EYLEA Effectiveness at Drying the Retina

≈80% of EYLEA patients had a sustained absence of fluid in Year 1

Integrated VIEW 1 and VIEW 2
(post hoc analysis)
Cumulative incidence of sustained absence of retinal fluid at Year 11,2,*

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 2.3

VIEW 1 and VIEW 2 Study
Designs

Two multicenter, double-masked clinical 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 Q8 following 3 initial monthly doses; 2) EYLEA 2 mg Q4; 3) EYLEA 0.5 mg Q4; or 4) ranibizumab 0.5 mg Q4. Protocol-specified visits occurred every 28 (±3) days.3

In both studies, the primary efficacy endpoint was the proportion of patients with Wet AMD who maintained vision, defined as losing <15 letters of visual acuity at Week 52, compared with baseline.3

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 Q12, 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 re-treated if ≥1 of the following
criteria were met: 1) loss of ≥5 letters of visual acuity from best previous score with recurrent fluid on 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 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.4

BCVA, best-corrected visual acuity; CST, central subfield thickness; Q4, every 4 weeks; Q8, every 8 weeks; Q12, every 12 weeks; TD-OCT, time domain–optical coherence tomography.

The Majority of Patients Treated With EYLEA Had a Dry Retina at Year 1

Patients with a dry retina at Year 1 (post hoc analysis)2,5

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 2.3

OCT, optical coherence tomography; Q4, every 4 weeks; Q8, every 8 weeks.

61% to 62% of Patients Had a Dry Retina With Q12 Dosing at Year 2

Integrated VIEW 1 and VIEW 2 (post hoc subgroup analysis)
Patients with a dry retina at Year 2 who had received only Q12 dosing after Year 16,*

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 2.3

OCT, optical coherence tomography; Q4, every 4 weeks; Q8, every 8 weeks; Q12, every 12 weeks.

Sustained Central Retinal Thickness Reduction Data

EYLEA decreased mean central retinal thickness by ≈130 μm to 150 μm regardless of dosing schedule across VIEW 1 and VIEW 2.4

Integrated VIEW 1 and VIEW 2 (prespecified exploratory analysis)
Mean change in CRT through Year 2 from baseline2,4,*

EYLEA Q4 (Year 1): the mean change in CRT was -137.9, and EYLEA ≤Q12 (Year 2) (n=522): the mean change in CRT was -127.5. EYLEA Q8 (Year 1): the mean change in CRT was -139.0, and EYLEA ≤Q12 (Year 2) (n=505): the mean change in CRT was -133.4. Ranibizumab Q4 (Year 1): the mean change in CRT was -127.8, and ranibizumab ≤Q12 (Year 2) (n=508): the mean change in CRT was -117.8. EYLEA Q4 (Year 1): the mean change in CRT was -137.9, and EYLEA ≤Q12 (Year 2) (n=522): the mean change in CRT was -127.5. EYLEA Q8 (Year 1): the mean change in CRT was -139.0, and EYLEA ≤Q12 (Year 2) (n=505): the mean change in CRT was -133.4. Ranibizumab Q4 (Year 1): the mean change in CRT was -127.8, and ranibizumab ≤Q12 (Year 2) (n=508): the mean change in CRT was -117.8.

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

Anatomic measures did not influence treatment decisions in Year 1 but were considered in Year 2.3

CRT, central retinal thickness; OCT, optical coherence tomography; Q4, every 4 weeks; Q8, every 8 weeks; Q12, every 12 weeks.

EYLEA Q12—Mean Reductions in CRT With Less Frequent Dosing in Year 2

Integrated VIEW 1 and VIEW 2 (post hoc subgroup analysis)
Mean reduction in CRT through Year 2 from baseline in eyes treated only with Q12 dosing after Year 16,*

EYLEA Q4 (Year 1), -148.5 mean change in CRT and EYLEA Q12 (Year 2) (n=284), -139.8 mean change in CRT; EYLEA Q8 (Year 1), -153.1 mean change in CRT, and EYLEA Q12 (n=245), -153.3 mean change in CRT; ranibizumab Q4 (Year 1), -141.5 mean change in CRT and ranibizumab Q12 (Year 2) (n=218), -130.6 mean change in CRT. EYLEA Q4 (Year 1), -148.5 mean change in CRT and EYLEA Q12 (Year 2) (n=284), -139.8 mean change in CRT; EYLEA Q8 (Year 1), -153.1 mean change in CRT, and EYLEA Q12 (n=245), -153.3 mean change in CRT; ranibizumab Q4 (Year 1), -141.5 mean change in CRT and ranibizumab Q12 (Year 2) (n=218), -130.6 mean change in CRT.

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 2.3

CRT, central retinal thickness; Q4, every 4 weeks; Q8, every 8 weeks; Q12, every 12 weeks.

Dosing flexibility with
EYLEA in Wet AMD3

Proven vision outcomes with
reduced injection frequency3,6

Support for the reimbursement process.
Reimbursement Support

Get information about navigating the reimbursement process. Find enrollment forms, learn about PA assistance, and more.

Product support for EYLEA® (aflibercept) Injection.
Product Support

Find complete product support—
guiding you through
orders, returns, and more.

EYLEA news, events, and more.
Resources

Get the information you
and your patients need
about EYLEA.

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. doi:10.1016/j.ophtha.2016.05.016
  2. Data on file. Regeneron Pharmaceuticals, Inc.
  3. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. March 2021.
  4. Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, et al. lntravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014;121(1):193-201. doi:10.1016/j.ophtha.2013.08.011
  5. Heier JS, Brown DM, Chong V, et al; for the VIEW 1 and VIEW 2 Study Groups. lntravitreal aflibercept (VEGF Trap-Eye) in wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537-2548. doi:10.1016/j.ophtha.2012.09.006
  6. 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. doi:10.1016/j.ajo.2019.01.005