Start EYLEA First-Line. In Prespecified Analyses, EYLEA Significantly Reduced Central Retinal Thickness in Patients With DME at 52 Weeks
Anatomic outcomes at 52 and 100 weeks1
- Primary efficacy endpoint in the VISTA and VIVID clinical trials: Mean change in BCVA, as measured by ETDRS letters, at 52 weeks vs baseline. See primary endpoint results.
Mean Change in Central Retinal Thickness, as Measured by OCT,* at 52 Weeks (secondary endpoint) and 100 Weeks (exploratory endpoint) From Baseline1,†

The results of these exploratory endpoints require cautious interpretation and could represent chance findings, as a multiplicity adjustment has not been applied.
Anatomic measures were not used to influence treatment decisions2
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.
- Optical coherence tomography.
- †Last observation carried forward; full analysis set.
- §Following 5 initial monthly doses.
Power to Reduce Disease Severity2
DR in patients with DME—Significant improvement in DR severity at 100 weeks2
- Primary efficacy endpoint in the VISTA and VIVID clinical trials: Mean change in BCVA, as measured by ETDRS letters, at 52 weeks vs baseline. See primary endpoint results.
VISTA and VIVID Efficacy Results at 100 Weeks (secondary endpoint): % Patients Achieving a ≥2–Step Improvement in the ETDRS–DRSS* vs Control2,†

- 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.
- §Following 5 initial monthly doses.

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