Treat with foresight
DME

DME

TREAT WITH FORESIGHT—for unsurpassed and lasting vision gains1,2,3-5

VA GAINS

Superior VA gains driven by patients with baseline BCVA <69 letters3-7,a

  • Superior VA gains in Year 1 vs ranibizumab
  • Superior average VA gains over 2 years vs ranibizumab
RAPID AND CONTINUOS VA GAINS

Rapid and continuous VA gains2,3,8

  • Clinically significant vision gains from the first dose (>5 letters)
  • Continuous vision gains with all 5 initiation doses
MOA

Mechanism of Action

Unique multi-targeted trap is the only DME anti-VEGF that blocks all VEGFR-1 ligands, including VEGF and PGF (which when elevated correlate to severity of diabetic eye disease)9-12

EYLEA IS THE EURETINA GUIDELINES DME DRUG OF CHOICE IN PATIENTS WITH BASELINE BCVA <69 LETTERS5,6,a,b

Mean change in VA over time according to baseline VA3,6

MEAN CHANGE

EYLEA (+18.9) vs ranibizumab (+14.2): +4.7 letters; P=0.0003

EYLEA (+18.9) vs bevacizumabc(+11.8): +7.1 letters; P=0.0001

2 mg EYLEA

0.3 mg ranibizumab

125 mg bevacizumab

A Cochrane network meta-analysis demonstrated that5,6,d:

  • DME patients are 30% more likely to gain ≥3 lines with EYLEA vs ranibizumab in Year 1
  • Greater average vision gains observed with EYLEA vs ranibizumab in Year 1

At Year 1, EYLEA demonstrated superiority vs ranibizumab in patients with baseline BCVA <69 letters6,7

SUPERIOR AVERAGE VISION GAINS OVER 2 YEARS IN PATIENTS WITH BASELINE BCVA <69 LETTERS3-7,a,c

Mean change in VA area under the curve with baseline BCVA <69 letters (<20/40) DRCR.net Protocol T cohort (posthoc analysis)3,4

MEAN CHANGE

EYLEA (+17.1) vs ranibizumab (+13.6): +3.4 letters; P=0.009

EYLEA (+17.1) vs bevacizumabc (+12.1): +4.5 letters; P<0.001

2 mg EYLEA

0.3 mg ranibizumab

125 mg bevacizumab

 

    UNSURPASSED VISION GAINS SUSTAINED OVER 2 YERARS WITH EYLEA3,4

    Mean change in BCVA over time - DRCR.net Protocol T cohort3,5-7,a,c

    Mean change

    2 mg EYLEA

    0.3 mg ranibizumab

    125 mg bevacizumab

    Significantly higher laser requirement with ranibizumab may have contributed to the loss of superiority in vision gains with EYLEA at 2 years.3,e

    VIVID DME

    TREAT WITH FORESIGHT-WITH RAPID, CONTINUOUS VA GAINS FROM THE START2,3,f

    VIVID: Mean change in BCVA through Week 52

    VIVID MEAN CHANGE

    EYLEA ®2 mg administered every month (4 weeks) for the first 5 months, followed by once every 2 months (n=135)

    Laser photocoagulation administered as needed, no more often than every 12 weeks (n=132)

    In VIVID and VISTA, EYLEA demonstrated rapid, clinically significant vision gains (>5 letters) and continuous gains with all 5 initiation doses.1, 2, 8, 13, 14

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    • In Protocol T, the dose of ranibizumab tested was 0.3 mg (US-approved dosage), while the ex-US dosage of ranibizumab is 0.5 mg. The treatment regimen tested in Protocol T was not the label regimen for either EYLEA or ranibizumab.
    • The EURETINA Guidelines included data from Protocol T where the dose of ranibizumab tested was 0.3 mg (US-approved dosage), while the ex-US dosage of ranibizumab is 0.5 mg. The treatment regimen tested in Protocol T was not the label regimen for either EYLEA or ranibizumab.
    • Bevacizumab has no marketing authorization for use in ophthalmic indications.
    • Meta-analysis using Cochrane methods (based on a search of databases conducted in April 2017) of RCTs with anti-VEGF agents in DME patients, focused on the three most commonly used drugs: EYLEA, ranibizumab, and unlicensed bevacizumab. The analysis included 24 studies and 6007 participants in total. A total of 17 studies (4031 eyes) were assessed for gains of 3 or more VA lines at one year. This Cochrane meta-analysis included data from Protocol T where the dose of ranibizumab tested was 0.3 mg (US-approved dosage) while the ex-US dosage of ranibizumab is 0.5 mg. The treatment regimen tested in Protocol T was not the label regimen for either EYLEA or ranibizumab.
    • Pairwise comparisons (adjusted for multiple comparisons) over 2 years: ranibizumab (52%) vs EYLEA (41%; P=0.04)
    • In the VIVID and VISTA RCTs patients were randomized to receive EYLEA 2 mg either every 4 or 8 weeks after 5 monthly doses, or laser control. From Week 24, if rescue treatment criteria were met, EYLEA patients received active laser, and laser control patients received 5 monthly doses of EYLEA, followed by dosing every 8 weeks. From Week 100, laser control patients who had not received EYLEA rescue treatment received EYLEA as needed per retreatment criteria.

    References:

    • EYLEA ® (aflibercept solution for injection) Summary of Product Characteristics. Berlin, Germany: Bayer Pharma AG.
    • A Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121:2247-2254.
    • Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema: two-year results from a comparative effectiveness randomized clinical trial. Ophthalmology. 2016;123:1351-1359.
    • Jampol LM, Glassman AR, Bressler NM, Wells JA, Ayala AR; for the Diabetic Retinopathy Clinical Research Network. Anti-vascular endothelial growth factor comparative effectiveness trial for diabetic macular edema: additional efficacy post hoc analyses of a randomized clinical trial. JAMA Ophthalmol. 2016;134:1429-1434.
    • Virgili G, Parravano M, Evans JR, Gordon I, Lucenteforte E. Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis (review).Cochrane Database Syst Rev. 2017;6:CD007419.pub5.
    • Schmidt-Erfurth U, Garcia-Arumi J, Bandello F, et al. Guidelines for the management of diabetic macular edema by the European Society of Retina Specialists (EURETINA). Ophthalmologica. 2017;237:185-22.pub5.
    • Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015;372:1193-1203.
    • Ziemssen F, Schlottman PG, Lim JI, Agostini H, Lang GE, Bandello F. Initiation of intravitreal aflibercept injection treatment in patients with diabetic macular edema: a review of VIVID‑DME and VISTA‑DME data. Int J Retina Vitreous. 2016;2:16.
    • Papadopoulos N, Martin J, Ruan Q, et al. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap,ranibizumab and bevacizumab. Angiogenesis. 2012;15;171-185.
    • Krizova L, Kalousova M, Kubena AA, et al. Correlation of vitreous vascular endothelial growth factor and uric acid concentration using optical coherence tomography in diabetic macular edema. J Ophthalmol. 2015;478509.
    • Al Kahtani E, Xu Z, Al Rashead S, et al. Vitreous levels of placental growth factor correlate with activity of proliferative diabetic retinopathy and are not influenced by bevacizumab treatment. Eye (Lond). 2017;31:529-536.
    • Nguyen QD, De Falco S, Behar-Cohen F, et al. Placental growth factor and its potential role in diabetic retinopathy and other ocular neovascular diseases. Acta Ophthalmol. 2018;96:e1-e9.
    • Heier JS, Korobelnik JF, Brown DM, et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies.Ophthalmology. 2016;123:2376-2385.
    • 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;122:2044-2052.

    This website contains information on EYLEA® (aflibercept solution for injection) which is based on the Summary of Product Characteristics (SPC) as approved by the European Commission. It is intended to provide information to an international audience outside the USA and UK. In countries outside the EU the local Product Information applies.

    PP-EYL-ALL-0513-1. Last updated on 29/02/2020