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: TARRYTOWN NY 10591
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, 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|Obstetric Labor, Premature|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 |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| MCC-21341 | P2 |
Recruiting |
Uveal Melanoma |
2030-10-31 |
12% |
2024-05-03 |
Primary Endpoints|Start Date|Treatments |
| 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 |
|
| FIREFLEYE next | P3 |
Active, not recruiting |
Retinopathy of Prematurity|Obstetric Labor, Premature |
2025-10-01 |
58% |
2025-03-05 |
|
| AcTED | P2 |
Recruiting |
Graves Disease|Thyroid Eye Disease|Graves Ophthalmopathy |
2025-09-30 |
12% |
2023-03-21 |
|
| ELARA | P3 |
Active, not recruiting |
Neovascular age-related macular degeneration|Wet Macular Degeneration|Macular Edema |
2025-08-21 |
66% |
2025-04-30 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| jRCT2031230147 | P3 |
Recruiting |
Macular Edema|Retinal Vein Occlusion |
2025-05-16 |
|||
| 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 |
| MEDICARE | P2 |
Active, not recruiting |
Retinal Neovascularization |
2015-05-22 |
2022-03-13 |
Treatments |
|
| 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 |
|
| jRCT2080225235 | P3 |
Completed |
Type 1 Diabetes|Macular Edema|Type 2 Diabetes |
2024-09-30 |
|||
| jRCT2031220316 | P3 |
Recruiting |
Dyslipidemia|Wet Macular Degeneration |
2024-07-31 |
|||
| NCT05704725 | P3 |
Completed |
Other |
2023-02-17 |
53% |
2023-03-31 |
Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| 2006-7041-83/hah | P1 |
Not yet recruiting |
COVID-19 |
2021-11-01 |
|||
| 2006-7041-83/hah | P1 |
Not yet recruiting |
Malaria |
2018-09-25 |
|||
| Everest LTFU | P1 |
Enrolling by invitation |
Neovascular age-related macular degeneration|Wet Macular Degeneration |
2029-02-01 |
23% |
2025-05-16 |
Primary Endpoints|Treatments |
| VGFTe-ROP-2036 | P3 |
Active, not recruiting |
Retinopathy of Prematurity |
2026-11-04 |
2025-05-02 |
Treatments |
|
| PHOTONiC | P3 |
Active, not recruiting |
Macular Edema |
2025-12-30 |
79% |
2025-01-30 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| 20275 | P3 |
Active, not recruiting |
Retinopathy of Prematurity |
2025-07-03 |
58% |
2025-05-02 |
Treatments |
| 22153 | P3 |
Active, not recruiting |
Macular Edema|Retinal Vein Occlusion |
2025-05-16 |
81% |
2025-05-02 |
Treatments |
| JapicCTI-205174 | P3 |
Active |
Retinopathy of Prematurity |
2025-05-15 |
|||
| OPT-302-1005 | P3 |
Completed |
Wet Macular Degeneration|Neovascular age-related macular degeneration |
2025-03-31 |
2025-05-02 |
Treatments |
|
| QUASAR | P3 |
Completed |
Retinal Vein Occlusion|Macular Edema |
2024-11-07 |
81% |
2025-06-05 |
|
| PULSAR | P3 |
Completed |
Neovascular age-related macular degeneration |
2024-08-07 |
36% |
2025-06-17 |
Treatments |
| 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 |
| jRCT2071210144 | P3 |
Recruiting |
Neovascular age-related macular degeneration |
2024-04-03 |