Power With EYLEA—Regardless of Studied Baseline Visual Acuity1

Whether patients presented with better or worse baseline vision, EYLEA demonstrated powerful results in patients with Wet AMD at 52 weeks, DME at 52 and 100 weeks, and Macular Edema following RVO at 24 weeks.1 Results are presented by prespecified subgroups of baseline visual acuity.1


DME—Visual acuity gains at 100 weeks across visual acuity subgroups1

  • Primary efficacy endpoint in the VISTA and VIVID trials: Mean change in BCVA, as Measured by ETDRS letters, at 52 weeks vs baseline. See primary endpoint results.
Mean Change in BCVA by Baseline Visual Acuity Category,* as Measured by ETDRS Letters, vs Baseline at 100 Weeks (prespecified subgroup analysis)1
Graph showing diabetic macular edema patients visual acuity gains at 100 weeks across baseline visual acuity subgroups Graph showing diabetic macular edema patients visual acuity gains at 100 weeks across baseline visual acuity subgroups
  • Similar results were seen at 100 weeks in VIVID.1

VISTA and VIVID study designs: Two randomized, multicenter, double-masked, controlled studies in which patients with DME (N=862; age range: 23-87 years with a mean of 63 years) were randomized and received 1) EYLEA® (aflibercept) Injection 2 mg administered every 8 weeks following 5 initial monthly doses; 2) EYLEA 2 mg administered every 4 weeks; or 3) macular laser photocoagulation (control), at baseline and then as needed.

In both studies, the primary efficacy endpoint was the mean change from baseline in best-corrected visual acuity at week 52 as measured by Early Treatment Diabetic Retinopathy Study letter score.

  • *Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Following 5 initial monthly doses.

Wet AMD—Percentage of patients who maintained vision at 52 weeks for all visual acuity subgroups1

  • Primary efficacy endpoint in the VIEW trials–Proportion of patients who maintained vision (<15 letters lost) at week 52 vs baseline. See primary endpoint results.
% Patients Who Maintained Vision (<15 letters lost) Based on Baseline BCVA by Baseline Visual Acuity Category,* as Measured by ETDRS Letters, at 52 Weeks (prespecified subgroup analysis)1
Graph showing percentage of wet macular degeneration patients who maintained vision based on baseline BCVA, as measured by ETDRS Graph showing percentage of wet macular degeneration patients who maintained vision based on baseline BCVA, as measured by ETDRS
  • Treatment effects in evaluable subgroups in each study were in general consistent with the results in the overall populations.

VIEW 1 and VIEW 2 study designs: Two multicenter, double-masked studies in which patients with Wet AMD (N=2412; age range: 49-99 years with a mean of 76 years) were randomized to receive 1) EYLEA® (aflibercept) Injection 2 mg administered every 8 weeks following 3 initial monthly doses every 4 weeks; 2) EYLEA 2 mg administered every 4 weeks; 3) EYLEA 0.5 mg administered every 4 weeks; or 4) ranibizumab 0.5 mg administered every 4 weeks.

In both studies, the primary efficacy endpoint was the proportion of patients who maintained vision, defined as losing fewer than 15 letters of visual acuity at week 52 compared to baseline.

  • *Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Following 3 initial monthly doses.

Macular Edema following RVO—Gains of ≥3 lines (≥15 letters of vision*) in both baseline visual acuity subgroups at week 241

  • Primary efficacy endpoint in the VIBRANT, COPERNICUS, and GALILEO trials–% patients who gained ≥15 ETDRS letters at 24 weeks from baseline. See primary endpoint results.
% 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)1
Graph showing percentage of macular edema following retinal vein occlusion patients who gained greater than or equal to 15 letters based on baseline BCVA, as measured by ETDRS Graph showing percentage of macular edema following retinal vein occlusion patients who gained greater than or equal to 15 letters based on baseline BCVA, as measured by ETDRS
  • Treatment effects in evaluable subgroups in each study were in general consistent with the results in the overall populations.

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® (aflibercept) Injection 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® (aflibercept) Injection 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.
  • Early Treatment Diabetic Retinopathy Study.
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Important Safety Information and Indications
  • 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 Important Prescribing Information

EYLEA® (aflibercept) Injection is indicated for the treatment of patients with

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.

Reference
  1. Data on file. Regeneron Pharmaceuticals, Inc.