PharmaRadar360

PharmaRadar360

OphthalmologyDrug intelligence

Eylea

Aflibercept

Decoy receptor for VEGF-A and PlGF. Developed by Regeneron. Clinical, regulatory, and source evidence are connected below.

Company
Regeneron
Target / MOA
VEGF-A 路 PlGF
Aliases
Eylea 路 Eylea HD 路 VEGF Trap-Eye
Signals
22
Clinical trials
15
Approvals
2
Evidence sources
22

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy

Phase 2 路 RECRUITING 路 Boehringer Ingelheim

clinical trialClinicalTrials.gov

A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA庐 HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration

Phase 3 路 RECRUITING 路 Amgen

clinical trialClinicalTrials.gov

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration

Phase 2 路 COMPLETED 路 Kyowa Kirin Co., Ltd.

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.

United States (FDA label)

Eylea 路 BLA125387 路 label version 41, effective Jul 7, 2026 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE EYLEA is indicated for the treatment of: 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)

Eylea HD 路 BLA761355 路 label version 12, effective Apr 6, 2026 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE EYLEA HD is indicated for the treatment of: 1.1 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Diabetic Retinopathy (DR) 1.4 Macular Edema Following Retinal Vein Occlusion (RVO)

European Union (EMA)

Eylea 路 EMEA/H/C/002392 路 Authorised, authorised Nov 22, 2012 (Commission decision C(2012) 8698) 路 EPAR

Eylea 114.3 mg/ml solution for injection and Eylea 114.3 mg/ml solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to diabetic macular oedema (DME) visual impairment due to macular oedema secondary to retinal vein occlusion (branch, central and hemiretinal RVO) Eylea 40 mg/mL solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV) Eylea is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease Eylea 40 mg/mL solution for injection in a vial Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV)

EMA's summary; the full indication is in the product information on the EPAR page.

Not covered here: Zaltrap (ziv-aflibercept in the US; EMEA/H/C/002532 in the EU) (Sanofi's aflibercept for colorectal cancer, a different product from Eylea.)

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.

United States

BLA125387 路 REGENERON PHARMACEUTICALS 路 first approved Nov 18, 2011

7 efficacy supplements approved

BLA761355 路 REGENERON PHARMACEUTICALS 路 first approved Aug 18, 2023

2 efficacy supplements approved

European Union

  • Eylea: Authorised since Nov 22, 2012

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.

BLA125387 (Purple Book)

Orphan exclusivity until Feb 8, 2030

BLA761355 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

6 licensed biosimilars
  • Opuviz (Samsung Bioepis Co., Ltd.) 路 BLA761350 路 licensed May 20, 2024 路 interchangeable
  • Yesafili (Biocon Biologics Inc.) 路 BLA761274 路 licensed May 20, 2024 路 interchangeable
  • Ahzantive (Formycon AG) 路 BLA761378 路 licensed Jun 28, 2024
  • Enzeevu (Sandoz Inc.) 路 BLA761382 路 licensed Aug 9, 2024
  • Pavblu (Amgen Inc.) 路 BLA761298 路 licensed Aug 23, 2024
  • Eydenzelt (CELLTRION, Inc.) 路 BLA761377 路 licensed Oct 2, 2025

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.

Boxed warning

The current US labels have no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies 路 15 linked records.

Phase 2RECRUITINGNCT06321302

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy

Boehringer Ingelheim 路 Updated Oct 15, 2026

Phase 3RECRUITINGNCT07614776

A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA庐 HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration

Amgen 路 Updated Oct 14, 2026

Phase 2COMPLETEDNCT06116890

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration

Kyowa Kirin Co., Ltd. 路 Updated Oct 14, 2026

Phase 2ACTIVE NOT RECRUITINGNCT06116916

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema

Kyowa Kirin Co., Ltd. 路 Updated Oct 14, 2026

Phase 3RECRUITINGNCT07867080

A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).

4D Molecular Therapeutics 路 Updated Oct 13, 2026

Phase 3RECRUITINGNCT07705607

A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)

Merck Sharp & Dohme LLC 路 Updated Oct 9, 2026

Related intelligence

Connected drugs

Records connected through the current intelligence graph.

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial 路 Latest Oct 15, 202620FDAofficial 路 Latest Apr 2, 20262
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.