In August 2025, Outlook Therapeutics announced a regulatory update that drew significant attention in the Wet Age-Related Macular Degeneration market. The FDA issued a Complete Response Letter (CRL) to the company’s biologics license application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg), citing a lack of substantial evidence of effectiveness. While this outcome delays the introduction of what could have been the first on-label bevacizumab product specifically formulated for Wet AMD in the U.S., it simultaneously highlights both the opportunities and challenges shaping the Wet AMD treatment landscape.

Interestingly, while the FDA setback paused U.S. entry, ONS-5010 has already made its mark in Europe and the UK, with approvals by the European Commission and MHRA earlier this year. The therapy became commercially available in Germany and the UK in June 2025, positioning itself as the first and only authorized ophthalmic formulation of bevacizumab for Wet AMD in these markets. This divergence between U.S. and European regulatory pathways underscores the evolving dynamics of the Wet AMD market landscape and how regulatory decisions can steer competitive strategies.

Against this backdrop, DelveInsight’s latest Wet Age-Related Macular Degeneration (Wet AMD) – Market Insight, Epidemiology, and Market Forecast – 2034 report provides a deep dive into the Wet AMD market, examining epidemiology trends, current treatment practices, and the robust pipeline of therapies that aim to reshape patient outcomes. With the Wet AMD market size reaching USD 7.7 billion in 2023 across the 7MM and poised for further growth, stakeholders are navigating a critical phase defined by innovation, competition, and shifting regulatory expectations.

Key Insights into the Wet Age-Related Macular Degeneration Market

• The Wet Age-Related Macular Degeneration market size across the 7MM was valued at USD 7.7 billion in 2023 and is expected to witness steady growth through 2034.

• In 2024, the 7MM had approximately 70 million prevalent cases of AMD.

• In the US, wet AMD affected around 95.5K (≤64 yrs), 405K (65–84 yrs), and 473.5K (85+ yrs).

• Late-stage AMD (nAMD + GA) accounted for about 5.69 million cases in the 7MM.

• Among the currently approved Wet AMD therapies, EYLEA (aflibercept) dominated the Wet AMD market in 2023 with revenues of approximately USD 4.2 billion, followed by Lucentis (ranibizumab), Beovu (brolucizumab), and off-label Avastin (bevacizumab).

• In August 2025, the FDA issued a Complete Response Letter (CRL) to Outlook Therapeutics’ ONS-5010/LYTENAVA™, citing a lack of confirmatory evidence of efficacy. Despite this, the therapy has already gained Marketing Authorization in the EU and UK, where it launched commercially in June 2025. This marks a pivotal moment for the Wet AMD treatment landscape, creating different regulatory and competitive dynamics across regions.

• In April 2025, Outlook Therapeutics announced that the FDA 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).

• Several promising Wet AMD pipeline therapies are under development, including OPT-302 (Opthea Limited), KSI-501 (Kodiak Sciences Inc.), and others, which aim to address unmet needs such as treatment durability and efficacy in non-responders.

• A diverse pool of players, including Opthea Limited, Outlook Therapeutics, Kodiak Sciences, Regenxbio, Dobecure, Gemini Therapeutics, Huabo Biopharm, Isarna Therapeutics, IVERIC bio, and Bio-Thera Solutions, are actively contributing to the innovation within the Wet AMD market landscape.

• Despite advances, challenges persist in the Wet AMD treatment landscape, such as the need for frequent intravitreal injections, high treatment costs, and disparities in patient access, particularly in aging populations.

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Wet Age-Related Macular Degeneration Overview

Wet Age-Related Macular Degeneration (Wet AMD) is a progressive eye disorder and one of the leading causes of severe vision loss in older adults worldwide. Unlike the dry form of AMD, Wet AMD is characterized by the abnormal growth of blood vessels beneath the retina, which leak fluid or blood, leading to rapid and often irreversible central vision impairment. With the global population aging at an unprecedented pace, the burden of Wet AMD treatments has become a critical public health and economic challenge.

The Wet Age-Related Macular Degeneration market is driven by the high prevalence of the disease and the urgent need for effective Wet AMD therapies. Current Wet AMD treatments primarily involve anti-VEGF agents, which have transformed patient outcomes but also require frequent intravitreal injections, placing a significant burden on patients, caregivers, and healthcare systems. Despite therapies like EYLEA, Lucentis, and Beovu offering clinical benefits, unmet needs persist in terms of durability, cost-effectiveness, and efficacy for patients who show suboptimal responses.

The evolving Wet AMD therapeutic landscape is marked by innovation, competition, and regulatory decisions that can alter market dynamics. The recent setback for Outlook Therapeutics’ ONS-5010 in the U.S., juxtaposed with its successful European and UK launches, demonstrates the complexities of advancing novel Wet AMD therapies globally. For stakeholders, this creates both risks and opportunities, as the future of the Wet AMD market landscape will depend on how emerging drugs address these gaps while navigating regulatory pathways.

Get a free sample for the Wet Age-Related Macular Degeneration market forecast, size & share analysis report: https://www.delveinsight.com/report-store/wet-age-related-macular-degeneration-wet-amd-market

Wet Age-Related Macular Degeneration Epidemiology

The epidemiology section offers an overview of historical, current, and projected trends in the seven major markets (7MM) from 2020 to 2034. It helps identify the factors influencing these trends by examining various studies and perspectives from key opinion leaders. Additionally, the section provides an in-depth analysis of the diagnosed patient population and future trends.

Wet Age-Related Macular Degeneration Epidemiology Segmentation:

The Wet Age-Related Macular Degeneration market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:

• Total Prevalent Cases Of Age-Related Macular Degeneration

• Diagnosed Prevalent Cases Of Age-Related Macular Degeneration

• Type-Specific Diagnosed Prevalent Cases Of Age-Related Macular Degeneration

• Total Age-Specific Cases Of Wet-AMD

Drugs Uptake & Pipeline Development Activities in Wet Age-Related Macular Degeneration

The Wet Age-Related Macular Degeneration market landscape is witnessing an era of innovation, with novel gene therapies, oral drugs, and biologics poised to reshape treatment standards. While anti-VEGF agents like EYLEA, Lucentis, and Beovu dominate the current Wet AMD treatment landscape, challenges such as frequent injections and variable patient response continue to create room for next-generation solutions.

The Drug Uptake analysis in DelveInsight’s report provides a comprehensive evaluation of the adoption trends of newly launched and upcoming Wet AMD therapies, assessing patient acceptance, market penetration, and commercial performance. It highlights the drivers behind rapid uptake, compares market shares, and identifies therapies gaining meaningful traction.

Ixoberogene soroparvovec (Ixo-vec): Adverum Biotechnologies

A Phase III gene therapy, designed to deliver aflibercept through an in-office procedure, aiming for long-term VEGF suppression. Backed by Fast Track, RMAT, and PRIME designations, Ixo-vec could provide a durable and cost-effective alternative in the Wet AMD market.

RGX-314: Regenxbio

A one-time subretinal gene therapy currently in Phase III and II/III trials, RGX-314 targets VEGF-driven neovascularization. With a global filing anticipated in 2026, it has strong potential to transform the Wet AMD therapeutic landscape.

AKST4290: Alkahest

An oral CCR3 inhibitor, offering a distinct mechanism by blocking eotaxin pathways linked to inflammation and neovascularization. Completed Phase IIa trials suggest promise for both naïve and refractory patients, positioning it as a differentiated option in the Wet AMD pipeline.

Beyond these, the pipeline is diverse, featuring programs from Opthea, Outlook Therapeutics, Kodiak Sciences, and others, reflecting the competitive intensity of the Wet AMD market. In addition to clinical progress, the report also tracks partnerships, licensing, and strategic deals, which continue to shape the future direction of the Wet Age-Related Macular Degeneration market.

Explore how emerging Wet Age-Related Macular Degeneration therapies are aligning with evolving patient populations

Wet Age-Related Macular Degeneration Market Outlook

Over the past two decades, the Wet Age-Related Macular Degeneration market has witnessed a remarkable transformation. What began with photodynamic therapy gradually gave way to anti-VEGF treatments such as MACUGEN, off-label AVASTIN, and eventually LUCENTIS, EYLEA, BEOVU, VABYSMO, and SUSVIMO. These therapies have significantly improved patient outcomes by stabilizing or even restoring vision, yet challenges remain in durability, treatment burden, and the fact that up to 30% of patients show limited response. According to DelveInsight’s estimates, the Wet AMD market size across the 7MM stood at USD 7.7 billion in 2023, with strong growth anticipated through 2034, driven by evolving treatment paradigms, pipeline innovation, and biosimilar competition.

The competitive environment is shifting rapidly as patent expiries for LUCENTIS (2020) and EYLEA (2023) open the door for biosimilars to reshape the Wet AMD treatment landscape. Affordable alternatives such as Samsung Bioepis’ OPUVIZ and Biocon’s YESAFILI, both approved as interchangeable biosimilars to EYLEA in May 2024, are already altering market dynamics and reducing the economic burden for patients. Meanwhile, Roche has introduced SUSVIMO, and Samsung Bioepis launched BYOOVIZ in an attempt to reclaim market share. Despite these advances, bevacizumab continues to hold nearly 50% of the U.S. Wet AMD market due to its low cost, though safety concerns related to compounding persist.

The next decade is expected to be defined by innovation from late-stage pipelines, including Adverum’s ixoberogene soroparvovec (Ixo-vec) and Kodiak’s KSI-301, both designed to reduce treatment frequency and improve efficacy. However, the recent regulatory setback for Outlook Therapeutics highlights the uncertainty that accompanies such innovation.

On August 28, 2025, the FDA issued a Complete Response Letter for ONS-5010/LYTENAVA, citing insufficient evidence of efficacy despite strong results in earlier trials. While disappointing in the U.S., the therapy has already received Marketing Authorization in the EU and UK, with commercial launches in Germany and the UK in 2025. This contrast highlights the complexities of global regulatory pathways, while also reflecting the resilience of the Wet AMD market and the ongoing push toward safer, more effective, and durable therapies.

Scope of the Wet Age-Related Macular Degeneration Market Report

• Study Period: 2020–2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan].

• Key Wet Age-Related Macular Degeneration Companies: Opthea Limited, Outlook Therapeutics, Kodiak Sciences, Regenxbio, Dobecure, Gemini Therapeutics, Huabo Biopharm, Isarna Therapeutics, IVERIC bio, Bio-Thera Solutions, and others.

• Key Wet Age-Related Macular Degeneration Therapies: OPT-302 (Opthea Limited), KSI-501 (Kodiak Sciences Inc.), and others.

• Wet Age-Related Macular Degeneration Therapeutic Assessment: Wet Age-Related Macular Degeneration currently marketed, and Wet Age-Related Macular Degeneration emerging therapies.

• Wet Age-Related Macular Degeneration Market Dynamics: Wet Age-Related Macular Degeneration market drivers and Wet Age-Related Macular Degeneration market barriers.

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies.

• Wet Age-Related Macular Degeneration Unmet Needs, KOL’s views, Analyst’s views, Wet Age-Related Macular Degeneration Market Access and Reimbursement.

To learn more about Wet Age-Related Macular Degeneration companies working in the treatment market, check out our Wet Age-Related Macular Degeneration Market Report.

Table of Contents

1. Wet Age-Related Macular Degeneration Market Report Introduction

2. Executive Summary for Wet Age-Related Macular Degeneration

3. SWOT analysis of Wet Age-Related Macular Degeneration

4. Wet Age-Related Macular Degeneration Patient Share (%) Overview at a Glance

5. Wet Age-Related Macular Degeneration Market Overview at a Glance

6. Wet Age-Related Macular Degeneration Disease Background and Overview

7. Wet Age-Related Macular Degeneration Epidemiology and Patient Population

8. Country-Specific Patient Population of Wet Age-Related Macular Degeneration

9. Wet Age-Related Macular Degeneration Current Treatment and Medical Practices

10. Wet Age-Related Macular Degeneration Unmet Needs

11. Wet Age-Related Macular Degeneration Emerging Therapies

12. Wet Age-Related Macular Degeneration Market Outlook

13. Country-Wise Wet Age-Related Macular Degeneration Market Analysis (2020–2034)

14. Wet Age-Related Macular Degeneration Market Access and Reimbursement of Therapies

15. Wet Age-Related Macular Degeneration Market Drivers

16. Wet Age-Related Macular Degeneration Market Barriers

17. Wet Age-Related Macular Degeneration Appendix

18. Wet Age-Related Macular Degeneration Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

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