Demonstrated Safety Profile in Wet AMD1

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

Wet AMD Phase 3 Trials (VIEW 1 and VIEW 2): Most Common Adverse Reactions (≥1%)1
Baseline to Week 52 Baseline to Week 96
Adverse Reactions EYLEA
(n=1824)
Active Control
(ranibizumab) (n=595)
EYLEA
(n=1824)
Control
(ranibizumab) (n=595)
Conjunctival hemorrhage 25% 28% 27% 30%
Eye pain 9% 9% 10% 10%
Cataract 7% 7% 13% 10%
Vitreous detachment 6% 6% 8% 8%
Vitreous floaters 6% 7% 8% 10%
Intraocular pressure increased 5% 7% 7% 11%
Ocular hyperemia 4% 8% 5% 10%
Corneal epithelium defect 4% 5% 5% 6%
Detachment of the retinal
pigment epithelium
3% 3% 5% 5%
Injection-site pain 3% 3% 3% 4%
Foreign body sensation in eyes 3% 4% 4% 4%
Lacrimation increased 3% 1% 4% 2%
Vision blurred 2% 2% 4% 3%
Intraocular inflammation 2% 3% 3% 4%
Retinal pigment epithelium tear 2% 1% 2% 2%
Injection-site hemorrhage 1% 2% 2% 2%
Eyelid edema 1% 2% 2% 3%
Corneal edema 1% 1% 1% 1%
Retinal detachment <1% <1% 1% 1%
  • Less common serious adverse reactions reported in <1% of the patients treated with EYLEA were hypersensitivity, retinal tear, 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.