SPACEYour Medical Portal

We're for Sustained Disease Control of nAMD

nAMD

EYLEA 8mg is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (AMD). 

PULSAR (nAMD): a robust head-to-head trial of EYLEA 8mg vs. EYLEA 2mg

Lasting vision gains

Lasting vision gains maintained with
extended intervals

Unprecedented extensions
  • ~8/10 nAMD patients randomised to the q16
arm had a last assigned treatment interval of
≥q16 through Week 96
  • ½ of nAMD patients had a last assigned
treatment interval of q20 or more
Rapid and resilient fluid control

Superior fluid control at Week 16 vs EYLEA 2mg: p=0.0002. Fluid control maintained through Week 96

With only 3 loading doses in nAMD, as few as 8 injections over 2 years and a safety profile consistent with EYLEA 2mg

We’re for those who want to maximise vision gains while minimising burden

Lasting BCVA gains from baseline were maintained from Week 48 to Week 96, with as few as 8 injections over 2 years

  • In Year 2, interval extensions were allowed for patients on 8q12 or 8q16

 

Least squares (LS) mean change in BCVA from baseline to Week 96

Vision Gaines nAMD
Vision Gaines nAMD
Lasting vision gains in nAMD with only 3 loading doses, as few as
8 injections over 2 years and a safety profile consistent with
EYLEA 2mg

We’re for those who want to confidently extend intervals for more patients

An unprecedented ~8 out of 10 patients randomised to the q16 arm achieved a last assigned dosing interval of ≥q16 at Week 96

~1 in 2 nAMD patients achieved intervals of ≥q20 while maintaining vision gains, within
2 years in PULSAR

EYLEA 8mg randomised to q12 arm

(n=291)

EYLEA 8mg randomised to q16 arm

(n=292)

Adapted from Lanzetta P. 2023.

Mean number of injections through Week 96

2q8: 12.8; 8q12; 9.7; 8q16: 8.2

Unprecedented extensions with only 3 loading doses in nAMD, as few as 8 injections over 2 years and lasting vision gains

We’re for those who want to take control and keep it

Rapid and resilient fluid control through Sustained Disease Control with EYLEA 8mg

  • In Year 2, interval extensions were allowed for patients on 8q12 or 8q16

Least squares (LS) mean change in CST from baseline at Week 48 (secondary endpoint) and Week 96

Patients nAMD

  • Significantly superior fluid control at Week 16 vs. EYLEA 2mg; fluid control is maintained through Week 482

    Proportion of patients without retinal fluid in central subfield

    graph

Faster time to fluid-free central subfield with EYLEA 8mg

Median time to a dry central subfield was 4 weeks with EYLEA 8mg vs. 8 weeks with EYLEA 2mg

Incidence nAMD
Rapid and resilient fluid control in nAMD with only 3 loading doses, as few as 8 injections in Year 1 and lasting vision gains
Sustained Disease Control with EYLEA 8mg can reduce treatment burden for your patients and may help simplify your clinical practice
Explore
Safety
Explore the EYLEA 8mg safety data in nAMD and DME patients
Dosing
Discover the posology of EYLEA 8mg
How to inject EYLEA 8mg
Learn the key steps in injecting EYLEA 8mg

  • 2q8: 2mg every 8 weeks. 

    8q12: 8mg every 12 weeks. 

    8q16: 8mg every 16 weeks. 

    BCVA: best-corrected visual acuity. 

    CI: confidence interval. 

    CRT: central retinal thickness. 

    DME: diabetic macular oedema. 

    DRM: dose reduction modification. 

    ETDRS: Early Treatment of Diabetic Retinopathy Study. 

    FAS: full analysis set. 

    ICE: intercurrent event. 

    IRF: intraretinal fluid. 

    LOCF: last observation carried forward. 

    LS: least squares. 

    MMRM: mixed models for repeated measures. 

    nAMD: neovascular (wet) age-related macular degeneration. 

    q8: every 8 weeks. 

    q12: every 12 weeks. 

    q16: every 16 weeks. 

    SRF: subretinal fluid.

Next Page
DME
    • 1
      EYLEA® 8mg (aflibercept 114.3 mg/mL, solution for injection) Summary of Product Characteristics. Berlin, Germany: Bayer Pharma AG.
    • 2
      Korobelnik J-F. Aflibercept 8 mg in patients with neovascular age-related macular degeneration: Phase 3 PULSAR trial 96-week results. AAO. 3–6 November 2023. San Francisco, USA. Oral presentation.
    • 3
      Korobelnik J-F. Intravitreal aflibercept 8 mg injection in patients with neovascular age-related macular degeneration: 48-Week results from the Phase 3 PULSAR trial. Retina Society 55th Annual Scientific Meeting. 2–5 November 2022. Pasadena, USA. Oral presentation.
    • 4
      Lanzetta P. Intravitreal aflibercept 8 mg injection in patients with neovascular age-related macular degeneration: 60-Week and 96-Week results from the Phase 3 PULSAR trial. EURETINA. 5–8 October 2023. Amsterdam, The Netherlands. Oral presentation.
    • 5
      Balaskas K, et al. Ophthalmol Ther 2021;10:231–243.
    • 6
      Chong Teo K-Y, et al. Retina 2022;42:95–106.
    • 7
      Bayer. Data on file. Clinical study report (BAY 86-5321/20968). December 2022.
    • 8
      Kaiser PK, et al. Retina 2021;41:1579–1586.
    • 9
      Cozzi M, et al. Graefes Arch Clin Exp Ophthalmol 2022;260:781–789.
    • 10
      Khachigian LM, et al. J Transl Med 2023;21:133.
    • 11
      Lanzetta P, et al. Graefes Arch Clin Exp Ophthalmol 2017;255:1259–1273.
    • 12
      Monés J, et al Ophthalmologica 2020;243:1–8.
    • a
      EYLEA 2mg was dosed at fixed q8 intervals after 3 (nAMD) or 5 (DME) initial monthly injections.²
    • b
      Primary endpoint at Week 48: mean change in BCVA (non-inferiority).³
    • c
      Patients could receive as few as 8 injections per dosing schedule within the trial protocol.
    • d
      Loading doses refers to the initial monthly dosing phase.
    • e
      Includes 3 initial monthly doses.
    • f
      PULSAR: observed values (censoring data post ICE); FAS: 2q8 n=336; 8q12 n=335; 8q16 n=338 (at baseline).²
    • g
      One-sided test for non-inferiority at 4-letter margin (based on adjusted means derived using an MMRM). LS mean change from baseline at Week 96 was +6.1 letters for 8q12, +5.9 letters for 8q16 and +7.0 letters for 2q8. Differences in LS means vs 2q8 were -1.0 (95% CI:-2.9–0.9; p=0.0009) for 8q12 and -1.1 (95% CI: -3.0–0.7; p=0.0011) for 8q16.²
    • h
      Patients completing Week 96: 8q12 n=291; 8q16 n=292.
    • i
      In PULSAR, 41% and 53% of patients randomised to the 8q12 and 8q16 arms, respectively, achieved intervals of ≥q20 (based on n=291 and n=292 patients completing Week 96 in the 8q12 and 8q16 arms, respectively).²
    • j
      EYLEA 8mg is only licensed up to treatment intervals of q20.¹
    • k
      Data are mean (SD).
    • l
      ’Without retinal fluid’ defined as absence of IRF and SRF in central subfield. LOCF (censoring data post-ICE); FAS: 2q8 n=336; 8q12 n=335; 8q16 n=338.³
    • m
      One-sided superiority p value: p=0.0002. All 8mg vs. 2q8.³
    • n
      Patients completing Week 48: 2q8 n=309; 8q12 n=316; 8q16 n=312.³
    • o
      ‘Time to fluid-free retina’ is defined as the time of first injection until the time where a patient did not have any IRF or SRF in the central subfield for the first time (regardless of whether any retinal fluid was found again after that). FAS: 2q8 n=336; 8q12 n=335; 8q16 n=338.³
    • p
      Faster time to fluid-free central subfield vs. EYLEA 2q8.³
    • q
      PULSAR: treatment-naïve patients.³
    • r
      Intervals could be shortened if DRM criteria was met.²
    • s
      Intervals could be extended if DRM criteria was met.²
    • t
      If criteria were met at Week 16 or 20, patients on 8q12 and 8q16 were shortened to q8. If criteria were met at Week 24, patients on 8q16 were shortened to q12. At subsequent dosing visits, patients on 8q12 or 8q16 had treatment intervals shortened by 4 weeks.²
    • u
      All assessments were compared with Week 12.²