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Aflibercept - Bayer/Regeneron Pharmaceuticals/Sanofi

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Drug Profile

Aflibercept - Bayer/Regeneron Pharmaceuticals/Sanofi

Alternative Names: aflibercept [genetical recombination]; AVE-0005; BAY-865321; EYLEA; Eylea; EYLEA HD; EYLEA® solution for intravitreal injection; Eylia; REGN3; Vascular endothelial growth factor Trap; Vascular endothelial growth factor Trap-R1R2; VEGF Trap (R1R2); VEGF Trap-Eye; Wetlia; Zaltrap; Ziv-aflibercept

Latest Information Update: 27 Oct 2025

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At a glance

  • Originator Regeneron Pharmaceuticals
  • Developer Bayer; Bayer HealthCare Pharmaceuticals; Bayer Yakuhin; Centre Oscar Lambret; GERCOR; Greater Houston Retina Research; Guys Hospital; Hellenic Cooperative Oncology Group; Moorfields Eye Hospital; National Cancer Institute (USA); Regeneron Pharmaceuticals; Roche; Sanofi; sanofi-aventis; Tufts Medical Center; University of Ulm
  • Class Antineoplastics; Eye disorder therapies; Immunoglobulin Fc fragments; Immunoglobulin fragments; Recombinant fusion proteins
  • Mechanism of Action Placenta growth factor inhibitors; Vascular endothelial growth factor A inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Glaucoma; Retinopathy of prematurity
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Branch retinal vein occlusion; Central retinal vein occlusion; Choroidal neovascularisation; Colorectal cancer; Diabetic macular oedema; Diabetic retinopathy; Glaucoma; Retinal oedema; Retinopathy of prematurity; Wet age-related macular degeneration
  • Phase III Polypoidal choroidal vasculopathy
  • Phase II Central serous chorioretinopathy; Graves ophthalmopathy; Retinal disorders
  • No development reported Malignant ascites; Non-Hodgkin's lymphoma; Ovarian cancer; Solid tumours
  • Discontinued Non-small cell lung cancer; Pancreatic cancer; Prostate cancer

Most Recent Events

  • 19 Sep 2025 Bayer completes the phase III FIREFLEYE next trial for Retinopathy of Prematurity in Argentina, Belgium, Brazil, Bulgaria, Czech Republic , Greece, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, Portugal, Romania, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom (NCT04015180) (EudraCT2018-003180-54)
  • 20 Aug 2025 Regeneron Pharmaceuticals announced that US FDA is expected to make a decision and launch on prefilled syringe for aflibercept 8 mg for macular edema following retinal vein occlusion in fourth quarter of 2025
  • 20 Aug 2025 The US FDA sets PDUFA date of 31/12/2025 for sBLA review for broadening the dosing schedule to include every 4-week dosing across approved indications

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