Diabetic Retinopathy Pipeline, Clinical Trials Assessment, NDA Approvals 2023 (Updated) | Kodiak Sciences, Novartis, Regenxbio Inc., OcuTerra Therapeutics, and others.

DelveInsight's, "Diabetic Retinopathy Pipeline Insight 2023" 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 Diabetic Retinopathy clinical trials 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.

Key Takeaways from the Diabetic Retinopathy Pipeline Report

• DelveInsight's Diabetic Retinopathy Pipeline analysis depicts a robust space with 50+ active players working to develop 55+ pipeline treatment therapies.

• The leading Diabetic Retinopathy Companies include 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 include KSI-301, Brolucizumab, Runcaciguat, RC 28 E, AKB-9778, RG7774, RGX-314, APX3330, ADVM-022, THR-687, OCX 063, BI 764524, MS-553, NG004, RBM-008, BSL01, PYC001, PMC 403, PL8177, PL9654, LY-09004, CU 06, BNC-1601, APX 1004, UBX 1967, EG-Mirotin, AT 003, FP-008, GLY-230, HLX 04, EYP-1901 and many others.

• The Diabetic Retinopathy Companies and academics are working to assess challenges and seek opportunities that could influence Diabetic Retinopathy R&D. The Diabetic Retinopathy pipeline therapies under development are focused on novel approaches to treat/improve Diabetic Retinopathy.

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Diabetic Retinopathy Overview
Diabetic Retinopathy is a serious sight-threatening complication of diabetes. Diabetes interferes with the body's ability to use and store sugar (glucose). The disease is characterized by too much sugar in the blood, which can cause damage throughout the body, including the eyes.

Recent Developmental Activities in the Diabetic Retinopathy Treatment Landscape

• In May 2022, EyePoint Pharmaceuticals announced the EYP-1901 license to Betta Pharmaceuticals, to develop and commercialize EYP-1901 in China, Hong Kong, Macau, and Taiwan. EyePoint retains all rights for EYP-1901 in the rest of the world and expands its exclusive rights to local delivery of vorolanib for the treatment of all ophthalmic diseases, including diabetic macular edema (DME). Phase 2 clinical trial for EYP-1901 in non-proliferative diabetic retinopathy (NPDR) is expected to initiate in 2H 2022.

• In April 2022, Ocuphire Pharma presented masked safety data from the ongoing ZETA-1 Phase 2b trial of oral APX3330 for the treatment of diabetic retinopathy. The results show a favorable ophthalmic and systemic safety and tolerability profile, consistent with 11 prior safety trials of APX3330 in non-ophthalmic indications. The company expects to report top-line results from the ZETA-1 trial in the second half of 2022.

• In January 2022, Ocuphire Pharma entered into an agreement with Apexian Pharmaceuticals, Inc., granting Ocuphire an exclusive worldwide sublicense to Apexian's Ref-1 Inhibitor program, including its lead drug candidate APX3330, for all ophthalmic and diabetic indications.

• The Therapeutic candidate KSI-301, currently in clinical development being produced by Kodiak Sciences is a novel anti-VEGF biologic designed to have an extended ocular half-life. KSI-301 is being developed in Phase III stage of Diabetic Retinopathy Pipeline development towards a once every four to six-month treatment regimen - a possible game changer that may provide the opportunity for real prevention.

• Brolucizumab (RTH258) is a humanized single-chain antibody fragment (scFv) and the most clinically advanced, humanized single-chain antibody fragment developed by Novartis. Currently, it is in the Phase III stage of development to treat Diabetic Retinopathy.

• In September 2021, AbbVie and REGENXBIO entered into a strategic partnership combining eye care and gene therapy expertise to develop and commercialize RGX-314, investigational gene therapy for wet age-related macular degeneration, diabetic retinopathy, and other chronic retinal diseases. REGENXBIO to receive $370 million upfront payment from AbbVie.

• REGENXBIO announced additional positive interim data from the ongoing Phase II ALTITUDE trial of RGX-314 for the treatment of diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME) using in-office suprachoroidal delivery. RGX-314 continues to be well tolerated at six months following a one-time, in-office injection, with nearly 50 percent of patients dosed with RGX-314 in Cohort 1 demonstrating a clinically meaningful improvement from baseline.

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Diabetic Retinopathy Emerging Drugs Profile

• KSI-301: Kodiak Sciences
The Therapeutic candidate KSI-301, currently in clinical development, is a novel anti-VEGF biologic designed to have an extended ocular half-life. Ischemia due to vein occlusion results in secretion of vascular endothelial growth factor (VEGF) that causes further vascular leakage and edema. Anti-VEGF agents have become a very common treatment to improve the clinical outcomes in patients with diabetic retinopathy. As in wet AMD, an intensive treatment frequency is required to achieve optimal outcomes with currently-approved anti-VEGFs agents. However, many patients are lost to follow up due to the frequent injections and real-world outcomes in diabetic retinopathy do not meet the promise shown in clinical trials. By extending on mechanism treatment interval, KSI-301 may relieve the high treatment burden for patients, their family members, and physicians. KSI-301 is being developed in Phase III stage of development towards a once every four to six-month treatment regimen - a possible gamechanger that may provide the opportunity for real prevention.

• Brolucizumab: Novartis
Brolucizumab (RTH258) is a humanized single-chain antibody fragment (scFv) and the most clinically advanced, humanized single-chain antibody fragment to reach this stage of development. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics. The proprietary innovative structure results in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms. In preclinical studies, brolucizumab inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction. Increased signaling through the VEGF pathway is associated with pathologic ocular angiogenesis and retinal edema. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions, resolve retinal edema and improve vision in patients with chorioretinal vascular diseases. Currently, it is in Phase III stage of development to treat Diabetic Retinopathy.

• RGX 314: Regenxbio Inc.
RGX-314 is being developed as a novel, one-time subretinal treatment that includes the NAV AAV8 vector containing a gene encoding for a monoclonal antibody fragment. The expressed protein is designed to neutralize vascular endothelial growth factor (VEGF) activity, modifying the pathway for formation of new leaky blood vessels and retinal fluid accumulation. The company is currently enrolling patients in ALTITUDETM, a Phase II trial for the treatment of diabetic retinopathy using suprachoroidal delivery of RGX-314.

OTT-166: OcuTerra Therapeutics
OTT-166 is a novel small molecule selective integrin inhibitor that OcuTerra has purpose-engineered to have the required physiochemical characteristics to be able to reach the retina from eye drop application. Phase 1b clinical trials of OTT-166 eye drops have demonstrated safety, tolerability, and clear clinical evidence of biological activity. OcuTerra is currently studying the safety, efficacy, and optimal dosing regimen of OTT166 through the Phase II DR: EAM (Diabetic Retinopathy: Early Active Management) study in patients with moderately-severe to severe non-proliferative and mild proliferative diabetic retinopathy.

OTX-TKI: Ocular Therapeutix
OTX-TKI is an investigational bioresorbable hydrogel implant incorporating axitinib, a small molecule tyrosine kinase inhibitor with anti-angiogenic properties. The drug is currently being evaluated in Phase I for the treatment of diabetic retinopathy.

Diabetic Retinopathy Pipeline Therapeutics Assessment
There are approx. 50+ key companies which are developing the therapies for Diabetic Retinopathy. The companies which have their Diabetic Retinopathy drug candidates in the mid to advanced stage, i.e. Phase III include, Kodiak Sciences.

Find out more about the Diabetic Retinopathy Pipeline Segmentation, Therapeutics Assessment, Diabetic Retinopathy Emerging Drugs @ Diabetic Retinopathy Treatment Landscape- https://www.delveinsight.com/sample-request/diabetic-retinopathy-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Scope of the Diabetic Retinopathy Pipeline Report

• Coverage- Global

• Diabetic Retinopathy Companies- Novartis, Regenxbio Inc., OcuTerra Therapeutics, Ocular Therapeutix, Bayer, RemeGen, Roche, Ocuphire Pharma, Adverum Biotechnologies, Boehringer Ingelheim, and others.

• Diabetic Retinopathy Pipeline Therapies- KSI-301, Brolucizumab, Runcaciguat, RC 28 E, AKB-9778, RG7774, RGX-314, APX3330, ADVM-022, THR-687, OCX 063, BI 764524, MS-553, NG004, RBM-008, BSL01, PYC001, PMC 403, PL8177, PL9654, LY-09004, CU 06, BNC-1601, APX 1004, UBX 1967, EG-Mirotin, AT 003, FP-008, GLY-230, HLX 04, EYP-1901, and others.

• Diabetic Retinopathy Pipeline Segmentation: Product Type, Molecule Type, Mechanism of Action, Route of Administration

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Table of Content
1. Introduction
2. Executive Summary
3. Diabetic Retinopathy: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Late Stage Products (Phase III)
7. KSI-301: Kodiak Sciences.
8. Drug profiles in the detailed report…..
9. Mid Stage Products (Phase II)
10. RC28-E: RemeGen
11. Drug profiles in the detailed report…..
12. Early Stage Products (Phase I/II)
13. BI 764524: Boehringer Ingelheim
14. Drug profiles in the detailed report…..
15. Inactive Products
16. Diabetic Retinopathy Key Companies
17. Diabetic Retinopathy Key Products
18. Diabetic Retinopathy- Unmet Needs
19. Diabetic Retinopathy- Market Drivers and Barriers
20. Diabetic Retinopathy- Future Perspectives and Conclusion
21. Diabetic Retinopathy Analyst Views
22. Diabetic Retinopathy Key Companies
23. Appendix

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