Powerful Visual Acuity Outcomes in the Largest Phase 3 Anti-VEGF Clinical Trials Completed to Date in Wet AMD (N=2412)1-4

EYLEA efficacy: Vision gains at week 52 were largely maintained at week 961,3

Proportion of Patients With Wet AMD Who Maintained Vision (<15 letters lost) at 52 Weeks (primary endpoint) and 96 Weeks Based on BCVA,* as Measured by ETDRS Letters1,3,‡
Year 1 Year 2
VIEW 1 94%
of EYLEA-treated patients maintained
vision at 52 weeks1,§
92%
of EYLEA-treated patients maintained
vision at 96 weeks3
VIEW 2 95%
of EYLEA-treated patients maintained
vision at 52 weeks1,§
92%
of EYLEA-treated patients maintained
vision at 96 weeks3
VIEW 1: 94% of EYLEA® (aflibercept) Injection patients maintained vision at 52 weeks and 92% at 96 weeks. VIEW 2: 95% of EYLEA-treated patients maintained vision at 52 weeks and 92% at 96 weeks. VIEW 1: 94% of EYLEA® (aflibercept) Injection patients maintained vision at 52 weeks and 92% at 96 weeks. VIEW 2: 95% of EYLEA-treated patients maintained vision at 52 weeks and 92% at 96 weeks.

EYLEA was clinically equivalent to ranibizumab. The proportion of patients who maintained visual acuity for ranibizumab 0.5 mg every 4 weeks was 94% in VIEW 1 and 95% in VIEW 2 at 52 weeks.1,3


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.4

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.

  • anti-VEGF = anti–vascular endothelial growth factor.
  • *Best–corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Last observation carried forward; full analysis set.
  • §Percentage reflects combination of EYLEA 2 mg every–4–week and 2 mg every–8–week treatment groups following 3 initial monthly doses.

Wet AMD—Rapid and Largely Sustained Visual Acuity Results2,3

VIEW 1 and 2 Integrated Efficacy Results at 52 Weeks (secondary endpoint) and 96 Weeks: Mean Change in BCVA,* as Measured by ETDRS Letters, vs Baseline2,3,‡
Mean Change in BCVA at 52 and 96 Weeks, Measured by ETDRS Letters Mean Change in BCVA at 52 and 96 Weeks, Measured by ETDRS Letters

  • *Best–corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Last observation carried forward; full analysis set.
  • §Safety analysis set.
  • IIFollowing 3 initial monthly doses.

EYLEA Achieved Rapid, Sustained Outcomes in Wet AMD4

EYLEA is an anti–VEGF treatment that offers 3 FDA–approved dosing intervals in Wet AMD, including an every–12–week dosing option after one year of effective therapy,* with sustained efficacy in Wet AMD.1

*Although not as effective as the recommended every-8-week dosing regimen, patients may also be treated with one dose every 12 weeks after one year of effective therapy. Patients should be assessed regularly.

Results at 52 and 96 weeks4

VIEW 1 and VIEW 2 Integrated Efficacy Results at 96 Weeks (post hoc subgroup analysis): Mean Change in BCVA,* as Measured by ETDRS Letters, vs Baseline in Eyes Treated Only With Every–12–Week Dosing in Year 24,‡
Chart showing mean change in visual acuity measured by ETDRS letters gained. Patients who received only every-12-week dosing (3 additional injections from week 52 to 96) +9.2=48% EYLEA® (aflibercept) Injection 2 mg every 8 weeks, +8.8=54% EYLEA® (aflibercept) Injection 2 mg every 4 weeks, and +8.5=43% ranibizumab 0.5 mg every 4 weeks. Chart showing mean change in visual acuity measured by ETDRS letters gained. Patients who received only every-12-week dosing (3 additional injections from week 52 to 96) +9.2=48% EYLEA® (aflibercept) Injection 2 mg every 8 weeks, +8.8=54% EYLEA® (aflibercept) Injection 2 mg every 4 weeks, and +8.5=43% ranibizumab 0.5 mg every 4 weeks.

Less frequent EYLEA dosing in Wet AMD largely sustained visual acuity gains in year 2 vs baseline4

In a post hoc subgroup analysis, based on physician assessment of prespecified visual and anatomic outcomes from week 52 to 964

51%
of EYLEA 2 mg patients
only received every-12-week
dosing
from week 52 to 96
And achieved a mean
change in BCVA from
baseline to week 96 of
+ 9.0
letters
  • Every-12-week dosing is not effective as the recommended every-8-week
    dosing regimen1
  • Every-12-week-only dosing group included ≈4% of patients who were dosed outside the every-12-week window4
51% of EYLEA® (aflibercept) Injection 2 mg patients only received every-12-week dosing from week 52 to 96 and achieved a mean change in BCVA from baseline to week 96 of +9.0 ETDRS letters.
  • 529 of 1038 EYLEA 2 mg patients at week 96.
  • The analyses of these post hoc endpoints were not multiplicity protected and are descriptive only.
  • Patients Receiving Only Every-12-Week Dosing in Year 24

    VIEW 1 VIEW 2
    EYLEA 2 mg every 4 weeks in year 1 50% 58%
    EYLEA 2 mg every 8 weeksII in year 1 43% 53%
    ranibizumab 0.5 mg every 4 weeks in year 1 46% 39%
  • *Best–corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Last observation carried forward; full analysis set.
  • §Safety analysis set.
  • IIFollowing 3 initial monthly doses.

EYLEA Largely Maintained Vision Gains in Wet AMD at 4 Years (212 Weeks) From the Extension Baseline6

VIEW 1 Extension: Mean Change in BCVA,* From VIEW 1 Baseline, as Measured by ETDRS Letters, Through Week 212 (4 years)6,‡
Chart showing mean change in BCVA of +7.1 over 212 weeks. Chart showing mean change in BCVA of +7.1 over 212 weeks.

  • The VIEW 1 Extension included patients switched at week 96 from the ranibizumab treatment arm in VIEW 16
  • VIEW 1 had fixed dosing through week 52, followed by modified quarterly dosing (at least every 12 weeks) through week 96. In the VIEW 1 Extension, all patients received EYLEA 2 mg on a modified quarterly dosing schedule (up to every 12 weeks), later amended to dosing at least every 8 weeks through week 2126

No new safety signals compared with the known safety profile of EYLEA in the Wet AMD population.6

VIEW 1 Extension study design: Prospective, open–label, single–arm, multicenter, long–term safety and tolerability study of patients who completed VIEW 1 through week 96 (n=323; mean age: 79). All patients received EYLEA 2 mg on a modified quarterly dosing schedule (maximum treatment interval: every 12 weeks) that was later amended to dosing at least every 8 weeks through week 212.

The primary endpoint was the safety and tolerability of EYLEA.

  • *Best–corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Last observation carried forward; full analysis set (n=323).

EYLEA First–Line Achieved Clinically Significant and Sustained Vision Gains in Wet AMD3

A proportion of EYLEA patients gained 3 or more lines (≥15 letters of vision*) across all pivotal studies of patients with Wet AMD at 52 and 96 weeks.3,†

% Patients Who Gained ≥15 ETDRS Letters at 52 Weeks (secondary endpoint) and 96 Weeks From Baseline vs Control3,†
Chart showing % of patients who gained ≥ 15 ETDRS letters at weeks 52 and 96. Chart showing % of patients who gained ≥ 15 ETDRS letters at weeks 52 and 96.

  • *Best–corrected visual acuity, as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
  • Last observation carried forward; full analysis set.
  • Following 3 initial monthly doses.

EYLEA Demonstrated Results in Wet AMD Regardless of Baseline Visual Acuity Studied5,*

EYLEA provided sustained visual acuity outcomes in patients with both better and worse baseline vision.5

% Patients Who Maintained Vision (<15 letters lost) Based on Baseline BCVA by Baseline Visual Acuity Category,* as Measured by ETDRS Letters, at 52 Weeks (prespecified subgroup analysis)5
Chart showing % patients who maintained vision (<15 letters lost) based on baseline BCVA by baseline visual acuity category. Chart showing % patients who maintained vision (<15 letters lost) based on baseline BCVA by baseline visual acuity category.

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

Treatment effects in evaluable subgroups in each study were in general consistent with the results in the overall populations

  • *Best–corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Following 3 initial monthly doses.

EYLEA Improvement in Visual Acuity in Wet AMD Patients With and Without Early Persistent Retinal Fluid7

Mean Change in BCVA,* as Measured by ETDRS Letters, in Patients With Early Persistent Retinal Fluid at 52 Weeks vs Baseline (VIEW 1 and VIEW 2 post hoc analysis)7
Chart showing mean change in visual acuity in patients with early persistent retinal fluid. Chart showing mean change in visual acuity in patients with early persistent retinal fluid.

Mean Change in BCVA,* as Measured by ETDRS Letters, in Patients Without Early Persistent Retinal Fluid at 52 Weeks vs Baseline (VIEW 1 and VIEW 2 post hoc analysis)7
Chart showing mean change in visual acuity in patients without early persistent retinal fluid. Chart showing mean change in visual acuity in patients without early persistent retinal fluid.

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

  • Early persistent fluid was defined as retinal fluid (intraretinal [cystic] or subretinal) at baseline and after 3 initial monthly anti–VEGF§ injections as seen on time–domain OCT7,II
  • ≈20% of Wet AMD patients treated with EYLEA experienced early persistent retinal fluid7
  • *Best–corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Following 3 initial monthly doses.
  • §Anti–vascular endothelial growth factor.
  • IIOptical coherence tomography.
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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. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. August 2019.
  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. 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.
  4. 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.
  5. Data on file. Regeneron Pharmaceuticals, Inc.
  6. Kaiser PK, Singer M, Tolentino M, et al. Long-term safety and visual outcome of intravitreal aflibercept in neovascular age-related macular degeneration: VIEW 1 extension study. Ophthalmol Retina. 2017;1(4):304-313.
  7. 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.