EYLEA Achieved Rapid, Sustained Outcomes in DME1

The power with EYLEA delivered rapid and sustained outcomes in the largest phase 3 anti-VEGF clinical trials completed to date in DME (N=862), with improved visual acuity at 52 and 100 weeks.1

DME—Significant vision gains at 52 and 100 weeks1

VISTA and VIVID Efficacy Results at 52 Weeks (primary endpoint) and 100 Weeks: Mean Change in BCVA,* as Measured by ETDRS Letters, vs Baseline1,‡
Graph comparing EYLEA 2mg every 8 weeks, and EYLEA 2mg every 4 weeks in DME patients showing VISTA and VIVID ETDRS letters gained over initial and sustained response. Graph comparing EYLEA 2mg every 8 weeks, and EYLEA 2mg every 4 weeks in DME patients showing VISTA and VIVID ETDRS letters gained over initial and sustained response.

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 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. Protocol-specified visits occurred every 28 (±7) days.

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.
  • Last observation carried forward; full analysis set.
  • IISafety analysis set.
  • Following 5 initial monthly doses.

Clinically significant improvement of ≥3 lines (≥15 letters of vision*) seen in DME at 52 and 100 weeks1

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

% Patients Who Gained ≥15 ETDRS Letters at 52 and 100 Weeks From Baseline vs Control (secondary endpoint)1,†

Chart showing % patients who gained ≥15 ETDRS Letters at 52 and 100 weeks in the VISTA and VIVID trials. Chart showing % patients who gained ≥15 ETDRS Letters at 52 and 100 weeks in the VISTA and VIVID trials.

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 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. Protocol-specified visits occurred every 28 (±7) days.

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.

Start EYLEA first–line. EYLEA demonstrated powerful results in patients with DME at 52 and 100 weeks1—the majority of whom were anti–VEGF–treatment–naïve2

  • EYLEA patients who were anti–VEGF–naïve at baseline—57% in VISTA; 91% in VIVID2

On average, visual acuity gains achieved during the initial response period were sustained through 100 weeks4

Mean Change in BCVA,* as Measured by ETDRS Letters, at 100 Weeks vs Baseline in Anti–VEGF–Naïve Patients (post hoc, exploratory subgroup analysis)4
Chart showing mean change in BCVA at 100 weeks vs baseline in anti-VEGF-naïve patients. Chart showing mean change in BCVA at 100 weeks vs baseline in anti-VEGF-naïve patients.

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.
  • Following 5 initial monthly doses.

Start with EYLEA—Regardless of Baseline Visual Acuity Studied4,*

Whether patients presented with better or worse baseline vision, EYLEA demonstrated powerful results in patients with DME at 100 weeks.4 Results are presented by prespecified subgroups of baseline visual acuity.4

Mean Change in BCVA,* as Measured by ETDRS Letters, vs Baseline at 100 Weeks (prespecified subgroup analysis)4

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 VIVID4
  • *Best–corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Following 3 initial monthly doses.
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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. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-2254.
  3. Brown DM, Schmidt-Erfurth U, Do DV, et al. Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology. 2015;122(10):2044-2052
  4. Data on file. Regeneron Pharmaceuticals, Inc.