Demonstrated Safety Profile in Macular Edema following Retinal Vein Occlusion1

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

MEfRVO Phase 3 Trials (COPERNICUS, GALILEO, and VIBRANT): Most Common Adverse Reactions (≥1%)1

BRVO CRVO
Adverse Reactions EYLEA (n=91) Control (n=92) EYLEA (n=91) Control (n=92)
Eye pain 4% 5% 13% 5%
Conjunctival hemorrhage 20% 4% 12% 11%
Intraocular pressure increased 2% 0% 8% 6%
Corneal epithelium defect 2% 0% 5% 4%
Vitreous floaters 1% 0% 5% 1%
Ocular hyperemia 2% 2% 5% 3%
Foreign body sensation in eyes 3% 0% 3% 5%
Vitreous detachment 2% 0% 3% 4%
Lacrimation increased 3% 0% 3% 4%
Injection-site pain 1% 0% 3% 1%
Vision blurred 1% 1% 1% <1%
Intraocular inflammation 0% 0% 1% 1%
Cataract 5% 0% <1% 1%
Eyelid edema 1% 0% <1% 1%
  • Less common adverse reactions reported in <1% of the patients treated with EYLEA in the CRVO studies were corneal edema, retinal tear, hypersensitivity, and endophthalmitis
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See More Important Safety Information and Indications
  • CONTRAINDICATIONS: EYLEA 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.