Demonstrated Anatomic Outcomes in Wet AMD1-4

The majority of EYLEA patients achieved sustained absence of retinal fluid at 52 weeks in the Wet AMD pivotal trials.1

  • Primary efficacy endpoint in the VIEW trials: Proportion of patients who maintained vision (<15 letters lost) at 52 weeks vs baseline. See primary endpoint results.

Effectiveness of EYLEA at drying the retina1,2

Cumulative Incidence of Sustained Absence of Retinal Fluid (VIEW 1 and VIEW 2 integrated post hoc analysis)1,*
Chart showing cumulative incidence of sustained absence of retinal fluid in VIEW 1 and VIEW 2 at 52 weeks. Sustained absence defined as absent retinal fluid on 2 or more consecutive visits. Chart showing cumulative incidence of sustained absence of retinal fluid in VIEW 1 and VIEW 2 at 52 weeks. Sustained absence defined as absent retinal fluid on 2 or more consecutive visits.

The results of this post hoc analysis requires cautious interpretation and could represent chance findings, as multiplicity adjustment has not been applied.

VIEW 1 and VIEW 2 study designs: Two multicenter, double-masked studies in which patients with Wet AMD (N=2412; age range: 49-99 years, with a mean of 76 years) were randomized to receive 1) EYLEA 2 mg administered every 8 weeks following 3 initial monthly doses; 2) EYLEA 2 mg administered every 4 weeks; 3) EYLEA 0.5 mg administered every 4 weeks; or 4) ranibizumab 0.5 mg administered every 4 weeks. Protocol-specified visits occurred every 28 (±3) days.

In both studies, the primary efficacy endpoint was the proportion of patients who maintained vision, defined as losing <15 letters of visual acuity at week 52, compared to baseline.

Between week 52 and week 96, patients randomized to EYLEA 2 mg every 4 weeks or every 8 weeks continued on a regimen where dosing could be extended up to 12 weeks (3 months), based on regular assessments. The need for dosing was guided by investigator assessment of prespecified visual and anatomic outcomes. There was no active control comparison group that utilized a fixed dosing regimen in year 2. Efficacy endpoints evaluated after week 52 were exploratory and included the proportion of patients maintaining visual acuity, the mean change in best-corrected visual acuity from baseline, and the proportion of patients gaining 15 letters or more.

  • *Full analysis set.
  • †Following 3 initial monthly doses.

In a post hoc analysis, the majority of patients treated with EYLEA had a dry retina at Week 52.2

Proportion of Patients With a Dry Retina* at 52 Weeks (post hoc endpoint)2
Chart showing % of patients with dry retina at 52 weeks in VIEW 1 and VIEW 2. Chart showing % of patients with dry retina at 52 weeks in VIEW 1 and VIEW 2.

The results of this post hoc analysis requires cautious interpretation and could represent chance findings, as multiplicity adjustment has not been applied.

Anatomic measures did not influence treatment decisions in year 1 but were considered in year 21

  • Primary efficacy endpoint in the VIEW trials: Proportion of patients who maintained vision (<15 letters lost) at 52 weeks vs baseline. See primary endpoint results.

  • *Defined as the absence of cystic intraretinal edema and subretinal fluid on optical coherence tomography (OCT).
  • †Following 3 initial monthly doses.
Proportion of Patients Treated Only With Every–12–Week Dosing in Year 2 Who Were Without Retinal Fluid* at Week 96 (post hoc subgroup analysis) (VIEW 1 and VIEW 2 integrated efficacy results)3,†
Chart showing % of patients treated only with every-12-week dosing who were without retinal fluid at week 96. Chart showing % of patients treated only with every-12-week dosing who were without retinal fluid at week 96.

The results of this post hoc subgroup analysis requires cautious interpretation and could represent chance findings, as multiplicity adjustment has not been applied.

  • Primary efficacy endpoint in the VIEW trials: Proportion of patients who maintained vision (<15 letters lost) at 52 weeks vs baseline. See primary endpoint results.

  • *Without retinal fluid defined as absence of cystic intraretinal edema and subretinal fluid on OCT.
  • †Full analysis set; observed cases.
  • ‡Following 3 initial monthly doses.

Prespecified Analyses of Central Retinal Thickness

EYLEA decreased mean central retinal thickness by 100 μm to 150 μm regardless of dosing schedule across VIEW 1 and VIEW 2.4

Mean Change in Central Retinal Thickness, as Measured by OCT,* Over 96 Weeks (prespecified exploratory analysis) (VIEW 1 and VIEW 2 integrated efficacy results)4,†
Chart showing mean change in central retinal thickness over 96 weeks. Chart showing mean change in central retinal thickness over 96 weeks.

The results of this prespecified exploratory analysis requires cautious interpretation and could represent chance findings, as multiplicity adjustment has not been applied.

Anatomic measures did not influence treatment decisions in year 1 but were considered in year 24

  • Primary efficacy endpoint in the VIEW trials: Proportion of patients who maintained vision (<15 letters lost) at 52 weeks vs baseline. See primary endpoint results.

  • *Optical coherence tomography.
  • †Last observation carried forward; full analysis set. VIEW 1: OCTs mandatory at baseline and weeks 4,12, 24, 36, 52, and every 4 weeks thereafter through week 96; VIEW 2: OCTs mandatory at all visits.
  • ‡Following 3 initial monthly doses in year 1.
Mean Reductions in Central Retinal Thickness, as Measured by TD–OCT,* in Eyes Treated Only With Every–12–Week Dosing in Year 2 (post hoc subgroup analysis) (VIEW 1 and VIEW 2 integrated efficacy results)3, †
Chart showing mean change in central retinal thickness over 96 weeks in patients treated only with every-12-week dosing. Chart showing mean change in central retinal thickness over 96 weeks in patients treated only with every-12-week dosing.

The results of this post hoc subgroup analysis requires cautious interpretation and could represent chance findings, as multiplicity adjustment has not been applied.

  • Primary efficacy endpoint in the VIEW trials: Proportion of patients who maintained vision (<15 letters lost) at 52 weeks vs baseline. See primary endpoint results.

  • *Time domain–optical coherence tomography.
  • †Last observation carried forward; full analysis set.
  • ‡Following 3 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. Jaffe GJ, Kaiser PK, Thompson D, et al. Differential response to anti-VEGF regimens in age-related macular degeneration patients with early persistent retinal fluid. Ophthalmology. 2016;123(9):1856-1864.
  2. Heier JS, Brown DM, Chong V, et al; for the VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF Trap-Eye) in wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537-2548.
  3. Khurana RN, Rahimy E, Joseph WA, et al. Extended (every 12 weeks or longer) dosing interval with intravitreal aflibercept and ranibizumab in neovascular age-related macular degeneration: post hoc analysis of VIEW trials. Am J Ophthalmol. 2019;200:161-168.
  4. Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, et al. Intravitreal aflibercept injection for neovascular age-related macular degeneration. Ninety-six-week results of the VIEW studies. Ophthalmology. 2014;121(1):193-201.