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We’re for Sustained Disease Control of DME

DME

EYLEA 8mg is indicated in adults for the treatment of visual impairment due to diabetic macular oedema (DME).

PHOTON (DME): a robust randomised trial of EYLEA 8mg
vs. EYLEA 2mg

Lasting vision gains

Lasting vision gains maintained with extended intervals

Unprecedented extensions
  • ~9/10 patients randomised to the q16 arm had
a last assigned treatment interval of ≥q16
through Week 96
  • ½ of DME patients had a last assigned
treatment interval of q20 or more
Resilient fluid control

Fluid control maintained through Week 96

With only 3 loading doses, as few as 8 injections over 2 years and a safety profile consistent with EYLEA 2mg
~35% fewer injections in Year 1 with EYLEA 8mg vs. EYLEA 2mg

We’re for those who want to maximise vision gains and minimise 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

 

LS mean change in BCVA from baseline to Week 96

Vision Gaines DME
Lasting vision gains in DME, 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 ~9 out of 10 patients randomised to the q16 arm achieved a last assigned dosing interval of ≥q16 at Week 96

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

EYLEA 8mg randomised to q12 arm

(n=256)

EYLEA 8mg randomised to q16 arm

(n=139)

Adapted from Wykoff CC. 2023.

Mean number of injections through Week 96

2q8: 13.8; 8q12: 9.5; 8q16: 7.8

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

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

Resilient fluid control through SDC with EYLEA 8mg

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

Mean change in CRT from baseline at Week 48 (secondary endpoint) and Week 96

CRT Graph
Resilient fluid control in DME, with only 3 loading doses, as few as
8 injections over 2 years 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 edema.

    DRM: dose reduction modification.

    DRSS: Diabetic Retinopathy Severity Scale.

    ETDRS: Early Treatment of Diabetic Retinopathy Study.

    FAS: full analysis set.

    ICE: intercurrent event.

    IRF: intraretinal fluid.

    LS: least squares.

    MMRM: mixed models for repeated measures.

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

    q8: every 8 weeks.

    q16: every 16 weeks.

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Mode of Action
    • 1
      EYLEA® 8mg (aflibercept 114.3 mg/mL, solution for injection) Summary of Product Characteristics. Berlin, Germany: Bayer Pharma AG.
    • 2
      Do D. Aflibercept 8 mg for diabetic macular edema: 96-week results from the Phase 2/3 PHOTON trial. AAO. 3–6 November 2023. San Francisco, USA. Oral presentation.
    • 3
      Wykoff CC. Aflibercept 8 mg for diabetic macular edema: 96-Week results from the Phase 2/3 PHOTON trial. EURETINA. 5–8 October 2023. Amsterdam, The Netherlands. Oral presentation.
    • 4
      Balaskas K, et al. Ophthalmol Ther 2021;10:231–243.
    • 5
      Chong Teo K-Y, et al. Retina 2022;42:95–106.
    • 6
      Do D. Aflibercept 8 mg for diabetic macular edema: 48-week results from the Phase 2/3 PHOTON trial. ARVO. 23–27 April 2023. Palo Alto, USA. Oral presentation.
    • 7
      Cozzi M, et al. Graefes Arch Clin Exp Ophthalmol 2022;260:781–789.
    • 8
      Khachigian LM, et al. J Transl Med 2023;21:133.
    • 9
      Lanzetta P, et al. Graefes Arch Clin Exp Ophthalmol 2017;255:1259–1273.
    • 10
      Monés J, et al Ophthalmologica 2020;243:1–8.
    • a
       EYLEA 2mg was dosed at fixed q8 intervals after 5 initial monthly injections.²
    • b
      Primary endpoint at Week 48: mean change in BCVA (non-inferiority).²
    • c
      Patients could receive as few as 8 injections per dosing schedule within the trial protocol.²
    • d
      Loading doses refers to the initial monthly dosing phase.
    • e
      Includes 3 initial monthly doses.
    • f
      PHOTON: observed values (censoring data post-ICE); FAS: 2q8 n=167; 8q12 n=328; 8q16 n=163 (at baseline).2²
    • g
      1-sided test for non-inferiority at 4-letter margin (based on adjusted means derived using MMRM analysis). LS mean change from baseline at Week 48 was +8.1 letters for 8q12, +7.2 letters for 8q16 and +8.7 letters for 2q8. Differences in LS means vs. 2q8 were -0.6 (95% CI: -2.3, 1.1; p<0.0001) for 8q12 and -1.4 (95% CI: -3.3, 0.4; p=0.0031) for 8q16.2²
    • h
      Patients completing Week 96: 8q12 n=256; 8q16 n=139.2²
    • i
      In PHOTON, 43% and 47% of patients randomised to the 8q12 and 8q16 arms, respectively, achieved intervals of ≥q20 (based on n=256 and n=139 patients completing Week 96 in the 8q12 and 8q16 arms, respectively).2²
    • j
      EYLEA 8mg is only licensed up to treatment intervals of q20.¹
    • k
      Mean number of injections through Week 96: EYLEA 2q8: 13.8; EYLEA 8q12: 9.5; 8q16: 7.8.²
    • l
      PHOTON: treatment-naïve (56%) and previously-treated (patients 44%).²
    • m
      Number of randomised (FAS) patients with DME in the 2mg q8, 8mg q12 and 8mg q16 groups: 167 (167), 329 (328) and 164 (163), respectively.²
    • n
      Intervals could be shortened if DRM criteria was met.²
    • o
      Intervals could be extended if DRM criteria was met.²
    • p
      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
    • q
      All assessments were compared with Week 12.²