Bayer Ag · XETR:BAYN

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

19 slides from Bayer's conference presentation, October 2023

  1. Slide 1: Intravitreal Aflibercept 8 mg Injection: Results From the PULSAR and PHOTON Trials

    Intravitreal Aflibercept 8 mg Injection: Results From the PULSAR and PHOTON Trials Sobha Sivaprasad,1 on behalf of the PULSAR and PHOTON study investigators 1Moorfields Eye Hospital, London, UK Presented at the 23rd European Society of Retina Specialists (EURETINA) Congress, Amsterdam, The Netherlan

  2. Slide 2: Disclosures

    Disclosures • SS: Receives funding/fees from Allergan, Apellis, Bayer, Biogen, Boehringer Ingelheim, EyeBiotech, Novartis, Optos, and Roche. • The PULSAR study was sponsored by Bayer AG (Leverkusen, Germany) and co-funded by Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA). The sponsor participa

  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) Ke

  4. Slide 4: PULSAR: Dosing Schedule and Regimen Modification

    PULSAR: Dosing Schedule and Regimen Modification nAMD

  5. Slide 5: Patient Disposition and Baseline Characteristics

    Patient Disposition and Baseline Characteristics nAMD

  6. Slide 6: BCVA Outcomes

    BCVA Outcomes ulsa a BCVA Change from BL (LS Means) omrpwn rome wellJAMD 2q8 | +7.0 | +7.2 | +6.6 8qi2 | +6.1 | +64 | +56 aqié | +59 | +6.3 | +5.5 a eo a (ETDRS letters) 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 Week Absolute BCVA (Observed Values) o Week 48 Week 60 Week

  7. Slide 7: Central Subfield Thickness

    Central Subfield Thickness nAMD

  8. Slide 8: Mean Number of Injections through Week 96

    Mean Number of Injections through Week 96 nAMD

  9. Slide 9: Last Assigned Dosing Interval at Week 96

    Last Assigned Dosing Interval at Week 96a nAMD

  10. Slide 10: Safety Through Week 96

    Safety Through Week 60 nAMD aIn the study eye. bTreatment emergent. cAll events. dDefined by preferred terms ‘intraocular pressure increased’ and ‘ocular hypertension’. APTC, Anti-Platelet Trialists' Collaboration; IOI, intraocular inflammation; IOP, intraocular pressure; SAE, serious adverse event;

  11. Slide 11: PULSAR: 96-Week Results

    PULSAR: 96-Week Results nAMD

  12. Slide 12: PHOTON Study Design

    PHOTON Study Design Multi-center, randomized, double-masked study in adult patients with center-involved DME® Randomized 1 (2q8) : 2 (8q12) : 1 (8q16) Note: 2 mg arm received 5 initial monthly injections versus 8 mg arms, which received only 3 initial monthly injections 2q8 Aflibercept 2 mg every 8

  13. Slide 13: PHOTON: Dosing Schedule and Dose Regimen Modification

    PHOTON: Dosing Schedule and Dose Regimen Modification DME

  14. Slide 14: Patient Disposition and Baseline Characteristics

    Patient Disposition and Baseline Characteristics DME

  15. Slide 15: Mean Change in BCVA Through Week 48

    Mean Change in BCVA Through Week 48 DME

  16. Slide 16: Mean Number of Injections Through Week 48

    Mean Number of Injections Through Week 48 DME

  17. Slide 17: Large Majority of Patients Receiving Aflibercept 8 mg Maintained Randomized Intervals Through Week 48

    Large Majority of Patients Receiving Aflibercept 8 mg Maintained Randomized Intervals Through Week 48

  18. Slide 18: Safety Through Week 48

    Safety Through Week 48 GE @&P «& plsmg 167 328 163 491 N (SAF) Ocular safety Patients with 21 ocular AE# Patients with 21 1Ol TEAE Patients with IOP 235 mmHg pre- or post-injection Non-ocular safety APTC events® Hypertension events® Non-ocular SAEs® Deaths* + No cases of endophthalmitis, occlusive r

  19. Slide 19: PHOTON: 48-Week Results

    PHOTON: 48-Week Results + Aflibercept 8q12 and 8q16 groups had non-inferior BCVA compared to aflibercept 2q8 at Week 48 DME + The safety of aflibercept 8 mg was comparable to that of aflibercept 2 mg BCVA Change from Baseline? a +9.2 2q8 +8.8 8q12 +7.9 8q16 o ETDRS Letters a ° 12 20 24 28 32 36 40 4

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