Clinically Significant Vision Gains (15 letters) Across 3 Robust Clinical
Trials in MEfRVO

Over half of patients with Macular Edema following Retinal Vein Occlusion achieved substantial improvements
in visual acuity within 6 months

Proportion of patients who gained ≥15 ETDRS letters at Month 6 from baseline vs control1-4,*

Primary Endpoint. Chart showing proportion of EYLEA-treated patients who gained ≥15 ETDRS letters at Month 6 vs control in VIBRANT, COPERNICUS, and GALILEO trials. 53% vs 27% (VIBRANT), 56% VS 12% (COPERNICUS), 60% vs 22% (GALILEO). P<0.01 vs control and sham control. Primary Endpoint. Chart showing proportion of EYLEA-treated patients who gained ≥15 ETDRS letters at Month 6 vs control in VIBRANT, COPERNICUS, and GALILEO trials. 53% vs 27% (VIBRANT), 56% VS 12% (COPERNICUS), 60% vs 22% (GALILEO). P<0.01 vs control and sham control.

VIBRANT Study Design

Randomized, multicenter, double-masked, controlled study in which patients with MEfBRVO (N=181; age range: 42-94 years, with a mean of 65 years) were randomized to receive: 1) EYLEA 2 mg Q4 or 2) laser photocoagulation administered at baseline and subsequently as needed
(control group).1

The primary efficacy endpoint was the proportion of patients who gained ≥15 letters in BCVA at Week 24 compared with baseline.1

COPERNICUS and GALILEO
Study Designs

Randomized, multicenter, double-masked, sham-controlled studies in patients with MEfCRVO (N=358; age range: 22-89 years, with a mean of 64 years). Patients were assigned in a 3:2 ratio to either: 1) EYLEA 2 mg Q4 for the first 6 months or 2) sham injections (control) Q4 for a total of 6 injections.1

In both studies, the primary efficacy endpoint was the proportion of patients who gained ≥15 letters in BCVA at Week 24 compared with baseline.1

BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks.

Rapid, Sustained Improvements in Visual Acuity

EYLEA led to mean gains of 17 or more ETDRS letters at Month 6 in all 3 pivotal MEfRVO trials

Mean change in BCVA (ETDRS letters) through Month 6 from baseline1,5,*

Chart showing mean change in BCVA (ETDRS ketters) in EYLEA-treated patients through Month 6 from baseline vs control in VIBRANT, COPERNICUS, and GALILEO trials. +17.0 vs +6.9 (VIBRANT), +17.3 vs -4.0 (COPERNICUS), +18.0 vs +3.3 (GALILEO). Chart showing mean change in BCVA (ETDRS ketters) in EYLEA-treated patients through Month 6 from baseline vs control in VIBRANT, COPERNICUS, and GALILEO trials. +17.0 vs +6.9 (VIBRANT), +17.3 vs -4.0 (COPERNICUS), +18.0 vs +3.3 (GALILEO).
Chart showing mean change in BCVA (ETDRS ketters) in EYLEA-treated patients through Month 6 from baseline vs control in VIBRANT, COPERNICUS, and GALILEO trials. +17.0 vs +6.9 (VIBRANT), +17.3 vs -4.0 (COPERNICUS), +18.0 vs +3.3 (GALILEO). Chart showing mean change in BCVA (ETDRS ketters) in EYLEA-treated patients through Month 6 from baseline vs control in VIBRANT, COPERNICUS, and GALILEO trials. +17.0 vs +6.9 (VIBRANT), +17.3 vs -4.0 (COPERNICUS), +18.0 vs +3.3 (GALILEO).
Chart showing mean change in BCVA (ETDRS ketters) in EYLEA-treated patients through Month 6 from baseline vs control in VIBRANT, COPERNICUS, and GALILEO trials. +17.0 vs +6.9 (VIBRANT), +17.3 vs -4.0 (COPERNICUS), +18.0 vs +3.3 (GALILEO). Chart showing mean change in BCVA (ETDRS ketters) in EYLEA-treated patients through Month 6 from baseline vs control in VIBRANT, COPERNICUS, and GALILEO trials. +17.0 vs +6.9 (VIBRANT), +17.3 vs -4.0 (COPERNICUS), +18.0 vs +3.3 (GALILEO).

BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks.

First-line Efficacy Across a Wide Range of Patient Types in MEfRVO1

Patients achieved clinically significant vision gains regardless of having better or worse than 20/200 vision at baseline

Proportion of patients who gained ≥15 ETDRS letters at Month 6 from baseline by baseline BCVA (prespecified subgroup analysis)5,*

Chart showing proportion of EYLEA-treated patients who gained ≥15  ETDRS letters at Month 6 vs control in VIBRANT, COPERNICUS, and GALILEO trials. Patients with >20/200 vision at baseline: 52% vs 27% (VIBRANT), 52% vs 11% (COPERNICUS), 59% vs 21% (GALILEO). Patients with ≤20/200 vision at baseline: 67% vs 29% (VIBRANT), 68% vs 17% (COPERNICUS), 65% vs 25% (GALILEO). Chart showing proportion of EYLEA-treated patients who gained ≥15  ETDRS letters at Month 6 vs control in VIBRANT, COPERNICUS, and GALILEO trials. Patients with >20/200 vision at baseline: 52% vs 27% (VIBRANT), 52% vs 11% (COPERNICUS), 59% vs 21% (GALILEO). Patients with ≤20/200 vision at baseline: 67% vs 29% (VIBRANT), 68% vs 17% (COPERNICUS), 65% vs 25% (GALILEO).

The results of this prespecified subgroup analysis require cautious interpretation and could represent chance findings, as a multiplicity adjustment has not been applied.

Treatment effects in evaluable subgroups in each study were, in general, consistent with the results in the overall populations.1

EYLEA demonstrated clinically significant vision gains regardless of baseline retinal perfusion

Proportion of patients who gained ≥15 ETDRS letters at Month 6 from baseline by perfusion status (prespecified subgroup analysis)5,*

Chart showing proportion of EYLEA-treated patients who gained ≥15 ETDRS letters at Month 6 from baseline vs control in VIBRANT, COPERNICUS, and GALILEO trials. Perfused patients: 44% vs 24% (VIBRANT), 58% vs 16% (COPERNICUS), 58% vs 26% (GALILEO). Nonperfused patients: 60% vs 38% (VIBRANT), 51% vs 4% (COPERNICUS), 71% vs 7% (GALILEO). Chart showing proportion of EYLEA-treated patients who gained ≥15 ETDRS letters at Month 6 from baseline vs control in VIBRANT, COPERNICUS, and GALILEO trials. Perfused patients: 44% vs 24% (VIBRANT), 58% vs 16% (COPERNICUS), 58% vs 26% (GALILEO). Nonperfused patients: 60% vs 38% (VIBRANT), 51% vs 4% (COPERNICUS), 71% vs 7% (GALILEO).

The results of this prespecified subgroup analysis require cautious interpretation and could represent chance findings, as a multiplicity adjustment has not been applied.

Treatment effects in evaluable subgroups in each study were, in general, consistent with the results in the overall populations.1

BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks.

Earlier Treatment With EYLEA Led to Increased Vision Gains in MEfCRVO

A higher proportion of patients achieved significant vision gains when treated within 2 months of diagnosis

Proportion of patients who gained ≥15 ETDRS letters at Month 6 from baseline by time to treatment initiation (protocol-specified subgroup analysis)5,*

Chart showing proportion of EYLEA treated patients who gained ≥15 ETDRS letters at Month 6 from baseline vs control in COPERNICUS and GALILEO trials. Patients treated at <2months from diagnosis: 69% vs 15% (COPERNICUS), 71% vs 20% (GALILEO). Patients treated at ≥2 months from diagnosis: 39% vs 5% (COPERNICUS), 50% vs 24% (GALILEO) Chart showing proportion of EYLEA treated patients who gained ≥15 ETDRS letters at Month 6 from baseline vs control in COPERNICUS and GALILEO trials. Patients treated at <2months from diagnosis: 69% vs 15% (COPERNICUS), 71% vs 20% (GALILEO). Patients treated at ≥2 months from diagnosis: 39% vs 5% (COPERNICUS), 50% vs 24% (GALILEO)

ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks.

CRT data with EYLEA2-4

Available in a
single-dose–strength PFS1

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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. March 2021.
  2. Campochiaro PA, Clark WL, Boyer DS, et al. lntravitreal 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
  3. 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
  4. 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
  5. Data on file. Regeneron Pharmaceuticals, Inc.