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.

*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,*

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).

*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,*

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

*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,*

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

*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,*

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)

*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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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.