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,*

EYLEA® vision gains across Vibrant, Copernicus, and Galileo clinical trials, Chart EYLEA® vision gains across Vibrant, Copernicus, and Galileo clinical trials, Chart

*Last observation carried forward; full analysis set.

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,*

Mean change in BCVA in Vibrant study, Chart Mean change in BCVA in Vibrant study, Chart
Mean change in BCVA in Copernicus study, Chart Mean change in BCVA in Copernicus study, Chart
Mean change in BCVA in Galileo study, Chart Mean change in BCVA in Galileo study, Chart

*Last observation carried forward; full analysis set.

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,*

EYLEA® vision gains efficacy, Chart EYLEA® vision gains efficacy, Chart

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

*Last observation carried forward; full analysis set.

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,*

EYLEA® vision gains regardless of baseline retinal perfusion, Chart EYLEA® vision gains regardless of baseline retinal perfusion, Chart

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

*Last observation carried forward; full analysis set.

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,*

EYLEA® vision gains when treated within 2 months of diagnosis, Chart EYLEA® vision gains when treated within 2 months of diagnosis, Chart

*Last observation carried forward; full analysis set.

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

CRT data with EYLEA2-4

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Available in a
single-dose–strength PFS1

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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.