TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

EYLEA

AFLIBERCEPT Vascular Endothelial Growth Factor Inhibitors
Ophthalmology Approved 2011-11-18

Eylea (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of several serious retinal conditions. It is used in adult patients to treat neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. The medication is also approved for the treatment of retinopathy of prematurity in pediatric patients.

Source: FDA Label • Regeneron • Vascular Endothelial Growth Factor Inhibitor

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.

Source: FDA Label
8
Indications
--
Phase 3 Trials
3
Priority Reviews
14
Years on Market

Details

Status
Prescription
First Approved
2011-11-18
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: AFLIBERCEPT

EYLEA Approval History

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What EYLEA Treats

5 indications

EYLEA 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)
Source: FDA Label

EYLEA Target & Pathway

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Target

VEGFR (Vascular Endothelial Growth Factor Receptor) Growth Factor Receptor

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

VEGF (Vascular Endothelial Growth Factor) ligand

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-approved

1 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 Competitors

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2 other drugs also target VEGFR. Compare mechanisms, indications, and trial activity.

Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications → Date = Patent/exclusivity expiry

Competitors share the same molecular target (VEGFR). Earlier expiry dates signal biosimilar/generic opportunities.

Drugs Similar to EYLEA

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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

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Indications & Usage

FDA Label (PDF)

EYLEA is indicated for the treatment of: EYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: 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) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Diabetic Macular Edema (DME) 1.4 Diabetic Retinopathy (DR) 1.5 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.