Demonstrated Safety Profile in DME1

The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.1

DME (VISTA and VIVID: results in chart) and DR (PANORAMA: results below chart) Phase 3 Trials: Most Common Adverse Reactions (≥1%)1
Table of the most common adverse reactions in EYLEA DME trials: conjunctival hemorrhage, eye pain, cataract,  vitreous floaters, intraocular pressure increase, ocular hyperemia, corneal epithelium defect, injection-site pain, foreign body sensation in eyes, lacrimation increase, vision blurred, intraocular inflammation, and eyelid edema. Table of the most common adverse reactions in EYLEA DME trials: conjunctival hemorrhage, eye pain, cataract,  vitreous floaters, intraocular pressure increase, ocular hyperemia, corneal epithelium defect, injection-site pain, foreign body sensation in eyes, lacrimation increase, vision blurred, intraocular inflammation, and eyelid edema.
  • Less common adverse reactions reported in <1% of the patients treated with EYLEA were hypersensitivity, retinal detachment, retinal tear, corneal edema, and injection-site hemorrhage
  • Safety data observed in 269 patients with nonproliferative diabetic retinopathy (NPDR) through week 52 in the PANORAMA trial were consistent with those seen in the phase 3 VIVID and VISTA trials
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See More Important Safety Information and Indications
  • CONTRAINDICATIONS: EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
Important Safety Information INDICATIONS

EYLEA® (aflibercept) Injection 2 mg (0.05 mL) is 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), and Diabetic Retinopathy (DR).

Please see the full Prescribing Information for EYLEA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The information provided in this site is intended only for healthcare professionals in the United States. The products discussed herein may have different product labeling in different countries.

Reference
  1. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. August 2019.