EYLEA Significantly Reduced CRT at Year 1

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

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,*

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

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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See More Important Safety Information and Indications
  • CONTRAINDICATIONS: EYLEA 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. 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