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 Founding Year: 1988
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: 37
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 |
Neovascular age-related macular degeneration|Wet Macular Degeneration |
2029-02-01 |
50% |
2025-05-16 |
Primary Endpoints|Treatments |
ACTRN12621000468820p |
2006-7041-83/hah | P1 |
Not yet recruiting |
COVID-19 |
2021-11-01 |
|||
ACTRN12618000968279p |
2006-7041-83/hah | P1 |
Not yet recruiting |
Malaria |
2018-09-25 |
|||
NCT06121180 |
MCC-21341 | P2 |
Recruiting |
Uveal Melanoma |
2030-10-31 |
12% |
2024-05-03 |
Primary Endpoints|Start Date|Treatments |
NCT04311606 |
AcTED | P2 |
Completed |
Thyroid Eye Disease|Graves Disease|Graves Ophthalmopathy |
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 |
|
NCT07389980 |
PALLAS | P3 |
Recruiting |
Other |
2028-11-01 |
10% |
2026-02-06 |
|
NCT05251636 |
KILAUEA | P3 |
Not yet recruiting |
Macular Degeneration|Choroid Diseases |
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 |
39% |
2026-01-03 |
Primary Endpoints |
NCT04015180 |
FIREFLEYE next | P3 |
Completed |
Retinopathy of Prematurity |
2025-09-19 |
59% |
2025-10-11 |
Primary Endpoints |
NCT05850520 |
QUASAR | P3 |
Completed |
Macular Edema|Retinal Vein Occlusion |
2024-11-07 |
43% |
2025-06-05 |
|
jRCT2080225235 |
jRCT2080225235 | P3 |
Completed |
Macular Edema|Type 1 Diabetes|Type 2 Diabetes |
2024-09-30 |
|||
jRCT2031220316 |
jRCT2031220316 | P3 |
Recruiting |
Wet Macular Degeneration|Dyslipidemia |
2024-07-31 |
|||
2024-512880-30-00 |
OPT-302-1005 | P3 |
Completed |
Wet Macular Degeneration|Neovascular age-related macular degeneration |
2025-03-31 |
2025-05-02 |
Treatments |
|
2019-003851-12 |
PULSAR | P3 |
Completed |
Neovascular age-related macular degeneration |
2024-08-07 |
36% |
2025-07-09 |
Treatments |
2025-522231-34-00 |
AVT29-GL-C01 | P3 |
Not yet recruiting |
Macular Edema |
2027-12-31 |
|||
2024-513231-24-00 |
VGFTe-ROP-2036 | P3 |
Active, not recruiting |
Retinopathy of Prematurity |
2026-11-04 |
2025-05-02 |
Treatments |
|
NCT05387837 |
Tejas | P2 |
Active, not recruiting |
Neovascular age-related macular degeneration|Macular Edema |
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 |
|
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 |
2023-504207-89-00 |
20275 | P3 |
Active, not recruiting |
Retinopathy of Prematurity |
2025-07-03 |
59% |
2025-05-02 |
Treatments |
2022-502174-16-00 |
22153 | P3 |
Active, not recruiting |
Macular Edema|Retinal Vein Occlusion |
2025-05-16 |
43% |
2025-05-02 |
Treatments |
jRCT2031230147 |
jRCT2031230147 | P3 |
Recruiting |
Retinal Vein Occlusion|Macular Edema |
2025-05-16 |
|||
JapicCTI-205174 |
JapicCTI-205174 | P3 |
Active |
Retinopathy of Prematurity |
2025-05-15 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
03/09/2026 |
News Article |
Olatorepatide Obesity Treatment Licensed by Regeneron Demonstrates Positive Phase 3 Results in Chinese Patients |
|
02/10/2026 |
News Article |
Regeneron Highlights Expanding Immunology Portfolio and Pipeline at AAAAI, Showcasing Novel Approaches to Treating Allergy |
|
02/09/2026 |
News Article |
4DMT Completes Enrollment for 4FRONT-1 Phase 3 Clinical Trial of 4D-150 in Wet AMD |
|
02/02/2026 |
News Article |
Alvotech enters supply and commercialization agreements for Canada and Australia & New Zealand covering multiple biosimilar candidates |