Start EYLEA First-Line. In Prespecified Analyses, EYLEA Significantly Reduced Central Retinal Thickness in Patients With DME at 52 and 100 Weeks1

Anatomic outcomes at 52 and 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. 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,†
Graph showing mean change in central retinal thickness at 52 and 100 weeks in the VIVID and VISTA trials. Graph showing mean change in central retinal thickness at 52 and 100 weeks in the VIVID and VISTA trials.

Anatomic measures were not used to influence treatment decisions2

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.

  • *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 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,†
Chart showing % patients achieving a ≥2–step improvement in the VISTA and VIVID trials. Chart showing % patients achieving a ≥2–step improvement in the VISTA and VIVID trials.

  • *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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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. 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.
  2. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. August 2019.