DelveInsight’s, “Wet Age-Related Macular Degeneration (Wet-AMD) Pipeline Insight 2023,” report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Wet Age-Related Macular Degeneration (Wet-AMD) pipeline landscape. It covers the pipeline drug profiles, including clinical 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
- Over 75+ Wet Age-Related Macular Degeneration companies are evaluating 80+ Wet Age-Related Macular Degeneration therapies in various stages of development, and their anticipated acceptance in the Wet Age-Related Macular Degeneration market would significantly increase market revenue.
- The leading Wet Age-Related Macular Degeneration Companies include Molecular Partners, Sandoz, Sam Chun Dang Pharm, Samsung Bioepis, Opthea Limited, Shandong Boan Biotechnology Co. Ltd., Shanghai Henlius Biotech, Adverum Biotechnologies, Alkahest, Tyrogenex, Tasly Pharmaceutical Group, Ribomic, Innovent Biologics, GrayBug Vision, PanOptica, AsclepiX Therapeutics, AiViva BioPharma, RemeGen, Boehringer Ingelheim, Roche, Sunshine Guojian Pharmaceutical (Shanghai), Kyowa Kirin, Ocular Therapeutix, Shanghai Biomabs Pharmaceutical, Samjin Pharm, AffaMed Therapeutics, Novelty Nobility, Surrozen, Akari Therapeutics, Eyevensys, PharmAbcine, Evergreen Therapeutics, Ingenia Therapeutics, Ikarovec, Valitor, Character Biosciences, and others.
- Promising Wet Age-Related Macular Degeneration Pipeline Therapies 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 Age-Related Macular Degeneration 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 Wet Age-Related Macular Degeneration pipeline 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. The dry (atrophic) type affects approximately 80–90% of individuals with AMD.
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.
For further information, refer to the detailed Wet Age-Related Macular Degeneration Drugs Launch, Wet Age-Related Macular Degeneration Developmental Activities, and Wet Age-Related Macular Degeneration News, click here for Wet Age-Related Macular Degeneration Ongoing Clinical Trial Analysis
Abicipar pegol: Molecular Partners
Abicipar pegol is a long-acting anti-VEGF therapeutic candidate, which was invented by Molecular Partners and initially licensed to Allergan in 2011. The program has been through two positive Phase III studies, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the Abicipar quarterly dosing regimen to maintain vision gains with more than 50 percent fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year. In June 2020, a Complete Response Letter was issued for the Biologics License Application for Abicipar pegol, indicating that the rate of intraocular inflammation observed following administration of Abicipar pegol resulted in an unfavorable benefit-risk ratio in the treatment of nAMD (AMD), and that additional work would be required to demonstrate a lower rate of ocular inflammation than what was previously seen in the Phase III studies. In 2021, Molecular Partners regained global rights to Abicipar from AbbVie and is determining appropriate next steps for the program.
SOK583A1: Sandoz
Aflibercept binds and inhibits ocular VEGF-A and prevents abnormal growth of blood vessels in the choroid, impacting visual function. It improves visual acuity in patients with neovascular retinal diseases like nAMD, DME, and RVO. SOK583A1 is a biosimilar of Aflibercept (Eylea). It is currently in the Phase III stage of development for the treatment of wAMD and is being developed by Sandoz.
BA9101 (LY09004): Shandong Boan Biotechnology Co. Ltd.
BA9101 (LY09004), a biosimilar for Eylea, is a recombinant human vascular endothelial growth factor receptor-antibody fusion protein ophthalmic injection, indicated for neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR) in patients with diabetic macular edema, and visual impairment due to pathological myopia secondary to choroidal neovascularization(PM-CNV). As a soluble decoy receptor, LY09004 can bind to cytokines such as VEGF-A, VEGF-B and P1GF, inhibit the downstream signaling pathway of VEGFR, inhibit neovascularization, and reduce vascular permeability, thereby treating pathological neovascularization of the retina and choroid eye diseases.
ADVM-022: Adverum Biotechnologies
ADVM-022 is a recombinant, replication-deficient adeno virus-associated (AAV) gene therapy. ADVM-022 utilizes a propriety vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. ADVM-022 (AAV.7m8-aflibercept) is administered as a single, in-office intravitreal (IVT) injection, designed to deliver long-term efficacy and reduce the burden of frequent anti-VEGF injections, optimize patient compliance and improve vision outcomes for patients with wet AMD and DME. The therapeutic candidate is in Phase II clinical studies for wet AMD.
Wet Age-Related Macular Degeneration Pipeline Therapeutics Assessment
There are approx. 75+ key companies which are developing the therapies for Wet Age-related Macular Degeneration. The companies which have their Wet Age-related Macular Degeneration drug candidates in the most advanced stage, i.e. Preregistration include, Molecular Partners.
Find out more about the Wet Age-Related Macular Degeneration Pipeline Segmentation, Therapeutics Assessment, and Wet Age-Related Macular Degeneration Emerging Drugs @ Wet Age-Related Macular Degeneration Treatment Landscape
Scope of the Wet Age-Related Macular Degeneration Pipeline Report
- Coverage- Global
- Wet Age-Related Macular Degeneration Companies – Molecular Partners, Sandoz, Sam Chun Dang Pharm, Samsung Bioepis, Opthea Limited, Shandong Boan Biotechnology Co. Ltd., Shanghai Henlius Biotech, Adverum Biotechnologies, Alkahest, Tyrogenex, Tasly Pharmaceutical Group, Ribomic, Innovent Biologics, GrayBug Vision, PanOptica, AsclepiX Therapeutics, AiViva BioPharma, RemeGen, Boehringer Ingelheim, Roche, Sunshine Guojian Pharmaceutical (Shanghai), Kyowa Kirin, Ocular Therapeutix, Shanghai Biomabs Pharmaceutical, Samjin Pharm, AffaMed Therapeutics, Novelty Nobility, Surrozen, Akari Therapeutics, Eyevensys, PharmAbcine, Evergreen Therapeutics, Ingenia Therapeutics, Ikarovec, Valitor, Character Biosciences, and others.
- Wet Age-Related Macular Degeneration 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.
- Wet Age-Related Macular Degeneration Segmentation: Phases, Molecule Type, Mechanism of Action, Route of Administration
Dive deep into rich insights for drugs for Wet Age-Related Macular Degeneration Pipeline Companies and Therapies, click here @ Wet Age-Related Macular Degeneration Unmet Needs and Analyst Views
Table of Content
- Introduction
- Executive Summary
- Wet Age-Related Macular Degeneration (Wet-AMD): Overview
- Wet Age-Related Macular Degeneration Pipeline Therapeutics
- Wet Age-Related Macular Degeneration Therapeutic Assessment
- Wet Age-Related Macular Degeneration (Wet-AMD) – DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- LY09004: Luye Pharma
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- GEM-103: Gemini Therapeutics
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- BI 836880: Boehringer Ingelheim
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- EYS609: Eyevensys
- Drug profiles in the detailed report…..
- Inactive Products
- Wet Age-Related Macular Degeneration (Wet-AMD) Key Companies
- Wet Age-Related Macular Degeneration (Wet-AMD) Key Products
- Wet Age-Related Macular Degeneration (Wet-AMD)- Unmet Needs
- Wet Age-Related Macular Degeneration (Wet-AMD)- Market Drivers and Barriers
- Wet Age-Related Macular Degeneration (Wet-AMD)- Future Perspectives and Conclusion
- Wet Age-Related Macular Degeneration (Wet-AMD) Analyst Views
- Wet Age-Related Macular Degeneration (Wet-AMD) Key Companies
- Appendix
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