Product Description
Aflibercept (EYLEA®), initially named VEGF Trap-eye, is the most recent anti-VEGF agent to be granted US Food and Drug Administration approval for the treatment of neovascular AMD. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4689264/)
Mechanisms of Action: VEGF Antagonist
Novel Mechanism: No
Modality: Fusion Protein
Route of Administration: Intravenous
FDA Designation: Priority Review - Macular Edema *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Regeneron
Company Location: Eastern America
Company CEO: Leonard S. Schleifer
Additional Commercial Interests: Bayer
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Croatia, Czech Republic, Estonia, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 35
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Regeneron presented P3 Macular Edema results on 2024-12-17 for Aflibercept
- Clinical Outcomes Reported - Regeneron presented P3 Macular Edema results on 2024-10-18 for Aflibercept
- Clinical Outcomes Reported - Regeneron presented P3 Edema results on 2024-05-09 for Aflibercept
Highest Development Phases
Phase 3: Choroid Diseases|Dyslipidemia|Macular Degeneration|Macular Edema|Neovascular age-related macular degeneration|Other|Retinal Vein Occlusion|Retinopathy of Prematurity|Type 1 Diabetes|Type 2 Diabetes|Wet Macular Degeneration
Phase 2: Colorectal Cancer|Graves Disease|Graves Ophthalmopathy|Retinal Neovascularization|Thyroid Eye Disease|Uveal Melanoma
Phase 1: COVID-19|Malaria
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06817343 |
Everest LTFU | P1 |
Enrolling by invitation |
Wet Macular Degeneration|Neovascular age-related macular degeneration |
2029-02-01 |
50% |
2025-05-16 |
Primary Endpoints|Treatments |
ACTRN12618000968279p |
2006-7041-83/hah | P1 |
Not yet recruiting |
Malaria |
2018-09-25 |
|||
ACTRN12621000468820p |
2006-7041-83/hah | P1 |
Not yet recruiting |
COVID-19 |
2021-11-01 |
|||
NCT06121180 |
MCC-21341 | P2 |
Recruiting |
Uveal Melanoma |
2030-10-31 |
12% |
2024-05-03 |
Primary Endpoints|Start Date|Treatments |
NCT04311606 |
AcTED | P2 |
Completed |
Graves Disease|Graves Ophthalmopathy|Thyroid Eye Disease |
2024-12-17 |
12% |
2026-01-01 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT03530267 |
ELDERLY | P2 |
Completed |
Colorectal Cancer |
2024-02-01 |
76% |
2024-02-24 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2013-001856-36 |
MEDICARE | P2 |
Active, not recruiting |
Retinal Neovascularization |
2015-05-22 |
2022-03-13 |
Treatments |
|
NCT05251636 |
KILAUEA | P3 |
Not yet recruiting |
Choroid Diseases|Macular Degeneration |
2026-09-01 |
2023-08-31 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
|
NCT06422507 |
PHOTONiC | P3 |
Active, not recruiting |
Macular Edema |
2025-12-29 |
25% |
2026-01-03 |
Primary Endpoints |
NCT04015180 |
FIREFLEYE next | P3 |
Completed |
Retinopathy of Prematurity |
2025-09-19 |
59% |
2025-10-11 |
Primary Endpoints |
NCT06491914 |
ELARA | P3 |
Active, not recruiting |
Neovascular age-related macular degeneration|Macular Edema |
2025-08-26 |
27% |
2025-10-16 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT05850520 |
QUASAR | P3 |
Completed |
Retinal Vein Occlusion|Macular Edema |
2024-11-07 |
43% |
2025-06-05 |
|
jRCT2080225235 |
jRCT2080225235 | P3 |
Completed |
Type 2 Diabetes|Type 1 Diabetes|Macular Edema |
2024-09-30 |
|||
jRCT2031220316 |
jRCT2031220316 | P3 |
Recruiting |
Wet Macular Degeneration|Dyslipidemia |
2024-07-31 |
|||
NCT05704725 |
NCT05704725 | P3 |
Completed |
Other |
2023-02-17 |
43% |
2023-03-31 |
Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2019-003851-12 |
PULSAR | P3 |
Completed |
Neovascular age-related macular degeneration |
2024-08-07 |
36% |
2025-07-09 |
Treatments |
NCT05989126 |
VGFTe-HD-OD-22105 | P3 |
Completed |
Neovascular age-related macular degeneration|Wet Macular Degeneration|Macular Edema |
2024-05-31 |
23% |
2024-06-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05387837 |
Tejas | P2 |
Active, not recruiting |
Macular Edema|Neovascular age-related macular degeneration |
2025-05-09 |
50% |
2025-05-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2017-002219-33 |
seconD-line folfiri/aflIbercept in proSpecTIvely stratified metastatic coloreCTal cancer patIents | P2 |
Completed |
Colorectal Cancer |
2025-01-24 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2024-513231-24-00 |
VGFTe-ROP-2036 | P3 |
Active, not recruiting |
Retinopathy of Prematurity |
2026-11-04 |
2025-05-02 |
Treatments |
|
2023-504207-89-00 |
20275 | P3 |
Active, not recruiting |
Retinopathy of Prematurity |
2025-07-03 |
59% |
2025-05-02 |
Treatments |
jRCT2031230147 |
jRCT2031230147 | P3 |
Recruiting |
Macular Edema|Retinal Vein Occlusion |
2025-05-16 |
|||
2022-502174-16-00 |
22153 | P3 |
Active, not recruiting |
Retinal Vein Occlusion|Macular Edema |
2025-05-16 |
43% |
2025-05-02 |
Treatments |
JapicCTI-205174 |
JapicCTI-205174 | P3 |
Active |
Retinopathy of Prematurity |
2025-05-15 |
|||
2024-512880-30-00 |
OPT-302-1005 | P3 |
Completed |
Neovascular age-related macular degeneration|Wet Macular Degeneration |
2025-03-31 |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/08/2026 |
News Article |
Ollin Biosciences Announces Positive Topline Data with Superior Outcomes from a Randomized Head-to-Head Study of OLN324 Compared to Faricimab (Vabysmo®) in Diabetic Macular Edema and Wet Age-Related Macular Degeneration |
|
01/07/2026 |
News Article |
EyePoint Reports Corporate Update and Anticipated Pivotal Milestones for 2026 |
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01/07/2026 |
News Article |
4DMT Provides Company Update and Anticipated Development Milestones for 2026 |
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12/31/2025 |
News Article |
Alvotech Secures Term Loan Facility of USD 100 Million |