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 Diabetic Macular Edema (N=862), with improved visual acuity at 52 and 100 weeks.1
EYLEA efficacy in DME—Significant vision gains at 52 and 100 weeks1
VISTA and VIVID Efficacy Results at 52 Weeks (primary endpoint) and 100 Weeks (prespecified exploratory endpoint): Mean Change in BCVA,* as Measured by ETDRS† Letters, vs Baseline1,‡

VISTA and VIVID study designs: Two randomized, multicenter, double-masked, controlled clinical studies in which patients with Diabetic Macular Edema (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 clinical 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.
The results of these exploratory endpoints require cautious interpretation and could represent chance findings, as a multiplicity adjustment has not been applied.
- 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 Diabetic Macular Edema at 52 and 100 weeks.1
% Patients Who Gained ≥15 ETDRS Letters at 52 Weeks (secondary endpoint) and 100 Weeks (prespecified exploratory endpoint) From Baseline vs Control1,†

The results of these exploratory endpoints require cautious interpretation and could represent chance findings, as a multiplicity adjustment has not been applied.
- 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.
EYLEA demonstrated 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
VISTA | VIVID | |
EYLEA 2mg every 8 weeks‡ | 11.3 (n=83) | 8.9 (n=120) |
EYLEA 2mg every 4 weeks | 12.0 (n=87) | 11.2 (n=128) |
Control | 2.1 (n=91) | 0.8 (n=119) |

The analyses of these post hoc endpoints were not multiplicity protected and are descriptive only.
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.
EYLEA Results Regardless of Baseline Visual Acuity Studied4,*
Whether patients presented with better or worse baseline vision, EYLEA demonstrated 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

- Similar results were seen at 100 weeks in VIVID4
The results of this prespecified subgroup analysis require cautious interpretation and could represent chance findings, as a multiplicity adjustment has not been applied.
- Best–corrected visual acuity.
- †Early Treatment Diabetic Retinopathy Study.
- ‡Following 3 initial monthly doses.

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