EYLEA Achieved Rapid and Sustained Outcomes in DME

Demonstrated efficacy outcomes in VISTA and VIVID, phase 3 anti-VEGF trials in Diabetic Macular Edema (N=862).1

Mean change in BCVA (ETDRS letters) at Year 1 from baseline1-4,*

EYLEA® mean change in BCVA year 1, Chart EYLEA® mean change in BCVA year 1, Chart

P<0.01 vs control at Year 1.

Mean BCVA (ETDRS letters) through
Years 1, 2, and 3 from baseline
(prespecified measurements)1-5,*

Vista and Vivid study mean change in BCVA, Chart Vista and Vivid study mean change in BCVA, Chart

Mean BCVA (ETDRS letters) was measured from baseline to Year 1 as part of the primary analysis and to Years 2 and 3 as part of the prespecified
exploratory analyses and is descriptive only.

VISTA and VIVID Study Design

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.1

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.1

anti-VEGF, anti–vascular endothelial growth factor; BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks; Q8, every 8 weeks.

EYLEA Improved Vision From 20/63 to 20/40

Mean change in visual acuity at Year 3 (prespecified exploratory endpoint)2,5

EYLEA® mean change in visual acuity, Chart EYLEA® mean change in visual acuity, Chart

The results of these exploratory endpoints require cautious interpretation and could represent chance findings, as a multiplicity adjustment
has not been applied.

  • Patients gained a mean of 10 letters after the initial dosing phase (Week 20) and largely maintained gains through Year 32,5

≥20/40 vision is often required to retain driving privileges.*

BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study.

Impact of Treatment Delay on Visual Acuity Outcomes

Integrated VISTA and VIVID Results
Mean BCVA (ETDRS letters) through Year 2 from baseline in patients who received EYLEA4,6

Impact of treatment delay on visual acuity outcomes, Chart Impact of treatment delay on visual acuity outcomes, Chart

Mean BCVA (ETDRS letters) in patients who received laser and were then rescued with EYLEA starting from Month 6 (post hoc analysis
of a subgroup)4,6,*

Mean BCVA in patients who received laser and were then rescued with  EYLEA®, Chart Mean BCVA in patients who received laser and were then rescued with  EYLEA®, Chart

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

Suboptimal visual outcomes after delayed anti-VEGF treatment may be potentially related to the damaging permeability effects from long-term
VEGF overexpression that results in persistent retinal edema.6

anti-VEGF, anti–vascular endothelial growth factor; BCVA, best-corrected visual acuity; BL, baseline; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks; Q8, every 8 weeks.

Clinically Significant Improvement of ≥3 Lines of Vision at Year 1

Proportion of patients who gained ≥15 ETDRS letters at Years 1, 2, and 3 from baseline vs control1-3,5,*

EYLEA® secondary endpoint and prespecified exploratory endpoints vision gained, Chart EYLEA® secondary endpoint and prespecified exploratory endpoints vision gained, Chart

The results of these exploratory endpoints require cautious interpretation and could represent chance findings, as a multiplicity
adjustment has not been applied.

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

First-line EYLEA—Vision Gains in Anti-VEGF–Naïve Patients

The majority of EYLEA patients in VISTA (57%) and VIVID (91%) had no prior anti-VEGF treatment.1,2

On average, initial mean vision gains of ≈10 letters were sustained at Year 2 in anti-VEGF–naïve patients

Mean change in BCVA (ETDRS letters) at Year 2 from baseline in anti-VEGF–naïve patients (post hoc subgroup analysis)2,4,7

EYLEA® vision gains in Anti-VEGF–Naïve Patients, Chart EYLEA® vision gains in Anti-VEGF–Naïve Patients, Chart

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.2,4

anti-VEGF, anti–vascular endothelial growth factor; BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4, every 4 weeks; Q8, every 8 weeks.

CRT data with EYLEA2,3,5

Dosing flexibility with
EYLEA in DME1

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References
  1. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. March 2021
  2. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-2254. doi:10.1016/j.ophtha.2014.05.006
  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. doi:10.1016/j.ophtha.2015.06.017
  4. Data on file. Regeneron Pharmaceuticals, Inc.
  5. 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
  6. Wykoff CC, Marcus DM, Midena E, et al. Intravitreal aflibercept injection in eyes with substantial vision loss after laser photocoagulation for diabetic macular edema: subanalysis of the VISTA and VIVID randomized clinical trials. JAMA Ophthalmol. 2017;135(2):107-114. doi:10.1001/jamaophthalmol.2016.4912
  7. Do V, Nguyen QD, Vitti R, et al. Intravitreal aflibercept injection in diabetic macular edema patients with and without prior anti-vascular endothelial growth factor treatment: outcomes from the phase 3 program. Ophthalmology. 2016;123(4):850-857. doi:10.1016/j.ophtha.2015.11.008