Press release
Wet Age-Related Macular Degeneration Market Forecast to 2034: Outlook Therapeutics' FDA Setback and the Future of Therapies | DelveInsight
DelveInsight's "Wet AMD - Market Insight 2034" covers the 7MM market with key players like Opthea, Outlook, Kodiak, Regenxbio, and IVERIC bio, highlighting emerging therapies and growing patient demand, while sparking curiosity about which next-generation treatment could redefine Wet AMD care.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 [https://www.delveinsight.com/report-store/wet-age-related-macular-degeneration-wet-amd-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr] 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 ( less than or equal to 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 Trademark , 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.
Request a sample and uncover the latest breakthroughs shaping the Wet Age-Related Macular Degeneration market landscape and future outlook [https://www.delveinsight.com/report-store/wet-age-related-macular-degeneration-wet-amd-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr].
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 [https://www.delveinsight.com/report-store/wet-age-related-macular-degeneration-wet-amd-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr]
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 naive 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 [https://www.delveinsight.com/report-store/wet-age-related-macular-degeneration-wet-amd-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr] 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 [https://www.delveinsight.com/report-store/wet-age-related-macular-degeneration-wet-amd-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr].
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
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve.
Media Contact
Company Name: DelveInsight
Contact Person: Jatin Vimal
Email:Send Email [https://www.abnewswire.com/email_contact_us.php?pr=wet-agerelated-macular-degeneration-market-forecast-to-2034-outlook-therapeutics-fda-setback-and-the-future-of-therapies-delveinsight]
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/
Legal Disclaimer: Information contained on this page is provided by an independent third-party content provider. ABNewswire makes no warranties or responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you are affiliated with this article or have any complaints or copyright issues related to this article and would like it to be removed, please contact retract@swscontact.com
This release was published on openPR.
Permanent link to this press release:
Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.
You can edit or delete your press release Wet Age-Related Macular Degeneration Market Forecast to 2034: Outlook Therapeutics' FDA Setback and the Future of Therapies | DelveInsight here
News-ID: 4168795 • Views: …
More Releases from ABNewswire

Non-Cystic Fibrosis Bronchiectasis Market Outlook 2034 - Clinical Trials, Market …
Non-Cystic Fibrosis Bronchiectasis companies working in the market are Insmed, AstraZeneca, Zambion, The Marcus Foundation, Inc., Chiesi Farmaceutici S.p.A., SolAeroMed Inc., Zambon SpA, Boehringer Ingelheim, Renovion, Inc., Novartis, Alaxia SAS, and others.
Non-Cystic Fibrosis Bronchiectasis Market Summary
The NCFB market in the 7MM was valued at ~USD 1,455 million in 2023 and is projected to expand at a CAGR of 14.5% (2024-2034), driven by innovative therapies such as brensocatib and CMS I-neb,…

Chronic Kidney Disease Market Outlook 2034 - Clinical Trials, Market Size, Medic …
Key Chronic Kidney Disease Companies are ProKidney, Reata Pharmaceuticals, Inc., Novo Nordisk A/S, Boehringer Ingelheim, Eli Lilly and Company, KBP Biosciences, Kibow Pharma, Cincor Pharma, AstraZeneca, Allena Pharmaceuticals, DiaMedica Therapeutics Inc., Lexicon Pharmaceuticals, Sanofi, and others.
Chronic Kidney Disease Summary
The Chronic Kidney Disease (CKD) market in the United States was estimated at approximately USD 2,824 million in 2023 and is projected to demonstrate sustained growth throughout the forecast period. The US…

BIS Research Empowers Healthcare Industry with Precision-Driven Primary Market R …
BIS Research is redefining healthcare intelligence through Primary Market Research (PMR), offering validated, real-world data on treatment adoption, patient behavior, and technology uptake. Covering 25+ therapeutic areas, BIS supports pharma, diagnostics, and medtech innovators in aligning with trends like AI adoption, precision medicine, and post-COVID digital healthcare, driving sustainable growth worldwide.
BIS Research, a leading global B2B market intelligence and advisory firm, today announced the expansion of its Primary Market Research…

IBN Technologies' AP AR Automation Drives Financial Growth for U.S. Real Estate …
AP AR automation is reshaping real estate financial management across the U.S. IBN Technologies' end-to-end solutions automate invoice capture, validation, payment processing, and collections while delivering real-time reporting. With benefits such as 30% faster cash flow, 25% more on-time payments, and seamless ERP integration, firms gain stronger financial control and long-term resilience in an evolving market.
Miami, Florida, 03 Sep 2025 The adoption of digital solutions is accelerating in the U.S.…
More Releases for Wet
Wet And Cold Appliance Market Size Analysis by Application, Type, and Region: Fo …
USA, New Jersey- According to Market Research Intellect, the global Wet And Cold Appliance market in the Internet, Communication and Technology category is projected to witness significant growth from 2025 to 2032. Market dynamics, technological advancements, and evolving consumer demand are expected to drive expansion during this period.
The wet and cold appliance market is expanding steadily, driven by changing consumer lifestyles, increasing urbanization, and rising demand for home automation. Appliances…
Semiconductor Electronic Wet Chemicals Market
Semiconductor Electronic Wet Chemicals Market Overview
Electronic wet chemicals are ultra-pure nature due to which they are extensively used in cleaning and etching application during semiconductor production and processing.
This report provides a deep insight into the global Semiconductor Electronic Wet Chemicals market covering all its essential aspects. This ranges from a macro overview of the market to micro details of the market size, competitive landscape, development trend, niche market, key market…
Global Wet Suit Market Analysis (2025-2031)
LPI (LP Information) released the report titled "Global Wet Suit Market Growth (Status and Outlook) 2025-2031." This report provides a comprehensive analysis of the global Wet Suit landscape, with a focus on key trends related to product segmentation, company establishment, revenue and market share, recent developments, and merger and acquisition activities. Additionally, the report delves into the strategies of global leading companies, emphasizing their Wet Suit portfolios and capabilities, market…
Wet and Dry Vacuum Cleaner Market
The "Wet and Dry Vacuum Cleaner Market" is expected to reach USD xx.x billion by 2031, indicating a compound annual growth rate (CAGR) of xx.x percent from 2024 to 2031. The market was valued at USD xx.x billion In 2023.
Growing Demand and Growth Potential in the Global Wet and Dry Vacuum Cleaner Market, 2024-2031
Verified Market Research's most recent report, "Wet and Dry Vacuum Cleaner Market: Global Industry Trends, Share, Size,…
Wet Filtered Downdraught Workbench Market
Wet filtered downdraught workbench is the industry's leading solution for the collection of combustible metal dust which can safely removes combustible materials while complying with NFPA and OSHA combustible dust guidelines.
The global Wet Filtered Downdraught Workbench market was valued at US$ million in 2022 and is anticipated to reach US$ million by 2029, witnessing a CAGR of % during the forecast period 2023-2029. The influence of COVID-19 and the Russia-Ukraine…
Corn Wet-milling Market Corn Wet Milling Market Share, Size, Demand, Key Players …
Market Analysis and Insights of Global Corn Wet-milling Market
The corn wet-milling market is expected to witness market growth at a rate of 5.70% in the forecast period of 2022 to 2029. Data Bridge Market Research report on corn wet-milling market provides analysis and insights regarding the various factors expected to be prevalent throughout the forecast period while providing their impacts on the market's growth. The growth in awareness globally is…