Demonstrated Anatomic Outcomes in Wet AMD1-4

Sustained absence of retinal fluid was seen in the majority of EYLEA patients at 52 weeks in the Wet AMD pivotal clinical 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.

EYLEA effectiveness at drying the retina in Wet AMD1,2

Cumulative Incidence of Sustained Absence of Retinal Fluid (VIEW 1 and VIEW 2 integrated post hoc analysis)1,*
Sustained
absence defined
as absent retinal fluid
on ≥2 consecutive
visits
Week 52
≈85%

EYLEA 2 mg
every 4 weeks

≈74%

EYLEA 2 mg
every 8 weeks†

≈74%

ranibizumab
every 4 weeks

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

Anatomic measures did not influence treatment decisions in year 1 but were considered in year 25

VIEW 1 and VIEW 2 study designs: Two multicenter, double-masked clinical studies in which patients with Neovascular (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 Wet AMD patients who maintained vision, defined as losing <15 letters of visual acuity at week 52, compared to baseline.

Between week 52 and week 96, all patients received the same study drug and dosage strength as in the first 52 weeks but continued on a regimen where dosing could be extended up to 12 weeks (3 months), based on monthly investigator assessments of prespecified visual and anatomic outcomes. There was no active control comparison group that received a fixed dosing regimen in year 2. Patients were retreated if ­1 of the following criteria were met: (1) Loss of ­5 letters of visual acuity from best previous score in conjunction with recurrent fluid on time domain–optical coherence tomography (TD-OCT); (2) new or persistent fluid (any new or unchanged cystic retinal edema and/or subretinal fluid) on TD-OCT; (3) new or persistent leakage on fluorescein angiography; (4) new macular hemorrhage; (5) new-onset classic neovascularization; (6) increase in central subfield thickness (CST) of ­100 μm (cystic retinal edema and/or subretinal fluid meeting a specific quantitative thickening threshold), as measured by TD-OCT, compared with lowest previous value; (7) time lapse of ­12 weeks since previous injection.3

Efficacy endpoints evaluated after week 52 were exploratory and included the proportion of patients maintaining visual acuity, the mean change in BCVA from baseline, and the proportion of patients gaining 15 letters or more. The results of these exploratory endpoints require cautious interpretation and could represent chance findings, as a multiplicity adjustment has not been applied.

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

In a post hoc analysis, the majority of Wet AMD 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 analyses of these post hoc endpoints were not multiplicity protected and are descriptive only.

Anatomic measures did not influence treatment decisions in year 1 but were considered in year 25

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

  • *Following 3 initial monthly doses.
Proportion of Wet AMD 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 analyses of these post hoc endpoints were not multiplicity protected and are descriptive only.

Anatomic measures did not influence treatment decisions in year 1 but were considered in year 25

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

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

Prespecified Analyses of Central Retinal Thickness in Wet AMD

EYLEA decreased mean central retinal thickness by ≈130 μm to 150 μm regardless of dosing schedule across VIEW 1 and VIEW 2 clinical trials.3,4

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

Anatomic measures did not influence treatment decisions in year 1 but were considered in year 25

  • Primary efficacy endpoint in the VIEW clinical trials: Proportion of Wet AMD 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.
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 analyses of these post hoc endpoints were not multiplicity protected and are descriptive only.

Anatomic measures did not influence treatment decisions in year 1 but were considered in year 25

  • Primary efficacy endpoint in the VIEW clinical trials: Proportion of Wet AMD 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 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.
  5. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. August 2019.