EYLEA (aflibercept)
EYLEA is indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD); Macular Edema Following Retinal Vein Occlusion (RVO); Diabetic Macular Edema (DME); Diabetic Retinopathy (DR); Retinopathy of Prematurity (ROP).
How EYLEA Works
Aflibercept functions as a soluble decoy receptor that binds to vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF). By capturing these growth factors, the drug prevents them from binding to and activating VEGFR-1 and VEGFR-2 receptors on the surface of endothelial cells. This inhibition blocks the biological processes that lead to neovascularization and increased vascular permeability.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-11-18
- Patent Cliff
- 2027
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
EYLEA Approval History
What EYLEA Treats
5 indicationsEYLEA is approved for 5 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
- Retinopathy of Prematurity (ROP)
EYLEA Target & Pathway
ProTarget
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
Pathway Context
VEGFR on blood vessels is activated by VEGF to promote angiogenesis
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
EYLEA Biosimilars
6 FDA-approved1 can be substituted at the pharmacy without calling the prescriber. The other 5 require prescriber approval to switch.
What are biosimilars? Lower-cost alternatives to EYLEA with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
EYLEA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to EYLEA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
124 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07440225 MALBEC | 8748-002 | Ph 2, Ph 3 | recruiting | A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) |
| NCT07496567 TORRONTES | 8748-003 MK-8748-003 | Ph 2, Ph 3 | recruiting | A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003) |
| NCT06556368 DAYBREAK | KS301P109 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK |
| NCT07482176 AQUARIUS | ADVM-022-13 | Ph 3 | recruiting | Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS) |
| NCT06850922 THAMES | GR43828 ISRCTN14152148 | Ph 1, Ph 2 | active not recruiting | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema |
| NCT07317934 | INNOSTELLAR-LX102A03 | Ph 3 | recruiting | Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR) |
| NCT06856577 ARTEMIS | ADVM-022-12 | Ph 3 | recruiting | Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration |
| NCT04567550 ALTITUDE® | RGX-314-2202 (M23-414) | Ph 2 | active not recruiting | RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME) |
| NCT03832179 STAMP | STAMP | Ph 4 | completed | Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification |
| NCT04270747 results posted | 20170542 2019-002503-17 | Ph 3 | completed | A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD] |
| NCT02257502 INTUITION | 2013.839 2013-005081-19 | Ph 2 | completed | Study Evaluating the Efficacy of Aflibercept for the Treatment of NVCI in Young Patients |
| NCT04429503 PHOTON results posted | VGFTe-HD-DME-1934 2019-003643-30 | Ph 2, Ph 3 | completed | Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease |
| NCT02556229 ALINEA | 69HCL14_0201 2014-003695-23 | Ph 2 | completed | Study Evaluating the Efficacy of Aflibercept for the Treatment of Inflammatory CNV in Young Patients (ALINEA). |
| NCT06011798 results posted | UBX1325-04 | Ph 2 | completed | Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE) |
| NCT05891548 ODYSSEY | CLS1002-202 | Ph 2 | completed | Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration |
| NCT03823287 results posted | GR40306 2018-002152-32 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA) |
| NCT03622580 results posted | GR40349 2017-005104-10 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE) |
| NCT03622593 RHINE results posted | GR40398 2017-005105-12 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema |
| NCT03823300 results posted | GR40844 2018-004042-42 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE) |
| NCT04418427 INFINITY results posted | ADVM-022-04 | Ph 2 | completed | ADVM-022 Intravitreal Gene Therapy for DME |
| NCT03186326 SAMCO | PRODIGE 54 - FFCD 1603 | Ph 2 | completed | Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer |
| NCT06495918 | OTX-TKI-2023-AMD-303 | Ph 3 | active not recruiting | Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration |
| NCT03397264 results posted | OPT-302-1003 | Ph 1, Ph 2 | completed | A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema |
| NCT06223958 | OTX-TKI-2023-AMD-301 SOL-1 | Ph 3 | active not recruiting | Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration |
| NCT05571267 results posted | OPH2004 | Ph 2 | terminated | Safety Study of Zimura in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD |
| NCT06839339 | AL-001-02 | Ph 2 | not yet recruiting | Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD |
| NCT05704725 results posted | 20210034 2019-002503-17 | Ph 3 | completed | A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD) |
| NCT01652196 results posted | OSU 11182 NCI-2012-01167 | Ph 2 | completed | Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer |
| NCT03481660 KITE results posted | CRTH258B2302 2017-003960-11 | Ph 3 | completed | A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema |
| NCT04820452 | CIBI302A201 | Ph 2 | completed | A Study of IBI302 in Patients With nAMD |
| NCT02387957 results posted | OPH1006 | Ph 2 | terminated | A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer) |
| NCT03396861 ACME | 12338 | Ph 1 | terminated | Treatment of Macular Edema After Cataract Surgery with Subconjunctival Aflibercept |
| NCT04058067 KINGLET results posted | CRTH258B2304 | Ph 3 | completed | To Compare Brolucizumab to Aflibercept in Chinese Patients With Visual Impairment Due to Diabetic Macular Edema |
| NCT04603937 GLIMMER results posted | KS301P105 2020-001063-82 | Ph 3 | terminated | A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) |
| NCT04611152 GLEAM results posted | KS301P104 2020-001062-11 | Ph 3 | terminated | A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) |
| NCT04740931 COMINO results posted | GR41986 2020-000441-13 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion |
| NCT04740905 BALATON results posted | GR41984 2020-000440-63 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion |
| NCT04469595 NEW DAY | 01-20-005 | Ph 4 | active not recruiting | A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME) |
| NCT04049266 DAZZLE results posted | KSI-CL-102 | Ph 2, Ph 3 | terminated | A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. |
| NCT02384759 FOLFA results posted | PRODIGE25 | Ph 2 | completed | Aflibercept +/- LV5FU2 in First Line of Non-resectalbe Metastatic Colorectal Cancers |
| NCT04964089 DAYLIGHT results posted | KS301P107 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) |
| NCT05403749 | CIBI302A202 | Ph 2 | completed | A Study of Longer Interval of IVT IBI302 in Subjects With nAMD |
| NCT04592419 BEACON results posted | KS301P103 2020-001061-37 | Ph 3 | completed | A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) |
| NCT04411693 PRECISION | ALLER1908JE | Ph 4 | completed | Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema |
| NCT05710471 | Switch Study | Ph 4 | completed | Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E |
| NCT02661711 AMOUR results posted | MICM1014 2015-003723-65 | Ph 2 | completed | Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study |
| NCT03984110 COED | TRA-COED-19-001 | Ph 4 | completed | One Year Trial Evaluating Safety of Ozurdex With Eylea |
| NCT03374670 | OPH2006 | Ph 2 | withdrawn | ZIMURA in Combination With Eylea in Patients With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV) |
| NCT05126966 Diagrid | MR42410 2021-003226-71 | Ph 3 | withdrawn | A Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Aflibercept Treat & Extend In Subjects With Neovascular Age-Related Macular Degeneration |
| NCT04739306 results posted | CT-P42 3.1 | Ph 3 | completed | Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema |
Showing 50 of 124 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EYLEA FDA Label Details
Indications & Usage
FDA Label (PDF)EYLEA is indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD); Macular Edema Following Retinal Vein Occlusion (RVO); Diabetic Macular Edema (DME); Diabetic Retinopathy (DR); Retinopathy of Prematurity (ROP).
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment