Eylea Indication RVO

RVO

EYLEA® 2mg: TREAT WITH FORESIGHT

Unsurpassed vision gains

EYLEA® 2mg achieved unsurpassed vision gains with significantly fewer injections vs ranibizumab and bevacizumab at Week 100.^,^,^,

Rapid benefits

In the COPERNICUS study, patients treated with EYLEA® 2mg gained ≥25 letters vs sham when treated within 2 months of diagnosis.

Proactive extended dosing

In the Casselholm study (n=43), EYLEA® 2mg significantly reduced injection frequency by 24% vs ranibizumab.

EYLEA
®
2mg ACHIEVED UNSURPASSED VISION GAINS WITH SIGNIFICANTLY FEWER INJECTIONS VS RANIBIZUMAB AND BEVACIZUMAB AT WEEK 100^,^,^,

Primary end point: change from baseline in BCVA at Week 100.

EYLEA® 2mg
Ranibizumab
Bevacizumab

The difference in mean number of injections with EYLEA
®
2mg was statistically significant at Weeks 24, 52, and 100 vs ranibizumab.

In a post hoc analysis, EYLEA® 2mg demonstrated significantly fewer injections vs bevacizumab at Week 100.

Rapid vision gains with EYLEA® 2mg of 13.4 letters vs 11.4 for ranibizumab and 10.4 for bevacizumab at Week 24.
52% of EYLEA® 2mg-treated patients gained ≥15 letters vs 47% for ranibizumab and 45% for bevacizumab at Week 100.

Study Design

LEAVO was a multicenter, prospective, 3-arm, double-masked, randomized, noninferiority trial of anti-VEGF monotherapies in CRVO-related macular edema at 100 weeks.

UNSURPASSED VISION GAIN: ≥25 LETTERS VS SHAM WHEN TREATED WITHIN 2 MONTHS OF DIAGNOSIS

UNSURPASSED VA GAINS WITH SUPERIOR DURABILITY

MEAN BCVA GAIN AT 18 MONTHS (P < 0.05)

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.

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References

1
Hykin P, Prevost AT, Vasconcelos JC,
et al
; for the LEAVO study group. Clinical effectiveness of intravitreal therapy with ranibizumab vs aflibercept vs bevacizumab for macular edema secondary to central retinal vein occlusion. JAMA Ophthalmol. Published online first August 29, 2019. doi:10.1001/jamaophthalmol.2019.
2
Boyer D, Heier J, Brown DM,
et al
. Vascular endothelial growth factor trap-eye for macular edema secondary to central retinal vein occlusion. Ophthalmology. 2012;119:1024-1032.
3
Casselholm de Salles M, Amrén U, Kvanta A, Epstein DL. Injection frequency of aflibercept versus ranibizumab in a treat-and-extend regimen for central retinal vein occlusion: a randomized clinical trial. Retina. 2018:1-7. doi: 10.1097/IAE.0000000000002171.
4
EYLEA® 2mg SmPC as approved by the Israeli MoH.

Footnotes

a
At Week 100, EYLEA® 2mg demonstrated an ITT-adjusted mean BCVA difference of 2.23 letters vs ranibizumab (95% CI, –2.17 to 6.63 letters; P
b
Statistically significantly fewer injections vs ranibizumab and bevacizumab at 100 weeks.
c
Exploratory post-hoc analysis vs bevacizumab: EYLEA® 2mg was unlicensed during the study design period, therefore it was considered to be an investigative agent and comparisons with bevacizumab were post hoc.Bevacizumab has no marketing authorization for use in ophthalmic indications.
d
In the COPERNICUS RCT, CRVO patients were randomized to receive EYLEA® 2mg or sham injections every 4 weeks up to Week 24. From Week 24 to 52, all patients were evaluated monthly and received EYLEA® 2mg as needed (PRN). From Weeks 52 to 100, all patients were evaluated at least quarterly and received EYLEA® 2mg PRN. Patients could be evaluated and dosed as frequently as every 4 weeks.
e
Visual outcomes in terms of mean change in BCVA from baseline in the entire cohort, ITT population (n=43). No significant difference between treatment groups.