Clinically Significant Improvement of ≥3 lines (≥15 Letters of Vision*) Seen in MEfRVO1

A proportion of EYLEA patients gained 3 or more lines (≥15 letters of vision*) across all pivotal studies of patients with MEfRVO at 24 weeks.1

MEfRVO—The majority of patients had significant visual acuity improvement of ≥3 lines at 24 weeks1

% Patients Who Gained ≥15 ETDRS Letters at 24 Weeks From Baseline vs Control (primary endpoint)1,†

Chart showing  % patients who gained ≥15 ETDRS letters at 24 weeks in the VIBRANT, COPERNICUS, and GALILEO studies. Chart showing  % patients who gained ≥15 ETDRS letters at 24 weeks in the VIBRANT, COPERNICUS, and GALILEO studies.

VIBRANT study design: Randomized, multicenter, double-masked, controlled study in which patients with Macular Edema following BRVO (N=181; age range: 42-94 years, with a mean of 65 years) were randomized to receive 1) EYLEA 2 mg administered every 4 weeks or 2) laser photocoagulation administered at baseline and subsequently as needed (control group).

The primary efficacy endpoint was the proportion of patients who gained at least 15 letters in best-corrected visual acuity at week 24 compared to baseline.

COPERNICUS and GALILEO study designs: Randomized, multicenter, double-masked, sham-controlled studies in patients with Macular Edema following CRVO (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 administered every 4 weeks (monthly) for the first 6 months or 2) sham injections (control) administered every 4 weeks (monthly) for a total of 6 injections.

In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters in best-corrected visual acuity at week 24 compared to baseline.

  • *Best-corrected visual acuity, as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
  • Last observation carried forward; full analysis set.
Sustained Improvement in Visual Acuity Over 24 Weeks1

EYLEA demonstrated powerful visual acuity results in patients with MEfRVO at 24 weeks.1

Mean Change in BCVA,* as Measured by ETDRS Letters, at 24 Weeks vs Baseline1,‡
Graph showing mean change in BCVA as measured by ETDRS letters at 24 weeks in the MEfBRVO VIBRANT study. Graph showing mean change in BCVA as measured by ETDRS letters at 24 weeks in the MEfBRVO VIBRANT study.
Graph showing mean change in BCVA as measured by ETDRS letters at 24 weeks in the MEfCRVO COPERNICUS study. Graph showing mean change in BCVA as measured by ETDRS letters at 24 weeks in the MEfCRVO COPERNICUS study.
Graph showing mean change in BCVA as measured by ETDRS letters at 24 weeks in the MEfCRVO GALILEO study. Graph showing mean change in BCVA as measured by ETDRS letters at 24 weeks in the MEfCRVO GALILEO study.

  • *Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Last observation carried forward; full analysis set.

Start With EYLEA—Regardless of Baseline Visual Acuity Studied2,*

Whether patients presented with better or worse baseline vision, EYLEA demonstrated powerful results in patients with MEfRVO at 24 weeks.2 Results are presented by prespecified subgroups of baseline visual acuity.2

% Patients Who Gained ≥15 Letters Based on Baseline BCVA by Baseline Visual Acuity Category,* as Measured by ETDRS Letters, at 24 Weeks (prespecified subgroup analysis)2
Chart showing % patients gaining ≥15  letters based on baseline BCVA by baseline visual acuity category in the VIBRANT, COPERNICUS and GALILEO studies. Chart showing % patients gaining ≥15  letters based on baseline BCVA by baseline visual acuity category in the VIBRANT, COPERNICUS and GALILEO studies.

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

  • *Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.

Start EYLEA first-line. EYLEA demonstrated powerful results in patients with MEfCRVO at 24 weeks2—all of whom were anti-VEGF-treatment-naïve3,4

MEfCRVO—Earlier intervention may lead to better patient outcomes2
% Patients Gaining ≥15 ETDRS* Letters at 24 Weeks by Time to Treat From Baseline (protocol-specified subgroup analysis)2,†
Chart showing % patients gaining ≥15 ETDRS letters at 24 weeks by time to treatment from baseline in the COPERNICUS and GALILEO studies. Chart showing % patients gaining ≥15 ETDRS letters at 24 weeks by time to treatment from baseline in the COPERNICUS and GALILEO studies.

Early intervention may help improve outcomes2,5-7
  • Several pivotal studies showed that patients receiving delayed treatment for MEfCRVO never attained the visual improvement of patients receiving earlier treatment5-7
  • In the COPERNICUS and GALILEO protocol-specified subgroup analysis, visual acuity improvements were quantitatively larger in patients treated within 2 months of diagnosis vs patients treated 2 or more months after diagnosis2

  • anti-VEGF = anti–vascular endothelial growth factor.
  • *Early Treatment Diabetic Retinopathy Study.
  • Last observation carried forward; full analysis set.
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See More Important Safety Information and Indications
  • CONTRAINDICATIONS: EYLEA® (aflibercept) Injection 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. August 2019.
  2. Data on file. Regeneron Pharmaceuticals, Inc.
  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.
  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.
  5. Campochiaro PA, Brown DM, Awh CC, et al. Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study. Ophthalmology. 2011;118(10):2041-2049.
  6. Haller JA, Bandello F, Belfort R Jr, et al; for the Ozurdex GENEVA Study Group. Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results. Ophthalmology. 2011;118(12):2453-2460.
  7. Brown DM, Heier JS, Clark WL, et al. Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1-year results from the phase 3 COPERNICUS study. Am J Ophthalmol. 2013;155(3):429-437.e7.