Wet Age-Related Macular Degeneration Pipeline Insight 2025: Over 60+ Companies Advancing Anti-VEGF, Gene, and Regenerative Therapies to Transform Retinal Disease Treatment | DelveInsight

DelveInsight's "Wet-AMD - Pipeline Insight, 2025" maps a fast-moving landscape for neovascular (wet) age-related macular degeneration, a leading cause of vision loss driven by choroidal neovascularization and exudation. Today's standard of care relies on frequent intravitreal anti-VEGF injections, which are highly effective but create a heavy treatment burden and adherence challenges.

The pipeline is shifting toward durability and disease modification. Next-gen biologics (long-acting antibodies, bispecifics, and high-affinity fragments), small-molecule TKIs in sustained depots, and refillable or long-acting delivery systems aim to extend dosing intervals from monthly to q12-q36 weeks while maintaining fluid control. In parallel, gene therapies (AAV subretinal/suprachoroidal vectors expressing anti-VEGF transgenes) seek one-and-done or few-and-done control of neovascular drive. Select programs are also exploring siRNA, complement-pathway modulators for refractory disease biology, and combination regimens to suppress multiple pro-angiogenic signals. Early regenerative approaches (e.g., RPE-supportive strategies) are being evaluated in niche settings where chronic exudation has damaged the outer retina.

Clinical development increasingly prioritizes patient-centric, durability-first endpoints: best-corrected visual acuity (BCVA), central subfield thickness (CST) on OCT, intraretinal/subretinal fluid resolution, macular neovascular lesion metrics, number of injections over 12-24 months, time to rescue/retreatment, and vision-related patient-reported outcomes. Safety readouts focus on intraocular inflammation, occlusive events, IOP changes, device-related complications, and long-term expression risks in gene therapy.

Regulators are supporting innovation via expedited pathways where appropriate (e.g., Breakthrough/RMAT/Fast Track designations), especially for candidates demonstrating meaningful injection burden reduction with sustained vision outcomes. With maturing readouts across biologics, devices, TKIs, and gene therapy platforms, the wet-AMD therapeutic model is evolving from high-frequency injections toward durable, minimally invasive, and potentially transformational options that can preserve vision and lighten clinic load.

Interested in learning more about the current treatment landscape and the key drivers shaping the Wet Age-Related Macular Degeneration pipeline? Click here: https://www.delveinsight.com/report-store/wet-age-related-macular-degeneration-wet-amd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Wet Age-Related Macular Degeneration Pipeline Report
• DelveInsight's Wet Age-Related Macular Degeneration pipeline analysis depicts a strong space with 60+ active players working to develop 75+ pipeline drugs for Wet Age-Related Macular Degeneration treatment.
• The leading Wet Age-Related Macular Degeneration companies include Outlook Therapeutics, Opthea, Sylentis, Boehringer Ingelheim, Molecular Partners, Sam Chun Dang Pharm, Generium, Alvotech, Adverum Biotechnologies, EyePoint Pharmaceuticals, 4D Molecular Therapeutics, OliX Pharmaceuticals, Kyowa Kirin, Exonate, and others are evaluating their lead assets to improve the Wet Age-Related Macular Degeneration treatment landscape.
• Key Wet Age-Related Macular Degeneration pipeline therapies in various stages of development include ONS-5010, OPT-302, SYL1801, BI 836880, Abicipar pegol, SCD411, GNR-067, AVT06, ADVM-022, EYP-1901, 4D-150, OLX10212, KHK4951, EXN 169, and others.
• In September 2025, Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced that the FDA issued a complete response letter (CRL) for its biologics license application (BLA) resubmission of ONS-5010, an ophthalmic bevacizumab for wet age-related macular degeneration (wet AMD). The CRL cited a single deficiency: insufficient evidence of effectiveness, as ONS-5010 missed the primary endpoint in the NORSE EIGHT trial. The FDA noted that confirmatory efficacy data is needed but acknowledged that the NORSE TWO trial met its primary endpoint.
• In April 2025, Outlook Therapeutics announced that the U.S. FDA has received the resubmitted Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic bevacizumab formulation for treating wet age-related macular degeneration (wet AMD).

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Wet Age-Related Macular Degeneration Overview
Wet Age-Related Macular Degeneration (wet AMD) is a chronic eye condition that primarily affects people over 50 and is a leading cause of vision loss in older adults. It occurs when abnormal blood vessels grow beneath the macula, the central part of the retina responsible for sharp, detailed vision. These vessels can leak fluid or blood, causing rapid damage to the macula and resulting in distorted or loss of central vision.

Early detection and treatment are critical to slowing disease progression and preserving vision. Current therapies focus on inhibiting vascular endothelial growth factor (VEGF), which drives abnormal blood vessel growth. Despite available treatments, wet AMD remains a significant health challenge, highlighting the need for new therapies that offer improved efficacy and longer-lasting vision protection.

Find out more about Wet Age-Related Macular Degeneration medication at https://www.delveinsight.com/report-store/wet-age-related-macular-degeneration-wet-amd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Wet Age-Related Macular Degeneration Treatment Analysis: Drug Profile
RGX-314: REGENXBIO
RGX-314 is a one-time subretinal gene therapy using the NAV AAV8 vector to deliver a gene encoding a monoclonal antibody fragment. This protein aims to neutralize vascular endothelial growth factor (VEGF), thereby preventing the growth of leaky blood vessels and fluid buildup in the retina. RGX-314 is being developed as a potential single-dose treatment for wet AMD, diabetic retinopathy, and other chronic retinal diseases treated with anti-VEGF therapies. REGENXBIO is exploring two delivery methods for RGX-314: a standardized subretinal procedure and administration into the suprachoroidal space. The therapy is currently in Phase III trials for wet AMD.

CLS-AX: Clearside Biomedical
CLS-AX is a proprietary injectable suspension of axitinib, delivered via Clearside's suprachoroidal space (SCS) Microinjector®. Designed as a long-acting treatment for wet AMD, CLS-AX is a potent pan-VEGF tyrosine kinase inhibitor (TKI) that targets delivery behind the retina. This targeted approach may reduce injection frequency while maintaining stable vision. CLS-AX has shown promising safety and efficacy in Phase IIb (ODYSSEY) trials and is progressing toward Phase III development.

SYL1801: Sylentis
SYL1801 is a small interfering RNA (siRNA) currently in non-clinical research. It works through RNA interference (RNAi) to inhibit NRARP (Notch-regulated ankyrin repeat-containing protein), a key player in choroidal neovascularization - the abnormal growth of blood vessels from the choroid into the retina. This process contributes to retinal diseases such as AMD and diabetic retinopathy. NRARP regulates angiogenesis by coordinating the Notch and Wnt signaling pathways to stabilize new endothelial cell connections. SYL1801 is in Phase II development for wet AMD.

Learn more about the novel and emerging Wet Age-Related Macular Degeneration pipeline therapies at https://www.delveinsight.com/report-store/wet-age-related-macular-degeneration-wet-amd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Wet Age-Related Macular Degeneration Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

By Molecule Type
• Monoclonal antibody
• Small molecule
• Peptide

Scope of the Wet Age-Related Macular Degeneration Pipeline Report
• Coverage: Global
• Key Wet Age-Related Macular Degeneration Companies: Outlook Therapeutics, Opthea, Sylentis, Boehringer Ingelheim, Molecular Partners, Sam Chun Dang Pharm, Generium, Alvotech, Adverum Biotechnologies, EyePoint Pharmaceuticals, 4D Molecular Therapeutics, OliX Pharmaceuticals, Kyowa Kirin, Exonate, and others.
• Key Wet Age-Related Macular Degeneration Pipeline Therapies: ONS-5010, OPT-302, SYL1801, BI 836880, Abicipar pegol, SCD411, GNR-067, AVT06, ADVM-022, EYP-1901, 4D-150, OLX10212, KHK4951, EXN 169, and others.

To dive deep into rich insights for drugs used for Wet Age-Related Macular Degeneration treatment, visit: https://www.delveinsight.com/report-store/wet-age-related-macular-degeneration-wet-amd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Wet Age-Related Macular Degeneration Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Wet Age-Related Macular Degeneration Pipeline Therapeutics
6. Wet Age-Related Macular Degeneration Pipeline: Late-Stage Products (Phase III)
7. Wet Age-Related Macular Degeneration Pipeline: Mid-Stage Products (Phase II)
8. Wet Age-Related Macular Degeneration Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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This release was published on openPR.