nAMD

EYLEA® 8mg (114.3 mg/ml) is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME).

For those who want flexibility to optimize patient’s treatment intervals to Q16 and beyond

Save sight whilst minimizing treatment burden
Save sight whilst minimizing treatment burden
Flexibility to extend treatment intervals as far as Q20
Flexibility to extend treatment intervals as far as Q20
Suppress VEGF with a safety profile comparable to EYLEA 2mg
Suppress VEGF with a safety profile comparable to EYLEA 2mg

With only 3 loading doses and as few as 8 injections over 2 years
‡§

*Following 3 monthly loading doses, intervals can be extended to Q16, dependent on visual and/or anatomic outcomes, and subsequently to Q20 (e.g. with a T&E regimen) if visual and/or anatomic outcomes are stable. Consult the SmPC for full posology.  
Extend treatment intervals across your nAMD clinic, as far as Q20, for your eligible nAMD patients.,  
Patients could receive as few as 8 injections per dosing schedule within the trial protocol.  
§Loading doses refer to the initial monthly dosing phase.


PULSAR

Optimize vision whilst minimizing burden

Primary endpoint: mean change in BCVA from baseline to Week 48

With EYLEA® 8mg, patients achieved lasting BCVA gains from baseline with as few as 5 injections in Year 1 (Includes 3 initial monthly doses.)

  • EYLEA® 8mg was non-inferior vs. EYLEA® 2mg

Week 48

Flexibility to extend treatment intervals for eligible nAMD patients

In PULSAR, ~8 out of 10 patients maintained 16-week treatment intervals from baseline through Week 48
*

Flexibility to extend treatment intervals for eligible nAMD patients

*Patients completing Week 48: 2Q8 n=309; 8Q12 n=316; 8Q16 n=312.

Week 96

Extend treatment intervals for eligible patients across your nAMD clinic

In PULSAR, ~8 out of 10 patients achieved a last assigned dosing interval of ≥Q16 at Week 96
*

In PULSAR, ~8 out of 10 patients achieved a last assigned dosing interval of ≥Q16 at Week 96

*Patients completing Week 96: 8Q12 n=291; 8Q16 n=292.

Extend treatment intervals beyond expectations 

The first and only anti-VEGF for nAMD that allows for extension to treatment intervals of Q20 after reaching Q16
*

The first and only anti-VEGF for nAMD that allows for extension to treatment intervals of Q20 after reaching Q16

*Following 3 monthly loading doses, intervals can be extended to Q16, dependent on visual and/or anatomic outcomes, and subsequently to Q20 (e.g. with a T&E regimen) if visual and/or anatomic outcomes are stable. Consult the SmPC for full posology. 
Patients completing Week 96: 8Q12 n=291; 8Q16 n=292.

    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. CST, central subfield thickness. DME, diabetic macular edema. DRM, dose regimen 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 model for repeated measurements.
    MoA, mechanism of action. nAMD, neovascular (wet) agerelated macular degeneration. Q8, every 8 weeks. Q16, every 16 weeks. Q20, every 20 weeks. SD, standard deviation. SmPC, Summary of Product Characteristics. SRF, subretinal fluid. T&E, treat and extend. VEGF, vascular endothelial growth factor.

PP-EYL_8mg-IL-0018-1


    • 1
      EYLEA® 8mg SmPC as approved by the Israeli MoH.
    • 2
      Lanzetta P,
      et al
      . Intravitreal aflibercept 8mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial. The LANCET. Vol 403 March 23, 2024;1141-1152.
    • 3
      Lanzetta P,
      et al
      . Intravitreal aflibercept 8mg 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.
    • 4
      Brown DM. Aflibercept 8mg in patients with nAMD: 48-week results from the phase 3 PULSAR trial. Angiogenesis, exudation, and degeneration 2023. 10–11 February 2023. Virtual. Oral presentation.
    • 5
      ClinicalTrials.gov. NCT04423718. Available at: https://classic.clinicaltrials.gov/ct2/show/NCT04423718. Accessed: January 2024.