CLINICAL TRIALS PROFILE FOR AFLIBERCEPT

Biosimilar Clinical Trials for aflibercept

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04450329 ↗	A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)	Active, not recruiting	Samsung Bioepis Co., Ltd.	Phase 3	2020-06-23	This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, PK, and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.
NCT04480463 ↗	A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD)	Recruiting	Sam Chun Dang Pharm. Co. Ltd.	Phase 3	2020-08-13	Age-related macular degeneration (AMD) is a leading cause of vision loss in adults. Abnormal blood vessels grow under the macula at the back of the eye, and also leak blood and fluid, which damages and scars the macula, affecting vision. The current standard of care for patients with neovascular (exudative / wet) AMD is anti-vascular endothelial growth factor (anti-VEGF) therapy, which prevents or slows down the growth of the abnormal blood vessels. SCD411 is being developed as a biosimilar to the reference product Eylea® (aflibercept), an anti-VEGF drug. The study aims to prove equivalence of SCD411 to Eylea in adults with wet AMD, and will look at safety, tolerance, effectiveness, immune response and the movement of the drug through the body.
NCT04522167 ↗	Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration	Recruiting	Bioeq GmbH	Phase 3	2020-07-21	This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.

All Clinical Trials for aflibercept

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00284141 ↗	Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma	Completed	Regeneron Pharmaceuticals	Phase 2	2006-01-01	This study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA). Primary objective: - To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in participants with platinum- and erlotinib-resistant, locally advanced or metastatic NSCLA. Secondary objective: - To assess duration of response (DR), progression-free survival (PFS), and overall survival (OS) in this participant population - To evaluate the safety profile of IV AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®). This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. In addition, both Response Evaluation Criteria In Solid Tumors (RECIST) and Modified Response Evaluation Criteria In Solid Tumors (mRECIST) were used to assess tumors. Where as RECIST criteria only consider the longest diameter of the tumors for calculations pertaining to changes in tumor size, mRECIST assessments also account for the differences in the cavities of lesions observed in non-small-cell lung cancer (NSCLC). Responses based on RECIST and mRECIST are reported.
NCT00284141 ↗	Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma	Completed	Sanofi	Phase 2	2006-01-01	This study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA). Primary objective: - To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in participants with platinum- and erlotinib-resistant, locally advanced or metastatic NSCLA. Secondary objective: - To assess duration of response (DR), progression-free survival (PFS), and overall survival (OS) in this participant population - To evaluate the safety profile of IV AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®). This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. In addition, both Response Evaluation Criteria In Solid Tumors (RECIST) and Modified Response Evaluation Criteria In Solid Tumors (mRECIST) were used to assess tumors. Where as RECIST criteria only consider the longest diameter of the tumors for calculations pertaining to changes in tumor size, mRECIST assessments also account for the differences in the cavities of lesions observed in non-small-cell lung cancer (NSCLC). Responses based on RECIST and mRECIST are reported.
NCT00320775 ↗	Safety and Tolerability Study of Intravitreal VEGF-Trap Administration in Patients With Neovascular AMD	Completed	Bayer	Phase 1	2005-06-01	The purpose of this trial is to assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

Clinical Trial Conditions for aflibercept

Condition Name

Condition Name for aflibercept
Intervention	Trials
Diabetic Macular Edema	68
Neovascular Age-Related Macular Degeneration	41
Macular Edema	18

Condition MeSH

Condition MeSH for aflibercept
Intervention	Trials
Macular Degeneration	126
Macular Edema	106
Edema	76

Clinical Trial Locations for aflibercept

Trials by Country

Trials by Country for aflibercept
Location	Trials
Japan	192
Italy	119
China	106
Germany	97
United Kingdom	93

Trials by US State

Trials by US State for aflibercept
Location	Trials
California	90
Texas	88
Florida	65
New York	62
Maryland	58

Clinical Trial Progress for aflibercept

Clinical Trial Phase

Clinical Trial Phase for aflibercept
Clinical Trial Phase	Trials
PHASE4	13
PHASE3	9
PHASE2	6

Clinical Trial Status

Clinical Trial Status for aflibercept
Clinical Trial Phase	Trials
Completed	182
RECRUITING	72
Unknown status	34

Clinical Trial Sponsors for aflibercept

Sponsor Name

Sponsor Name for aflibercept
Sponsor	Trials
Regeneron Pharmaceuticals	102
Bayer	50
Sanofi	39

Sponsor Type

Sponsor Type for aflibercept
Sponsor	Trials
Industry	310
Other	297
NIH	17

Clinical Trials Update, Market Analysis, and Projection for Aflibercept

Last updated: October 31, 2025

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Introduction

Aflibercept, marketed under the brand name Eylea among others, is a recombinant fusion protein that acts as a vascular endothelial growth factor (VEGF) trap, inhibiting angiogenesis. Approved initially for indications like neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion, aflibercept’s therapeutic profile positions it as a key player in ophthalmology and oncology. This report synthesizes recent clinical trial updates, examines market dynamics, and projects future trends shaping aflibercept’s commercial landscape.

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Clinical Trials Update: Recent Developments and Ongoing Studies

Regulatory Approvals and Clinical Efficacy

Aflibercept received its first approval in 2011 by the U.S. Food and Drug Administration (FDA) for the treatment of nAMD. Since then, several pivotal clinical trials have confirmed its efficacy:

• VIEW 1 and VIEW 2 Trials: These randomized, controlled studies established the non-inferiority of aflibercept (2 mg every 8 weeks after three initial doses) compared to ranibizumab (0.5 mg monthly), significantly reducing treatment frequency without compromising efficacy. The trials demonstrated substantial improvements in visual acuity and retinal fluid resolution.

• VISTA and VIVID Trials: Focused on diabetic macular edema, these phase III trials indicated that aflibercept 2 mg administered every 8 weeks post-loading phase surpassed laser therapy, showing marked BCVA (best-corrected visual acuity) gains and retinal fluid reduction.

• KINGFISHER and PHOENIX Trials: Investigating aflibercept in wet age-related macular degeneration and diabetic retinopathy, these studies report promising outcomes, though some are ongoing or preliminary.

Emerging Indications and Ongoing Clinical Trials

• Retinal Vein Occlusion (RVO): Aflibercept’s efficacy in branch and central RVO remains under investigation, with Phase III trials (e.g., COPERNICUS and GALILEO) demonstrating significant visual improvement and fluid reduction.

• Neovascular Glaucoma and Choroidal Neovascularization in Myopic Patients: Early-phase trials are exploring aflibercept’s utility in these indications, reflecting an expansion into broader ophthalmic uses.

• Oncology Applications: Investigations are underway into aflibercept’s role in various cancers, including colorectal, ovarian, and lung cancers, often in combination with chemotherapy or immunotherapy. Notably, phase II trials assessing its anti-angiogenic effects continue to generate preliminary efficacy data.

Safety Profile and Adverse Events

Clinical trials generally affirm aflibercept’s safety, with ocular adverse events like transient intraocular inflammation, increased intraocular pressure, and conjunctival hemorrhages being most common. Systemic adverse events are rare but include hypertension and arterial thromboembolic events. Ongoing surveillance and post-marketing studies are refining understanding of its safety profile.

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Market Analysis

Current Market Landscape

The global ophthalmology drug market is projected to reach USD 15.63 billion by 2027, driven predominantly by age-related macular degeneration, diabetic retinopathy, and other retinal disorders [1]. Aflibercept’s share within this segment is substantial owing to its efficacy and dosing convenience.

• Market Share: In 2022, aflibercept held approximately 30-35% of the anti-VEGF market in ophthalmology, trailing slightly behind ranibizumab but ahead of bevacizumab, owing to its extended dosing schedule and approved indications [2].

• Regional Penetration: North America and Europe dominate aflibercept adoption, supported by strong healthcare infrastructure, higher disease prevalence, and regulatory approvals. Emerging markets in Asia-Pacific are witnessing rapid growth, facilitated by increasing awareness and improved healthcare access.

Competitive Landscape

Aflibercept competes primarily with ranibizumab (Lucentis) and bevacizumab (Avastin), both of which target VEGF pathways, but differ in licensing status, dosing, and cost.

• Advantages: Longer dosing intervals (8 weeks), proven efficacy, and broader indications contribute to market preference.

• Challenges: Cost considerations, particularly in low- and middle-income countries, limit accessibility. Generic versions of bevacizumab have further constrained aflibercept’s market penetration where cost is a primary factor.

Market Drivers and Barriers

• Drivers: Increasing prevalence of retinal diseases due to aging populations, rising diabetic populations, and innovations in drug delivery methods.

• Barriers: High treatment costs, need for repeated intravitreal injections, and systemic safety concerns could hinder growth.

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Market Projection and Future Trends

Forecast Overview (2023-2028)

The anti-VEGF segment, including aflibercept, is projected to grow at a compound annual growth rate (CAGR) of approximately 7-9% over the next five years. The proliferation of new indications, formulation innovations, and expanded geographical access fuel this projected expansion.

Key Factors Influencing Growth

• Expanding Indications: Ongoing trials in wet AMD, diabetic retinopathy, and oncology suggest potential for future approvals. For instance, data indicating aflibercept’s utility in neovascular glaucoma and high myopia could unlock new market segments.

• Technological Innovations: Development of sustained-release formulations and drug delivery systems (e.g., port delivery systems) could reduce injection frequency, improve patient compliance, and increase market share.

• Regulatory Developments: Approvals in emerging markets and potential label expansions substantiate growth forecasts.

• Pricing and Reimbursement Policies: Favorable reimbursement schemes and cost-reduction strategies (biosimilars or generics) could catalyze adoption, especially in resource-limited settings.

Challenges to Future Growth

• Market Saturation: In mature markets, largely driven by retinal disease prevalence, growth may plateau unless new indications or improved formulations emerge.

• Competitive Dynamics: The entry of biosimilars or novel therapeutics offers potential price competition, possibly eroding margins.

• Safety Concerns: Rare but severe systemic adverse effects may impact perception and prescribing behaviors.

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Key Takeaways

• Clinical landscape: Aflibercept continues to demonstrate robust efficacy across approved ophthalmic indications, with ongoing trials expanding its potential uses into oncology and other eye diseases.

• Market positioning: It holds a significant share in the anti-VEGF market, driven by dosing convenience and validated efficacy, yet faces stiff competition from ranibizumab and off-label use of bevacizumab.

• Growth outlook: The global aflibercept market is poised for steady growth, bolstered by expanding indications, technological advances, and emerging markets.

• Strategic considerations: Stakeholders should monitor ongoing clinical developments, competitive movements, and regulatory changes to optimize market positioning.

• Addressing barriers: Cost management and improved delivery methods will be crucial to expanding access, especially in emerging markets.

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FAQs

1. What are the key clinical advantages of aflibercept over other anti-VEGF agents?
Aflibercept offers longer dosing intervals (typically every 8 weeks after initial loading), proven non-inferiority to ranibizumab, and broader indications, making it a preferred choice in certain patient populations.

2. Which emerging indications could significantly impact aflibercept’s market?
Ongoing trials in neovascular glaucoma, high myopia, and various cancers suggest these could be significant future markets once approval is secured.

3. How do safety concerns influence aflibercept’s clinical use?
While generally safe, rare systemic thromboembolic events necessitate careful patient selection and monitoring, especially in high-risk individuals.

4. What are the main competitive challenges facing aflibercept?
Cost considerations, especially in resource-limited settings, and competition from biosimilars and off-label bevacizumab use pose significant market challenges.

5. How might technology innovations shape aflibercept’s future market?
Advances like sustained-release formulations and port delivery systems could reduce injection frequency, improve patient compliance, and expand its applicability.

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References

[1] Market Insights Reports, Ophthalmology Drug Market Forecast, 2022.
[2] GlobalData Healthcare, Anti-VEGF Market Share Analysis, 2022.
[3] RISE Clinical Trial Registry, Aflibercept Trials Overview, 2023.
[4] ClinicalTrials.gov, Ongoing Studies on Aflibercept, 2023.
[5] FDA Approvals Database, Aflibercept Indications, 2011–2022.