Diabetic Retinopathy Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Diabetic Retinopathy Pipeline Insights 2025" report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in the Diabetic Retinopathy pipeline landscape. It covers the Diabetic Retinopathy pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Diabetic Retinopathy 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 Retinopathy Pipeline Report

* On August 18, 2025 (Monday), findings published online in JAMA Ophthalmology (August 14 edition) revealed that semaglutide therapy in adults with diabetes does not raise the risk of developing eye disorders or diabetic retinopathy.
* On August 15, 2025, Eyepoint Pharmaceuticals Inc . carried out a randomized, double-masked clinical trial assessing the ocular safety and efficacy of two different doses of the EYP-1901 IVT insert, compared with a sham treatment.
* On August 18, 2025, Genentech Inc. initiated a clinical trial designed to investigate both ocular and systemic safety, tolerability, and efficacy of RO7446603 in patients with diabetic macular edema (DME). The study includes two main parts: Phase I (Parts 1-4), which examined the safety of single and multiple intravitreal (IVT) doses as monotherapy or in combination with IVT aflibercept or IVT faricimab (administered separately), and Phase II (Part 5) for further evaluation.
* DelveInsight's Diabetic Retinopathy pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for Diabetic Retinopathy treatment.
* The leading Diabetic Retinopathy Companies such as Kodiak Sciences, Novartis, Regenxbio Inc., OcuTerra Therapeutics, Ocular Therapeutix, Bayer, RemeGen, Roche, Ocuphire Pharma, Adverum Biotechnologies, Boehringer Ingelheim , and others.
* Promising Diabetic Retinopathy Pipeline Therapies such as Runcaciguat (BAY1101042), OTT166, COLIRIOBCN070660, Brimonidine , and others.

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Diabetic Retinopathy Emerging Drugs Profile

* Tarcocimab tedromer: Kodiak Sciences

Tarcocimab is an investigational anti-VEGF therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate (""ABC"") Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents. Kodiak's objective with tarcocimab is to enable earlier treatment and prevention of vision loss for patients with diabetic retinopathy and to develop a new durability agent to improve outcomes for patients with retinal vascular diseases. Currently, the drug is in Phase III stage of its clinical trial for the treatment of diabetic retinopathy.

* OTT166: Ocuterra Therapeutics

Nesvategrast (OTT166) is an investigational, novel, patented, potent and selective small molecule RGD integrin inhibitor designed with purpose engineering to have an optimum balance of physiochemical properties to allow it to distribute to the retina in high concentrations after topical (eye drop) administration to the eye. In preclinical studies, nesvategrast selectively inhibited key RGD integrin subtypes, including v3, to regulate cellular responses to VEGF and other growth factors known to contribute to development and progression of diabetic retinopathy and other ocular diseases. In early clinical trials in patients with diabetic retinal disease, nesvategrast eye drops have demonstrated preliminary evidence of tolerability and biological activity. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Diabetic retinopathy.

* APX3330: Apexian Pharmaceuticals

APX3330 is a first-in-class, small molecule, oral inhibitor of the transcription factor regulator Ref-1 (reduction-oxidation effector factor-1). With a novel dual mechanism of action, APX3330 blocks the downstream pathways those involving angiogenesis (VEGF) and inflammation (NFkB) to decrease abnormal activation of both angiogenesis, and of inflammatory pathways that are implicated across several ocular diseases, including DR, DME, and age-related macular degeneration (AMD). APX3330 has shown a favorable safety and tolerability profile in 12 clinical trials conducted in healthy, hepatitis, cancer, and diabetic subjects. Currently, the drug is in Phase II stage of its clinical trial for the treatment of diabetic retinopathy.

OTX-TKI: Ocular Therapeutix

OTX-TKI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Diabetic retinopathy.

The Diabetic Retinopathy Pipeline report provides insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Diabetic Retinopathy 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 Retinopathy Treatment.
* Diabetic Retinopathy Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Diabetic Retinopathy 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 Retinopathy market

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Diabetic Retinopathy Companies

Kodiak Sciences, Novartis, Regenxbio Inc., OcuTerra Therapeutics, Ocular Therapeutix, Bayer, RemeGen, Roche, Ocuphire Pharma, Adverum Biotechnologies, Boehringer Ingelheim, and others.

Diabetic Retinopathy 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 Retinopathy Pipeline 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 Retinopathy Pipeline Report

* Coverage- Global
* Diabetic Retinopathy Companies- Kodiak Sciences, Novartis, Regenxbio Inc., OcuTerra Therapeutics, Ocular Therapeutix, Bayer, RemeGen, Roche, Ocuphire Pharma, Adverum Biotechnologies, Boehringer Ingelheim , and others.
* Diabetic Retinopathy Pipeline Therapies- Runcaciguat (BAY1101042), OTT166, COLIRIOBCN070660, Brimonidine , and others.
* Diabetic Retinopathy Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Diabetic Retinopathy Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

* Introduction
* Executive Summary
* Diabetic Retinopathy: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Diabetic Retinopathy- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* KSI-301: Kodiak Sciences
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* RGX 314: Regenxbio Inc
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* OTX-TKI: Ocular Therapeutix
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Diabetic Retinopathy Key Companies
* Diabetic Retinopathy Key Products
* Diabetic Retinopathy- Unmet Needs
* Diabetic Retinopathy- Market Drivers and Barriers
* Diabetic Retinopathy- Future Perspectives and Conclusion
* Diabetic Retinopathy Analyst Views
* Diabetic Retinopathy Key Companies
* Appendix

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