Aflibercept

Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells. VEGF acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells.

• EYLEA HD is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Diabetic Retinopathy (DR) ( 1.3 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.4 ) 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)ICD-10: R60.9

• Ocular or periocular infection ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections EYLEA HD is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation EYLEA HD is contraindicated in patients with active intraocular inflammation.contraindicated

Neovascular (Wet) Age-Related Macular Degeneration (nAMD) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week. ( 2.2 ) Some patients did not maintain a response with 8 mg once every 8 to 16 weeks, +/- 1 week, after successful response to the three initial monthly doses. These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days). ( 2.2 ) Extended dosing intervals (8 mg once every 20 weeks, +/- 1 week) may be considered after one year of successful response based on visual and anatomic outcomes. ( 2.2 ). Diabetic Macular Edema (DME) The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week. ( 2.3 ) Some patients did not maintain a response with 8 mg once every 8 to 16 weeks, +/- 1 week, after successful response to the three initial monthly doses. These patients may benefit from resuming every 4-week dosing (approximately every 28 days +/- 7 days). ( 2.3 ) Extended dosing intervals (8 mg once every 20 weeks, +/- 1 week) may be considered after one year of successful response based on visual and anatomic outcomes.

Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. ( 5.1 ) Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. ( 5.2 ) There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ( 5.3 ) 5.1 Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion Intravitreal injections including those with aflibercept have been associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] and, more rarely, retinal vasculitis with or without occlusion [see Adverse Reactions (6.2) ] . Proper aseptic injection technique must always be used when administering EYLEA HD. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately [see Dosage and Administration (2.7) and Patient Counseling Information (17) ]. 5.2 Increase in Intraocular Pressure Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA HD [see Adverse Reactions (6.1) ].

The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3) ] Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion [see Warnings and Precautions (5.1) ] Increase in intraocular pressure [see Warnings and Precautions (5.2) ] Thromboembolic events [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, corneal epithelium defect, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, retinal hemorrhage, vision blurred, vitreous detachment, and vitreous floaters. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-855-395-3248 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice. A total of 1755 patients were treated with EYLEA HD and 804 patients were treated with EYLEA 2 mg in three clinical studies. The most common adverse reactions reported in ≥3% of patients treated with EYLEA HD were cataract, conjunctival hemorrhage, corneal epithelium defect, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, retinal hemorrhage, vision blurred, vitreous detachment and vitreous floaters.

8.1 Pregnancy Risk Summary Adequate and well-controlled studies with EYLEA HD have not been conducted in pregnant women. Aflibercept produced adverse embryofetal effects in rabbits, including external, visceral, and skeletal malformations. A fetal No Observed Adverse Effect Level (NOAEL) was not identified. At the lowest dose shown to produce adverse embryofetal effects, systemic exposure (based on AUC for free aflibercept) was approximately 0.9 -fold of the population pharmacokinetic estimated exposure in humans after an intravitreal dose of 8 mg (see Data ) . Animal reproduction studies are not always predictive of human response, and it is not known whether EYLEA HD can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for aflibercept [see Clinical Pharmacology (12.1) ] , treatment with EYLEA HD may pose a risk to human embryofetal development. EYLEA HD should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Metabolism

EYLEA HD is administered intravitreally to exert local effects in the eye. In patients with wet AMD, or DME, following intravitreal administration of EYLEA HD, a fraction of the administered dose is expected to bind with endogenous VEGF in the eye to form an inactive aflibercept: VEGF complex.

Overdosing with increased injection volume may increase intraocular pressure. Therefore, in case of overdosage, intraocular pressure should be monitored and if deemed necessary by the treating physician, adequate treatment should be initiated.

• Nov 18, 2011BLABLA125387Regeneron Pharmaceuticals
• Aug 3, 2012BLABLA125418Sanofi Aventis Us
• Aug 18, 2023BLABLA761355Regeneron Pharmaceuticals
• Jun 28, 2024BLABLA761378Formycon Ag
• Aug 23, 2024BLABLA761298Amgen Inc

1. 1Death7,92825%
2. 2Visual Impairment2,0946.6%
3. 3Off Label Use1,6205.1%
4. 4Blindness1,4714.6%
5. 5Endophthalmitis1,4054.4%
6. 6Visual Acuity Reduced1,2694.0%
7. 7Eye Pain1,2163.8%
8. 8Drug Ineffective1,1993.8%
9. 9Vision Blurred1,1953.7%
10. 10Product Dose Omission Issue1,1253.5%
11. 11Blindness Unilateral1,0813.4%
12. 12Blindness Transient1,0373.2%
13. 13Eye Inflammation9983.1%
14. 14Eye Haemorrhage8172.6%
15. 15Vitreous Floaters7922.5%

The 10 most recently updated of 595 ClinicalTrials.gov registrations naming Aflibercept as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration
  Recruiting · Phase 3 · Interventional · 304 enrolled · Amgen
  NCT07614776updated 2026-06-12
• A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
  Active not recruiting · Phase 2 · Interventional · 190 enrolled · Boehringer Ingelheim
  NCT06321302updated 2026-06-12
• Real-world Study of Aflibercept 8 mg in nAMD
  Recruiting · Observational · 300 enrolled · Peking University People's Hospital
  NCT07640997updated 2026-06-11
• Dynamic Changes in Circulating Tumour Cells Protein Expression
  Recruiting · Phase 2 · Interventional · 150 enrolled · Matteo's Friends
  NCT06314997updated 2026-06-10
• Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT
  Recruiting · Interventional · 308 enrolled · Zhongshan Ophthalmic Center, Sun Yat-sen University
  NCT06610747updated 2026-06-08
• Study of the SCD411 Prefilled Syringe for Treating Adults With Wet Age-Related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema, or Diabetic Retinopathy
  Completed · Phase 2 · Interventional · 33 enrolled · Sam Chun Dang Pharm. Co. Ltd.
  NCT07501052updated 2026-06-08
• A Study to Collect Data on the Use of Eylea in Babies Born Too Early Who Have a Condition of the Eye Where Blood Vessels Grow Abnormally in the Retina (Retinopathy of Prematurity)
  Active not recruiting · Observational · 75 enrolled · Bayer
  NCT05705258updated 2026-06-08
• Ixoberogene Soroparvovec (Ixo-vec) Contralateral Dosing Study in Participants With Neovascular Age-related Macular Degeneration
  Recruiting · Phase 2 · Interventional · 15 enrolled · Adverum Biotechnologies, Inc.
  NCT07630649updated 2026-06-05
• COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
  Recruiting · Phase 3 · Interventional · 240 enrolled · EyePoint Pharmaceuticals, Inc.
  NCT07449936updated 2026-06-03
• CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
  Recruiting · Phase 3 · Interventional · 240 enrolled · EyePoint Pharmaceuticals, Inc.
  NCT07449923updated 2026-06-03

Frequently asked questions

How does Aflibercept work?

Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells. VEGF acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells.

What is Aflibercept used for?

According to FDA labeling, Aflibercept carries indications including: EYLEA HD is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Diabetic Retinopathy (DR) ( 1.3 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.4 ) 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). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Aflibercept?

Aflibercept is classified as Antineovascularisation agents, Other antineoplastic agents, Vascular Endothelial Growth Factor Inhibitor, Vascular Endothelial Growth Factor Inhibitors, Decreased Vascular Permeability.

What are the brand names for Aflibercept?

Aflibercept is marketed under brand names including Ahzantive, Eydenzelt, Eylea, Opuviz, Pavblu, Zaltrap.

What are the contraindications for Aflibercept?

Aflibercept labeling lists contraindications including: Ocular or periocular infection ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections EYLEA HD is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation EYLEA HD is contraindicated in patients with active intraocular inflammation.. Always consult the full prescribing information and a clinician.