Diabetic Retinopathy Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Diabetic Retinopathy Treatment Landscape. Click here to read more @ Diabetic Retinopathy Pipeline Outlook
Key Takeaways from the Diabetic Retinopathy Pipeline Report
In March 2025:- Vantage Biosciences Ltd announced a study to evaluate the Efficacy and Safety of Orally Administered VX-01 in Diabetic Retinopathy of Non-Proliferative Type (NPDR).
In March 2025:- Invirsa Inc. announced a phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with non-center involved DME (NCIDME) associated with NPDR [Part 1] and during an 8-week dosing period in subjects with center-involved DME (CIDME) associated with NPDR [Part 1].
In March 2025:- Incepta Pharmaceuticals Ltd conducted a study to to Compare Efficacy & Safety Between Ranibizumab 10mg/ml Injection of Incepta and Lucentis in Patients With Diabetic Macular Edema by ITV Injection.
In March 2025:- EyePoint Pharmaceuticals Inc. announced a study of Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Diabetic Macular Edema (DME).
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.
Discover groundbreaking developments in Diabetic Retinopathy therapies! Gain in-depth knowledge of key Diabetic Retinopathy clinical trials, emerging drugs, and market opportunities @ Diabetic Retinopathy Clinical Trials Assessment
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 αvβ3, 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
Stay informed about the Diabetic Retinopathy pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Diabetic Retinopathy Unmet Needs
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
Transform your understanding of the Diabetic Retinopathy Pipeline! See the latest progress in drug development and clinical research @ Diabetic Retinopathy Market Drivers and Barriers, and Future Perspectives
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
Dive deep into rich insights for new drugs for Diabetic Retinopathy Treatment, Visit @ Diabetic Retinopathy Market Drivers and Barriers, and Future Perspective
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
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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Website: https://www.delveinsight.com/report-store/diabetic-retinopathy-pipeline-insight
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These leading causes of vision loss affect around 70 million people worldwide and can have a serious impact on patients, their families, and caregivers. 3,4,5,6 "The recent reimbursement for RVO in Quebec is a significant step forward for people living with the condition," said Dr. Ananda (Andy) Kalevar, Associate Professor, Department of Ophthalmology at Sherbrooke University, Quebec. "It gives ophthalmologists a valuable treatment option and provides patients with access to a medication that may ultimately offer the best outcomes for their vision." Roche Canada is committed to continuing to work with remaining provincial jurisdictions to make Vabysmo available through public and private drug plans for those living with RVO. About retinal vein occlusion (RVO) RVO is the second most common cause of vision loss due to retinal vascular conditions. It affects an estimated 28 million adults globally, mainly those aged 60 or older, and can lead to severe and sudden vision loss. 3,7 There are two main types of RVO: branch RVO (BRVO), which affects more than 23 million people globally and occurs when one of the four smaller 'branches' of the main central retinal vein becomes blocked; and central RVO (CRVO), which is less common, affecting more than four million people worldwide, and occurs when the eye's central retinal vein becomes blocked. 3,8 The levels of Vascular Endothelial Growth Factor A (VEGF-A) and angiopoietin-2 (Ang-2) are elevated in RVO and it is thought that their increased expression drives disease progression. 9,10 RVO typically results in sudden, painless vision loss in the affected eye because the vein blockage restricts normal blood flow in the affected retina, resulting in ischemia, bleeding, fluid leakage and retinal swelling called macular edema. 7,11,8 The safety and efficacy of Vabysmo for the treatment of macular edema secondary to retinal vein occlusion (RVO) were assessed in two randomised, multi-centre, double-masked, studies in patients with macular edema secondary to BRVO (BALATON) or CRVO/hemiretinal vein occlusion (HRVO) (COMINO). 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We are committed to creating a world where we all have more time with the people we love. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries. Having the courage to reinvent ourselves and question the status quo is what patients and healthcare systems expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs nearly 2,000 people at its offices in Mississauga, Ontario, in Laval, Quebec, and across the country from coast to coast to coast. For more information, please visit or follow Roche Canada on LinkedIn. References [1] RAMQ List of medications. Available at: Accessed on August 14, 2025. [2] Vabysmo Product Monograph, July 25, 2025 [3] Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019; 9:010427. Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019; 9:010427. [4] Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012; 35:556–64. [5] Connolly E, et al. Prevalence of age-related macular degeneration associated genetic risk factors and 4-year progression data in the Irish population. Br J Ophthalmol. 2018;102:1691–95. [6] Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [7] Moorfields Eye Hospital, United Kingdom National Health Service Foundation Trust. RVO [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [8] Campochiaro P. Molecular pathogenesis of retinal and choroidal vascular diseases. Prog Retin Eye Res. 2015; 49:67-81. [9] Joussen et al. Angiopoietin/Tie2 signalling and its role in retinal and choroidal vascular diseases: a review of preclinical data. Eye. 2021; 35:1305-1316. [10] Regula JT, et al. Targeting key angiogenic pathways with a bispecific CrossMab optimised for neovascular eye diseases. EMBO Molecular Medicine. 2016; 8:1265–88. [11] Schmidt-Erfurth U, et al. Guidelines for the management of retinal vein occlusion by the European society of retina specialists (EURETINA). Ophthalmologica. 2019; 242:123-162. [12] U.S. Food and Drug Administration (FDA). Highlights of prescribing information, aflibercept 2 mg. 2022. [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [13] FDA. Highlights of prescribing information, Vabysmo. 2022. [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [14] FDA approves Genentech's Vabysmo for the treatment of RVO [Internet; cited August 2025]. Available from: Accessed on August 6, 2025 [15] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [16] European Medicines Agency. Summary of product characteristics, Vabysmo, 2022 [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [17] Roche Data on File SOURCE Hoffmann-La Roche Limited (Roche Canada)
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Early Stage Products (Phase I) RYZ101: RayzeBio, Inc. Preclinical and Discovery Stage Products Drug Name: Company Name Inactive Products Extensive Stage Small Cell Lung Cancer (ESCLC) Key Companies Extensive Stage Small Cell Lung Cancer (ESCLC) Key Products Extensive Stage Small Cell Lung Cancer (ESCLC)- Unmet Needs Extensive Stage Small Cell Lung Cancer (ESCLC)- Market Drivers and Barriers Extensive Stage Small Cell Lung Cancer (ESCLC)- Future Perspectives and Conclusion Extensive Stage Small Cell Lung Cancer (ESCLC) Analyst Views Extensive Stage Small Cell Lung Cancer (ESCLC) Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
