Start With EYLEA

Start EYLEA first-line. EYLEA demonstrated powerful results in patients with Wet AMD at 52 weeks, DME at 52 and 100 weeks, DR in Patients with DME at 100 weeks, and Macular Edema following CRVO at 24 weeks–all or most of whom were anti-VEGF-treatment-naïve.1-3


First-line* for Wet AMD—On average, visual acuity gains achieved during the initial response period were sustained through 52 weeks1

  • All patients in VIEW 1 and VIEW 2 were naïve to anti-VEGF treatment.2
  • Primary efficacy endpoint in the VIEW trials–proportion of patients who maintained vision (<15 letters lost) at 52 weeks vs baseline. See primary endpoint results.
Mean Change in BCVA, as Measured by ETDRS Letters, vs Baseline at 52 weeks (secondary endpoint)1,§ 
Graph comparing EYLEA to ranibizumab in Wet AMD patients showing ETDRS letters gained over 52 weeks for VIEW 1 and VIEW 2. Graph comparing EYLEA to ranibizumab in Wet AMD patients showing ETDRS letters gained over 52 weeks for VIEW 1 and VIEW 2.

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.

  • *First-line anti–vascular endothelial growth factor (anti-VEGF) treatment in VIEW 1 and VIEW 2.
  • Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • §Last observation carried forward; full analysis set.
  • Following 3 initial monthly doses.

Wet AMD Patients With Early Persistent Retinal Fluid at 52 weeks. A post hoc analysis of the VIEW trials3

Mean Change in BCVA,* as Measured by ETDRS Letters, Over 52 Weeks vs Baseline (VIEW 1 and VIEW 2 post hoc analysis)3
Graph showing ETDRS Letters change. Plus 11.7 for EYLEA 2 mg every 4 weeks (n=115). Plus 7.5 for EYLEA 2 mg every 8 weeks (n=123). Graph showing ETDRS Letters change. Plus 11.7 for EYLEA 2 mg every 4 weeks (n=115). Plus 7.5 for EYLEA 2 mg every 8 weeks (n=123).
  • Primary efficacy endpoint in the VIEW trials–proportion of patients who maintained vision (<15 letters lost) at 52 weeks vs baseline.
  • Early persistent fluid was defined as retinal fluid (intraretinal [cystic] or subretinal) at baseline and after 3 initial monthly anti-VEGF§ injections as seen on time-domain OCT.3,II
  • ≈20% of Wet AMD patients treated with EYLEA experienced early persistent retinal fluid.3
  • *Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Following 3 initial monthly doses.
  • §Anti–vascular endothelial growth factor.
  • IIOptical coherence tomography.

First-line* in DME—On average, visual acuity gains achieved during the initial response period were sustained through 100 weeks2

  • EYLEA patients who were anti-VEGF-naïve at baseline—57% in VISTA; 91% in VIVID.2
  • Primary efficacy endpoint in the VISTA and VIVID trails: Mean change in BCVA, as measured by ETDRS letters, at 52 weeks vs baseline. See primary endpoint results.
Mean Change in BCVA, as Measured by ETDRS Letters, at 100 Weeks vs Baseline in Anti-VEGF-Naïve Patients (post hoc, exploratory subgroup analysis)2
EYLEA 2 mg every 8 weeks - VISTA 11.3, VIVID 8.9. EYLEA 2 mg every 4 weeks - VISTA 12.0, VIVID 11.2. Control - VISTA 2.1, VIVID 0.8. EYLEA 2 mg every 8 weeks - VISTA 11.3, VIVID 8.9. EYLEA 2 mg every 4 weeks - VISTA 12.0, VIVID 11.2. Control - VISTA 2.1, VIVID 0.8.
  • Treatment effects in evaluable subgroups in each study were in general consistent with the results in the overall populations.

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.

  • *First-line anti–vascular endothelial growth factor (anti-VEGF) treatment in the majority of patients in VISTA and VIVID.
  • Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • §Following 5 initial monthly doses.

DR in Patients with DME—Significant improvement in DR severity at 100 weeks1

  • Primary efficacy endpoint in the VISTA and VIVID trials--Mean change in BCVA, as measured by ETDRS letters, at 52 weeks vs baseline.
VISTA and VIVID Efficacy Results at 100 Weeks (secondary endpoint): % Patients Achieving a ≥2-Step Improvement in the ETDRS-DRSS* vs Control1,†
EYLEA for DR in Patients with DME vs control graph showing percentage of patients achieving a greater than 2-step improvement in the ETDRS. EYLEA for DR in Patients with DME vs control graph showing percentage of patients achieving a greater than 2-step improvement in the ETDRS.
  • *Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale: an established grading scale for measuring the severity of DR.
  • Last observation carried forward consists of patients with a baseline fundus photo.
  • IIFollowing 5 initial monthly doses.

Macular Edema following CRVO—Earlier intervention may lead to better patient outcomes2

  • All patients in COPERNICUS and GALILEO were anti-VEGF*-naïve.2
  • Primary efficacy endpoint in the COPERNICUS and GALILEO trials: % patients gaining ≥15 letters at 24 weeks from baseline vs control. See primary endpoint results.
% Patients Gaining ≥15 ETDRS Letters at 24 Weeks by Time to Treat From Baseline (protocol-specified subgroup analysis)2,‡
Graph showing COPERNICUS and GALILEA time to treatment for EYLEA versus sham control. Graph showing COPERNICUS and GALILEA time to treatment for EYLEA versus sham control.

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.

  • *Anti–vascular endothelial growth factor.
  • Early Treatment Diabetic Retinopathy Study.
  • Last observation carried forward; full analysis set.
Early intervention can drive outcome potential2,5-7

Several pivotal studies showed that patients receiving delayed treatment for Macular Edema following CRVO 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

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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. Data on file. Regeneron Pharmaceuticals, Inc.
  3. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-2254.
  4. Jaffe GJ, Kaiser PK, Thompson D, et al. Differential response to anti-VEGF regimens in age-related macular degeneration patients with early persistent retinal fluid. Ophthalmology. 2016;123(9):1856-1864.
  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.