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
Baseline to 52 Weeks Baseline to 100 Weeks
Adverse Reactions EYLEA (n=578) Control (n=287) EYLEA (n=578) Control (n=287)
Conjunctival hemorrhage 28% 17% 31% 21%
Eye pain 9% 6% 11% 9%
Cataract 8% 9% 19% 17%
Vitreous floaters 6% 3% 8% 6%
Corneal epithelium defect 5% 3% 7% 5%
Intraocular pressure increased 5% 3% 9% 5%
Ocular hyperemia 5% 6% 5% 6%
Vitreous detachment 3% 3% 8% 6%
Foreign body sensation in eyes 3% 3% 3% 3%
Lacrimation increased 3% 2% 4% 2%
Vision blurred 2% 2% 3% 4%
Intraocular inflammation 2% <1% 3% 1%
Injection-site pain 2% <1% 2% <1%
Eyelid edema <1% 1% 2% 1%
  • 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 clinical trials
  • No new safety signals were identified through year 2 in the PANORAMA trial compared with the known safety profile of EYLEA in the DR population2
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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.

References
  1. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. August 2019.
  2. Wykoff CC. Intravitreal Aflibercept for Moderately Severe to Severe Non-Proliferative Diabetic Retinopathy (NPDR): 2-Year Outcomes of the Phase 3 PANORAMA Study. Data presented at: Angiogenesis, Exudation and Degeneration Annual Meeting; February 8, 2020; Miami, FL.