Clinically Significant Improvement of ≥3 lines (≥15 Letters of Vision*) Seen Across All Indications Studied1

A proportion of EYLEA patients gained 3 or more lines (≥15 letters of vision*) across all pivotal studies of patients with Wet AMD at 52 weeks, MEfCRVO at 24 weeks, and DME at 52 and 100 weeks.1


Wet AMD—Improvement of ≥3 lines at 52 weeks to a 95.1% confidence interval1

  • Primary efficacy endpoint in the VIEW trials: in both studies, the primary efficacy endpoint was the proportion of patients who maintained vision, defined as losing ≤15 letters of visual acuity at week 52 compared to baseline. See primary endpoint results.
% Patients Who Gained ≥15 ETDRS Letters at 52 Weeks From Baseline vs Control (secondary endpoint)1,†
Graph comparing Wet AMD visual improvements with EYLEA versus control. Graph comparing Wet AMD visual improvements with EYLEA versus control.

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 as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
  • Last observation carried forward; full analysis set.
  • Following 3 initial monthly doses.

DME—Significant visual improvement of ≥3 lines at 52 and 100 weeks1,2

  • 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.
% Patients Who Gained ≥15 ETDRS Letters at 52 and 100 Weeks From Baseline vs Control (secondary endpoint)1,†
Graph comparing diabetic macular edema visual improvements with EYLEA versus control. 52 weeks VISTA and VIVID. 100 weeks VISTA and VIVID. Graph comparing diabetic macular edema visual improvements with EYLEA versus control. 52 weeks VISTA and VIVID. 100 weeks VISTA and VIVID.

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, as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
  • Last observation carried forward; full analysis set.
  • §Following 5 initial monthly doses.

Macular Edema following RVO—The majority of patients had significant visual acuity improvement of ≥3 lines lines at 24 weeks1

% Patients Who Gained ≥15 ETDRS Letters at 24 Weeks From Baseline vs Control (primary endpoint)1,†
Graph comparing macular edema following retinal vein occlusion visual improvements with EYLEA versus control. Graph comparing macular edema following retinal vein occlusion visual improvements with EYLEA versus control.

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 as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
  • Last observation carried forward; full analysis set.
Mean Change in BCVA,* as Measured by ETDRS Letters, at 24 Weeks vs Baseline (secondary endpoint)1,†
VIBRANT (MEfBRVO) plus 17.0 with EYLEA (n=91), plus 6.9 with control (n=90). Copernicus (MEfCRVO) plus 17.3 with EYLEA (n=114), minus 4.0 with sham control (n=73). GALILEA (MEfCRVO) plus 18.0 with EYLEA (n=103), plus 3.3 with sham control (n=68). VIBRANT (MEfBRVO) plus 17.0 with EYLEA (n=91), plus 6.9 with control (n=90). Copernicus (MEfCRVO) plus 17.3 with EYLEA (n=114), minus 4.0 with sham control (n=73). GALILEA (MEfCRVO) plus 18.0 with EYLEA (n=103), plus 3.3 with sham control (n=68).
  • *Best-corrected visual acuity as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
  • Last observation carried forward; full analysis set.
Importance of intervention

While the acute process of BRVO may resolve, the presence of macular edema is a common cause of visual dysfunction and poor visual prognosis2,3

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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.

References
  1. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. May 2017.
  2. American Academy of Ophthalmology. Preferred Practice Pattern®: Retinal Vein Occlusions. http://bit.ly/2l3WW7J. Accessed June 23, 2017.
  3. Rehak M, Wiedemann P. Retinal vein thrombosis: pathogenesis and management. J Thromb Haemost. 2010;8(9):1886-1894.