EYLEA Significantly Reduced CRT at Year 1

Mean change in CRT through Years 1, 2, and 3 from baseline1-3,*

EYLEA® mean change in central retinal thickness (CRT), Chart EYLEA® mean change in central retinal thickness (CRT), Chart

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 decisions.4

VISTA and VIVID Study Designs

Two randomized, multicenter, double-masked, controlled clinical 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 Q8 following 5 initial monthly doses; 2) EYLEA 2 mg Q4; or 3) macular laser photocoagulation (control) at baseline and then as needed. Protocol-specified visits occurred every 28 (±7) days.4

In both clinical studies, the primary efficacy endpoint was the mean change from baseline in BCVA at Week 52, as measured by ETDRS letter score.4

BCVA, best-corrected visual acuity; CRT, central retinal thickness; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks; Q8, every 8 weeks.

EYLEA Helped Reduce Underlying DR Severity in Patients With DME

Patients achieving a ≥2-step improvement in ETDRS-DRSS score vs control at Year 2 (100 weeks) from baseline1,4,*

Vista and Vivid secondary endpoint ETDRS-DRSS score improvement, Chart Vista and Vivid secondary endpoint ETDRS-DRSS score improvement, Chart

ETDRS-DRSS is an established grading scale for measuring the severity of DR.

BCVA, best-corrected visual acuity; ETDRS-DRSS, Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale; Q4, every 4 weeks; Q8, every 8 weeks.

Visual Acuity Gains in Patients With a Sustained DRSS Improvement

Mean change in BCVA (ETDRS letters) following EYLEA Q4 or Q8 in patients with a sustained Diabetic Retinopathy Severity Scale (DRSS)
improvement in Year 1 or 2 (post hoc analysis)3

DRSS subgroups sustained change, Chart DRSS subgroups sustained change, Chart

The analyses of these post hoc endpoints were not multiplicity protected and are descriptive only.

The association between BCVA gain and a sustained ≥2-step DRSS improvement appeared independent of CRT reductions.3

BCVA, best-corrected visual acuity; CRT, central retinal thickness; DRSS, Diabetic Retinopathy Severity Scale; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks;
Q8, every 8 weeks.

Dosing flexibility with
EYLEA in DME4

EYLEA vision data in DME4

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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. doi:10.1016/j.ophtha.2015.06.017
  2. Heier JS, Korobelnik JF, Brown DM, et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology. 2016;123(11):2376-2385. doi:10.1016/j.ophtha.2016.07.032
  3. Data on file. Regeneron Pharmaceuticals, Inc.
  4. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. March 2021