EYLEA Achieved Rapid, Sustained Outcomes in Wet AMD and DME1-5

The power with EYLEA delivered rapid and sustained outcomes in the largest phase 3 anti-VEGF clinical trials completed to date in Wet AMD (N=2412) with maintained visual acuity at 52 and 96 weeks and in DME (N=862) with improved visual acuity at 52 and 100 weeks.1-6


Wet AMD—Powerful visual acuity results in the largest phase 3 anti-VEGF trials completed to date1-6

Proportion of Patients Who Maintained Vision (<15 letters lost) at 52 Weeks (primary endpoint) and 96 Weeks Based on BCVA,* as Measured by ETDRS Letters1,3,‡
View 1 - 94% of patients maintained vision at 1 year. View 2 - 95% of patient maintained vision at 1 year. 95.1% confidence interval. View 1 - 94% of patients maintained vision at 1 year. View 2 - 95% of patient maintained vision at 1 year. 95.1% confidence interval.

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® (aflibercept) Injection 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 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 BCVA from baseline, and the proportion of patients gaining 15 letters or more.

EYLEA was clinically equivalent to ranibizumab.

  • *Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Last observation carried forward; full analysis set.
  • Percentage reflects combination of EYLEA 2Q4 and 2Q8 treatment groups following 3 initial monthly doses.
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,‡
Graph comparing EYLEA to ranibizumab in Wet AMD patients showing ETDRS letters gained over initial and sustained response. Plus 9.3 letters for EYLEA 2 mg every 4 weeks. Plus 8.7 letters for ranibizumab 0.5 mg every 4 weeks. Plus 8.4 letters for EYLEA 2mg every 8 weeks. Graph comparing EYLEA to ranibizumab in Wet AMD patients showing ETDRS letters gained over initial and sustained response. Plus 9.3 letters for EYLEA 2 mg every 4 weeks. Plus 8.7 letters for ranibizumab 0.5 mg every 4 weeks. Plus 8.4 letters for EYLEA 2mg every 8 weeks.
  • In the VIEW 1 and 2 studies, the 2Q4 and 2Q8 groups decreased, on average, by 1 to 2 letters at week 96 compared to week 521
  • *Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Last observation carried forward; full analysis set.
  • IISafety analysis set.
  • Following 3 initial monthly doses.
EYLEA LARGELY MAINTAINED VISION GAINS
Results at 52 and 96 weeks4,5
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 Q12 Dosing in Year 24,5,‡
Graph showing EYLEA vision gains at 96 weeks. Graph showing EYLEA vision gains at 96 weeks.
  • Q12 dosing is not as effective as the recommended Q8 dosing regimen1
  • Based on physician assessment of prespecified visual and anatomic outcomes from week 52 through 96, ≈51% of EYLEA 2 mg patients only received Q12 dosing from week 52 through 96 and achieved a mean change in BCVA from baseline to week 96 of +9.0 letters5
  • Eyes treated with only Q12 include ≈4% of patients who were dosed outside of Q124,5
  • *Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Last observation carried forward; full analysis set.
  • §Safety analysis set.
  • IIFollowing 3 initial monthly doses.

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® (aflibercept) Injection 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 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 BCVA from baseline, and the proportion of patients gaining 15 letters or more.

Results at 212 weeks7
VIEW 1 Extension: Mean Change in BCVA,* as Measured by ETDRS Letters at 212 Weeks (4 years) vs Extension Baseline (secondary endpoint)7,‡
Graph showing EYLEA vision gains over 212 weeks. Graph showing EYLEA vision gains over 212 weeks.
  • The VIEW 1 Extension included patients switched at week 96 from the ranibizumab treatment arm in VIEW 17
  • 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 2127

No new safety signals compared with the known safety profile of EYLEA in the Wet AMD population.7

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).

DME—Significant and powerful vision gains at 52 and 100 weeks1

VISTA and VIVID Efficacy Results at 52 Weeks (primary endpoint) and 100 Weeks: Mean Change in BCVA,* as Measured by ETDRS Letters, vs Baseline1,‡
Graph comparing EYLEA to ranibizumab in DME patients showing VISTA and VIVID ETDRS letters gained over initial and sustained response. Graph comparing EYLEA to ranibizumab in DME patients showing VISTA and VIVID ETDRS letters gained over initial and sustained response.

VISTA and VIVID study designs: Two randomized, multicenter, double-masked, controlled 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® (aflibercept) Injection 2 mg administered every 8 weeks following 5 initial monthly doses; 2) EYLEA 2 mg administered every 4 weeks; or 3) macular laser photocoagulation (control), at baseline and then as needed. Protocol-specified visits occurred every 28 (±7) days.

In both studies, the primary efficacy endpoint was the mean change from baseline in best-corrected visual acuity at week 52, as measured by Early Treatment Diabetic Retinopathy Study letter score.

  • *Best-corrected visual acuity.
  • Early Treatment Diabetic Retinopathy Study.
  • Last observation carried forward; full analysis set.
  • IISafety analysis set.
  • Following 5 initial monthly doses.
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Important Safety Information and Indications
  • 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 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) in patients with DME.

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 2018.
  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 R. Extended injection interval (≥q12 wks) maintains vision in neovascular age-related macular degeneration: year 2 VIEW subanalysis. Poster presented at: American Academy of Ophthalmology Annual Meeting; November 11-14, 2017; New Orleans, LA.
  5. Data on file. Regeneron Pharmaceuticals, Inc.
  6. Lucentis® (ranibizumab injection) full U.S. Prescribing Information. Genentech, Inc. March 2018.
  7. 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.
  8. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-2254.
  9. 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.