Eylea Indication DME

DME

TREAT WITH FORESIGHT—for unsurpassed and lasting vision gains.^,^,^,^,

Superior VA gains driven by patients with baseline BCVA < 69 letters

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Superior VA gains in Year 1 vs ranibizumab.
Superior average VA gains over 2 years vs ranibizumab.

Rapid and continuous VA gains

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

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).^,^,^,

EYLEA
®
2mg IS THE EURETINA GUIDELINES DME DRUG OF CHOICE IN PATIENTS WITH BASELINE BCVA < 69 LETTERS
^,^,^,

Mean change in VA over time according to baseline VA.^,

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

EYLEA® (+18.9) vs bevacizumab(+11.8): +7.1 letters; P=0.0001.

2mg EYLEA®
0.3 mg ranibizumab
125 mg bevacizumab

A Cochrane network meta-analysis demonstrated that

^,^,:

DME patients are
30% more likely to gain ≥3 lines with EYLEA® 2mg
vs ranibizumab in Year 1.
Greater average vision gains observed with EYLEA® 2mg vs ranibizumab in Year 1.

At Year 1, EYLEA

® 2mg demonstrated superiority vs ranibizumab in patients with baseline BCVA < 69 letters.
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SUPERIOR AVERAGE VISION GAINS OVER 2 YEARS IN PATIENTS WITH BASELINE BCVA < 69 LETTERS
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Mean change in VA area under the curve with baseline BCVA <69 letters (<20/40) DRCR.net Protocol T cohort (posthoc analysis).^,

EYLEA® 2mg (+17.1) vs ranibizumab (+13.6): +3.4 letters; P=0.009.

EYLEA® 2mg (+17.1) vs bevacizumabc (+12.1): +4.5 letters; P < 0.001.

2mg EYLEA®
0.3 mg ranibizumab
125 mg bevacizumab

PROTOCOL T FULL COHORT

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

TREAT WITH FORESIGHT-WITH RAPID, CONTINUOUS VA GAINS FROM THE START
^,^,

VIVID: Mean change in BCVA through Week 52.

EYLEA® 2mg 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

® 2mg demonstrated rapid, clinically significant vision gains (>5 letters) and continuous gains with all 5 initiation doses.
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DOSING

Pro-active dosing options across indications

MOA

Unique multi-targeted trap mechanism^,

EYLEA® 2mg PRE-FILLED SYRINGE

WHAT'S INSIDE MAKES THE DIFFERENCE

Syringe cap with a simple twist mechanism, for controlled opening

LEARN MORE

PP-EYL-IL-0128-1

References

1
EYLEA® 2mg updated SPC as approved by the Israeli MoH.
2
A Korobelnik JF, Do DV, Schmidt-Erfurth U,
et al
. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121:2247-2254.
3
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.
4
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.
5
Virgili G, Parravano M, Evans JR, Gordon I, Lucenteforte E. Anti-vascular endothelial growth factor for diabetic macular edema: a network meta-analysis (review).Cochrane Database Syst Rev. 2017;6:CD007419.pub5.
6
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.
7
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.
8
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.
9
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.
10
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.
11
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.
12
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.
13
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.
14
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.

Footnotes

a
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® 2mg or ranibizumab.
b
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® 2mg or ranibizumab.
c
Bevacizumab has no marketing authorization for use in ophthalmic indications.
d
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® 2mg, 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® 2mg or ranibizumab.
e
Pairwise comparisons (adjusted for multiple comparisons) over 2 years: ranibizumab (52%) vs EYLEA® 2mg (41%; P=0.04).
f
In the VIVID and VISTA RCTs patients were randomized to receive EYLEA® 2mg either every 4 or 8 weeks after 5 monthly doses, or laser control. From Week 24, if rescue treatment criteria were met, EYLEA® 2mg patients received active laser, and laser control patients received 5 monthly doses of EYLEA® 2mg, followed by dosing every 8 weeks. From Week 100, laser control patients who had not received EYLEA® 2mg rescue treatment received EYLEA® 2mg as needed per retreatment criteria.