Bayer Ag · XETR:BAYN

Bayer — 23rd European Society of Retina Specialists (EURETINA) Congress 2023

10 slides from Bayer's conference presentation, October 2023

  1. Slide 1: Tolerability and Safety of Intravitreal Aflibercept 8 mg in the Phase 3 PULSAR Trial

    Tolerability and Safety of Intravitreal Aflibercept 8 mg in the Phase 3 PULSAR Trial of Patients with Neovascular Age-Related Macular Degeneration Richard P. Gale,1 Jean-François Korobelnik,2,3 Ursula Maria Schmidt-Ott,4 Andrea Schulze,5 Xin Zhang,5 Sergio Leal,4 on behalf of the PULSAR study invest

  2. Slide 2: Disclosures

    Disclosures nAMD • RPG: Receives consultant fees for AbbVie, Alimera, Bayer, Biogen, Boehringer-Ingelheim, Novartis, Roche, and Santen; and receives research grants for Bayer, Novartis, and Roche o JFK: Receives consultant fees for AbbVie, Apellis, Bayer, Janssen, Nano Retina, Roche, Théa Pharmaceut

  3. Slide 3: PULSAR Study Design

    PULSAR Study Design Multicenter, randomized, double-masked study in patients with treatment-naive nAMD Randomized at baseline 1 (2q8) : 1 (8q12) : 1 (8q16) 2q8 Aflibercept 2 mg every 8 weeks after 3 initial monthly injections n=336 Primary endpoint at Week 48: Mean change in BCVA (non-inferiority) K

  4. Slide 4: PULSAR: Dosing Schedule and Regimen Modification in Year 1

    PULSAR: Dosing Schedule and Regimen Modification in Year 1 nAMD

  5. Slide 5: Patient Disposition at Week 48

    Patient Disposition at Week 48 nAMD

  6. Slide 6: PULSAR: 48-Week BCVA Results Primary Endpoint Met in Both 8 mg Groups

    PULSAR: 48-Week BCVA Results Primary Endpoint Met in Both 8 mg Groups nAMD

  7. Slide 7: Ocular AEs in the Study Eye Through Week 48

    Ocular AEs in the Study Eye Through Week 48 nAMD

  8. Slide 8: Intraocular Pressure and Intraocular Inflammation Through Week 48

    Intraocular Pressure and Intraocular Inflammation Through Week 48 nAMD

  9. Slide 9: Non-Ocular AEs Through Week 48

    Non-Ocular AEs Through Week 48 nAMD

  10. Slide 10: Conclusions

    Conclusions nAMD • The safety profile for aflibercept 8 mg was similar to that of aflibercept 2 mg1,2 • There were no new safety signals for aflibercept 8 mg or aflibercept 2 mg and no cases of retinal vasculitis, occlusive retinitis, or endophthalmitis • Rates of APTC events and IOI were comparable

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