Wet AMD Clinical Trials Pipeline Analysis Featuring 70+ Key Companies by DelveInsight

DelveInsight's, "Wet Age-Related Macular Degeneration Pipeline Insight, 2022," report provides comprehensive insights about 70+ companies and 80+ pipeline drugs in Wet Age-Related Macular Degeneration (Wet-AMD) pipeline landscape. It covers the Wet Age-Related Macular Degeneration pipeline drug profiles, including Wet Age-Related Macular Degeneration clinical trials and nonclinical stage products. It also covers the 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 Wet Age-Related Macular Degeneration Pipeline Report

• DelveInsight's Wet AMD pipeline analysis depicts a robust space with 70+ active players working to develop 80+ pipeline therapies.
• Some of the key pharmaceutical players working to develop potential Wet AMD drug candidates to improve the Wet AMD treatment landscape include Opthea Limited, Outlook Therapeutics, Kodiak Sciences, Regenxbio, Dobecure, Gemini Therapeutics, Huabo Biopharm, Isarna Therapeutics, IVERIC bio (formerly Ophthotech Corporation), Ribomic, Curacle, Bio-Thera Solutions, AngioLab Inc, Alkahest, Tyrogenex, Iconic Therapeutics, AiViva BioPharma, Boehringer Ingelheim, RemeGen, PanOptica, Clearside Biomedical, Feramda, AsclepiX Therapeutics, Unity Biotechnology, Kyowa Kirin, Ocular Therapeutix, Janssen Research & Development, EyePoint Pharmaceuticals, Shanghai Biomabs Pharmaceutical, Aerie Pharmaceuticals, Ashvattha Therapeutics, Roche, Sunshine Guojian Pharmaceutical (Shanghai), Adverum Biotechnologies, TOT Biopharm, 4D Molecular Therapeutics, Abpro Corporation, Novelty Nobility, Kala Pharmaceuticals, Surrozen, Eyevensys, Ocugen, Exonate, and others.
• Key Wet AMD pipeline therapies in various stages of development include OPT-302, ONS-5010, KSI-301, RGX-314, Etamsylate, GEM-103, HB002.1M, ISTH0036, Zimura, RBM-007, CU03, PF-04523655, BAT5906, ALS-L1023, AKST4290, Vorolanib (X-82), ICON-1, AIV007, BI 836880, RC 28 E, PAN 90806, CLS-AX, AS101, AXT107, UBX1325, KHK4951, OTX-TKI, AAVCAGsCD59, EYP-1901, CMAB818, AR-13503, D-4517, RG6120, 601A, ADVM-022, TAB014, 4D-150, ABP-201, NN2101, EYS609, OCU 200, EXN 169, and others.
• The Wet AMD companies and academics that are working to assess challenges and seek opportunities that could influence Wet Age-Related Macular Degeneration (Wet-AMD) R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.

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Wet Age-Related Macular Degeneration Overview

Age-related macular degeneration (AMD) is a multifactorial ocular disease that affects the maculae due to late-onset progressive neurodegeneration and dysfunction of photoreceptors and retinal pigment epithelium (RPE). Majorly, there are two types of AMD: dry (atrophic) and wet (neovascular or exudative). Most AMD starts as the dry type, and in 10-20% of individuals, it progresses to the wet type. Wet AMD is less common but more severe than the dry type. The wet/neovascular type affects approximately 10-15% of individuals with age-related macular degeneration but accounts for approximately 90% of all cases of severe vision loss from the disease. It causes 90% of severe vision loss in people with AMD. Everyone who gets wet AMD had dry AMD at one point. Wet AMD, also known as neovascular AMD or exudative AMD, is a form of retinal degeneration in which abnormal choroidal neovascularization occurs under the retina and macula lutea. Because these new blood vessels are abnormal, they tend to break, bleed, and leak fluid, damaging the macula and causing it to lift up and pull away from its base. This can result in a rapid and severe loss of central vision.

Recent Developmental Activities in the Wet Age-Related Macular Degeneration Treatment Landscape

• In August 2022, Opthea Limited announced a non-dilutive financing transaction for up to US$170 million from investment funds working with Launch Therapeutics (Launch Tx) to finance and advance the ongoing Phase 3 clinical trials and pre-commercialization activities of OPT-302 for wet age-related macular degeneration (wet AMD).
• In August 2022, Outlook Therapeutics, Inc. announced that it had re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic therapy which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).
• In August 2022, EyePoint Pharmaceuticals, Inc. announced that the first patient had been dosed in Phase 2 "Durasert® and Vorolanib in Ophthalmology 2" (DAVIO 2) clinical trial of EYP-1901, an investigational sustained delivery anti-vascular endothelial growth factor (anti-VEGF) treatment for wet age-related macular degeneration (wet AMD).
• In August 2022, Alcon and Aerie Pharmaceuticals, Inc. announced the companies had entered into a definitive merger agreement through which Alcon would acquire Aerie.
• In July 2022, REGENXBIO Inc. announced it had completed enrollment in Cohort 5 of the Phase II AAVIATE® trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using in-office suprachoroidal delivery.
• In July 2022, IVERIC bio, Inc. and DelSiTech Ltd, announced an exclusive global license agreement providing Iveric Bio with the right to develop and commercialize new formulations of Zimura® (avacincaptad pegol) using DelSiTech's silica-based sustained release technology. As part of Iveric Bio's lifecycle expansion plan for Zimura, the Company is committed to developing sustained release technologies for the treatment of age-related macular degeneration (AMD). These technologies could potentially address patients being treated for geographic atrophy (GA) and intermediate AMD.
• In July 2022, Clearside Biomedical, Inc. announced the completion of dosing in Cohorts 3 and 4 of OASIS, its Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) in patients with neovascular age-related macular degeneration (wet AMD).
• In March 2022, RIBOMIC Inc. announced the results from the investigator-sponsored trial (IST), TEMPURA, along with updated data from its TOFU and RAMEN studies with RBM-007, an investigational anti-fibroblast growth factor-2 aptamer, in wet age-related macular degeneration (wAMD).Early signs of efficacy in the TEMPURA study provide initial support of clinical benefit in treatment-naïve wAMD. Further analysis of Phase 2 TOFU data and results from the RAMEN study in previously treated wAMD show no benefit of RBM-007 monotherapy or the combination over Eylea in any of the study outcome measures. The new data suggests RBM-007 could be more effective in treatment-naïve vs previously treated wAMD.
• In December 2021, Gemini Therapeutics received six-month data for the 50 patients enrolled in the wet AMD study. This study was designed to investigate the safety and tolerability of GEM103 as an adjunct to standard of care aflibercept therapy, with patients randomized 2:1 between a GEM103 plus aflibercept arm and a sham comparator plus aflibercept arm. The interim analysis showed that intravitreal GEM103 plus aflibercept was generally well-tolerated, and the safety profile was generally consistent with the sham plus aflibercept arm. Patients in this study were dosed every other month concurrently with aflibercept. CFH levels remained supraphysiologic and greater than five times above baseline at the trough time points throughout the six months.

Wet Age-Related Macular Degeneration Emerging Drugs

LY09004: Luye Pharma
LY09004, a biosimilar for Eylea, is a recombinant human vascular endothelial growth factor receptor-antibody fusion protein ophthalmic injection, indicated for neovascular wAMD, macular edema following RVO, DME and diabetic retinopathy (DR) in patients with DME, and visual impairment due to pathological myopia secondary to choroidal neovascularization (PM-CNV). It is currently in the Phase III stage of development for the treatment of wAMD and is being developed by Luye Pharma.

KSI-301: Kodiak Sciences
KSI-301 is a novel anti-VEGF biologic built on a propriety antibody biopolymer conjugate (ABC) platform. KSI-301 is administered as an intravitreal injection and designed to provide sustained inhibition of VEGF for up to 6 months. The unique properties of KSI- 301 aim to provide patients with long-term control of their wet AMD with improved vision outcomes while reducing the burden of frequent anti-VEGF injections. It is currently in the Phase III stage of development for the treatment of wAMD and is being developed by Kodiak Sciences.

GEM-103: Gemini Therapeutics
GEM103 is a full-length recombinant complement factor H (rCFH) protein, is believed to be the first ever recombinant native complement regulator. GEM103 delivered by intravitreal injection is designed to address both complement hyperactivity and restore retinal health in patients with AMD. It is currently in the Phase II stage of development for the treatment of wAMD and is being developed by Gemini Therapeutics.

Zimura: Iveric Bio
Zimura (avacincaptad pegol) is designed to inhibit complement factor C5 cleavage into C5a and C5b. By inhibiting the formation of complement C5 terminal fragments, Zimura may decrease the activation of inflammasomes and the formation of membrane attack complex (MAC). The drug is in Phase III clinical studies for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD) and in Phase II clinical studies for wet AMD, Stargardt disease, and polypoidal choroidal vasculopathy (PCV).

RC 28 E: RemeGen
RC 28 E is a chimeric decoy receptor trap-fusion protein that acts by dual blockade of vascular endothelial growth factor (VEGF) and fibroblast growth factor-2. As compared to single-target EGF inhibitors, RC 28 has the potential to more effectively inhibit the abnormal blood vessel growth implicated in various diseases through both VEGF and FGF pathways, potentially allowing for a better dosing profile.

BI 836880: Boehringer Ingelheim
BI 836880 is a humanized bispecific nanobody comprising blocking domains for VEGF and angiopoietin-2 (Ang2). BI 836880 is a potent and selective inhibitor of VEGF and Ang2. By binding to VEGF and Ang2, BI 836880 inhibits tumor angiogenesis and vascularization and enhances the tumor microenvironment to support T-cell trafficking and function in the tumor. BI 836880 is currently being investigated in Phase II clinical studies for solid tumors and in Phase I clinical studies to treat wet AMD and non-small cell lung cancer.

AAVCAGsCD59: Janssen Research and Development
AAVCAGsCD59 is gene therapy. This drug is currently being evaluated in FDA approved clinical trials to treat both dry and wAMD. HMR59 injected in the eye increases the ability of retina cells to make a soluble form of CD59 called sCD59. The soluble CD59 circulates within the retina to block complement from further damaging the retina. AAVCAGsCD59 is currently in the Phase I stage of development for the treatment of wAMD and is being developed by Janssen Research and Development.

Wet Age-Related Macular Degeneration Therapeutic Assessment
There are approx. 70+ key companies which are developing the therapies for Wet Age-Related Macular Degeneration (Wet-AMD). The companies which have their Wet Age-Related Macular Degeneration (Wet-AMD) drug candidates in the most advanced stage, i.e. phase III include, Luye Pharma.

Find out more about the disease and recent developments in the Wet AMD Treatment Drugs @ https://www.delveinsight.com/report-store/wet-age-related-macular-degeneration-wet-amd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Scope of the Wet Age-Related Macular Degeneration Pipeline Report

• Coverage: Global
• Wet AMD Companies- Opthea Limited, Outlook Therapeutics, Kodiak Sciences, Regenxbio, Dobecure, Gemini Therapeutics, Huabo Biopharm, Isarna Therapeutics, IVERIC bio (formerly Ophthotech Corporation), Ribomic, Curacle, Bio-Thera Solutions, AngioLab Inc, Alkahest, Tyrogenex, Iconic Therapeutics, AiViva BioPharma, Boehringer Ingelheim, RemeGen, PanOptica, Clearside Biomedical, Feramda, AsclepiX Therapeutics, Unity Biotechnology, Kyowa Kirin, Ocular Therapeutix, Janssen Research & Development, EyePoint Pharmaceuticals, Shanghai Biomabs Pharmaceutical, Aerie Pharmaceuticals, Ashvattha Therapeutics, Roche, Sunshine Guojian Pharmaceutical (Shanghai), Adverum Biotechnologies, TOT Biopharm, 4D Molecular Therapeutics, Abpro Corporation, Novelty Nobility, Kala Pharmaceuticals, Surrozen, Eyevensys, Ocugen, Exonate, and others.
• Wet AMD Pipeline Therapies- OPT-302, ONS-5010, KSI-301, RGX-314, Etamsylate, GEM-103, HB002.1M, ISTH0036, Zimura, RBM-007, CU03, PF-04523655, BAT5906, ALS-L1023, AKST4290, Vorolanib (X-82), ICON-1, AIV007, BI 836880, RC 28 E, PAN 90806, CLS-AX, AS101, AXT107, UBX1325, KHK4951, OTX-TKI, AAVCAGsCD59, EYP-1901, CMAB818, AR-13503, D-4517, RG6120, 601A, ADVM-022, TAB014, 4D-150, ABP-201, NN2101, EYS609, OCU 200, EXN 169, and others.

Table of content
1. Introduction
2. Wet Age-Related Macular Degeneration Executive Summary
3. Wet Age-Related Macular Degeneration (Wet-AMD): Overview
4. Wet Age-Related Macular Degeneration Pipeline Therapeutics
5. Wet Age-Related Macular Degeneration Therapeutic Assessment
6. Wet Age-Related Macular Degeneration (Wet-AMD) - DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. LY09004: Luye Pharma
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. GEM-103: Gemini Therapeutics
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. BI 836880: Boehringer Ingelheim
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. EYS609: Eyevensys
18. Drug profiles in the detailed report…..
19. Inactive Products
20. Wet Age-Related Macular Degeneration Key Companies
21. Wet Age-Related Macular Degeneration Key Products
22. Wet Age-Related Macular Degeneration Unmet Needs
23. Wet Age-Related Macular Degeneration Market Drivers
24. Wet Age-Related Macular Degeneration Market Barriers
25. Wet Age-Related Macular Degeneration Future Perspectives and Conclusion
26. Wet Age-Related Macular Degeneration Analyst Views
27. Wet Age-Related Macular Degeneration Key Companies
28. Appendix

Key Questions
Current Treatment Scenario and Emerging Therapies:
• How many companies are developing Wet Age-Related Macular Degeneration (Wet-AMD) drugs?
• How many Wet Age-Related Macular Degeneration (Wet-AMD) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Wet Age-Related Macular Degeneration (Wet-AMD)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Wet Age-Related Macular Degeneration (Wet-AMD) therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Wet Age-Related Macular Degeneration (Wet-AMD) and their status?
• What are the key designations that have been granted to the emerging drugs?

For further information on Wet AMD pipeline therapeutics, reach out for Wet AMD Drugs @ https://www.delveinsight.com/report-store/wet-age-related-macular-degeneration-wet-amd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

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