About EYLEA Results of phase 3 Eylea
clinical trials1
SEE THE DATA

A legacy of clinical experience

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9 years of extensive real-world experience1

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≈13 million doses administered to >1 million eyes since launch (and counting)9

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8 phase 3 clinical trials, including >3000 EYLEA-treated patients across all approved indications: Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (MEfRVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR)1,9

EYLEA® (aflibercept) Injection pre-filled syringe and packaging. EYLEA® (aflibercept) Injection pre-filled syringe and packaging.
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    AMD, Age-Related Macular Degeneration; anti-
    VEGF, anti–vascular endothelial growth factor;
    DME, Diabetic Macular Edema; DR, Diabetic
    Retinopathy; MEfRVO, Macular Edema following
    Retinal Vein Occlusion (includes Branch Retinal
    Vein Occlusion [BRVO] and Central Retinal Vein
    Occlusion [CRVO]).
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
    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.
  • WARNINGS AND
    PRECAUTIONS
  • Intravitreal injections, including those
    with EYLEA, have been associated
    with endophthalmitis and retinal
    detachments. Proper aseptic injection
    technique must always be used when
    administering EYLEA. Patients should
    be instructed to report any symptoms
    suggestive of endophthalmitis or
    retinal detachment without delay and
    should be managed appropriately.
    Intraocular inflammation has been
    reported with the use of EYLEA.
  • Acute increases in intraocular
    pressure have been seen within 60
    minutes of intravitreal injection,
    including with EYLEA. Sustained
    increases in intraocular pressure
    have also been reported after repeated
    intravitreal dosing with VEGF
    inhibitors. Intraocular pressure and
    the perfusion of the optic nerve head
    should be monitored and managed
    appropriately.
  • There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab; through 96 weeks, the incidence was 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.
  • ADVERSE REACTIONS
  • Serious adverse reactions related to
    the injection procedure have occurred
    in <0.1% of intravitreal injections with
    EYLEA including endophthalmitis and
    retinal detachment.
  • 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.
  • Patients may experience temporary
    visual disturbances after an
    intravitreal injection with EYLEA and
    the associated eye examinations.
    Advise patients not to drive or use
    machinery until visual function has
    recovered sufficiently.
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. June 2021.
  2. Heier JS, Brown DM, Chong V, et al; for the
    VIEW 1 and VIEW 2 Study Groups. Intravitreal
    aflibercept (VEGF Trap-Eye) in wet age-
    related macular degeneration. Ophthalmology.
    2012;119(12):2537-2548. doi:10.1016/
    j.ophtha.2012.09.006
  3. Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, et
    al. Intravitreal aflibercept injection for
    neovascular age-related macular
    degeneration: ninety-six-week results of the
    VIEW studies. Ophthalmology.
    2014;121(1):193-201. doi:10.1016/
    j.ophtha.2013.08.011
  4. Brown DM, Schmidt-Erfurth U, Do DV, et al.
    Intravitreal aflibercept for diabetic macular
    edema: 100-week results from the VISTA and
    VIVID studies. Ophthalmology.
    2015;122(10):2044-2052. doi:10.1016/
    j.ophtha.2015.06.017
  5. Campochiaro PA, Clark WL, Boyer DS, et al.
    Intravitreal aflibercept for macular edema
    following branch retinal vein occlusion: the
    24-week results of the VIBRANT study.
    Ophthalmology. 2015;122(3):538-544.
    doi:10.1016/j.ophtha.2014.08.031
  6. Boyer D, Heier J, Brown DM, et al. Vascular
    endothelial growth factor Trap-Eye for
    macular edema secondary to central retinal
    vein occlusion: six-month results of the phase
    3 COPERNICUS study. Ophthalmology.
    2012;119(5):1024-1032. doi:10.1016/
    j.ophtha.2012.01.042
  7. Holz FG, Roider J, Ogura Y, et al. VEGF Trap-
    Eye for macular oedema secondary to central
    retinal vein occlusion: 6-month results of the
    phase III GALILEO study. Br J Ophthalmol.
    2013;97(3):278-284. doi:10.1136/
    bjophthalmol-2012-301504
  8. 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.
  9. Data on file. Regeneron Pharmaceuticals, Inc.