8143, EB-105, ASKG712, THN391, IBI302, Tarcocimab tedromer, OCS-01, EB-102, OCU200, IBI324, CU06-1004, GSK-2798745, EXN407, APX3330, UBX1325, AG-73305, MYL-1701P, KSI-301, BEOVU (RTH258; brolucizumab), VABYSMO (faricimab), KSI-301, ADVM-022, GB-102, THR-149, LKA651, YD-312, Luminate (ALG-1001, Risuteganib), Xipere (CLS-TA), KVD001, and others
• Diabetic Macular Edema Therapeutic Assessment: Diabetic Macular Edema current marketed and Diabetic Macular Edema emerging therapies
• Diabetic Macular Edema Market Dynamics: Diabetic Macular Edema market drivers and Diabetic Macular Edema market barriers

Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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