Bayer Ag · XETR:BAYN

Bayer — Technical Presentation (February 2024)

12 slides from Bayer's technical presentation, February 2024

  1. Slide 1: Intravitreal Aflibercept 8 mg in Patients With PCV: 96-week PULSAR Subgroup Analysis

    Intravitreal Aflibercept 8 mg in Patients With Polypoidal Choroidal Vasculopathy (PCV): A 96-week Phase 3 PULSAR Trial Subgroup Analysis Chui Ming Gemmy Cheung,'? Tien Yin Wong,'? Jeffrey S Heier,’ Xin Zhang,> Tobias Machewitz,® Andrea Schulze,® Sergio Leal,5 on behalf of the PULSAR study investigat

  2. Slide 2: Disclosures

    Disclosures * CMGC: Consultant fees, speaker fees, and grant funding from Avirmax, Bayer, Boehringer Ingelheim, Janssen, Novartis, Roche, Topcon, and Zeiss o TYW: Consultant fees from Bayer, Boehringer-Ingelheim, Eden Ophthalmic, Genentech, Iveric Bio, Novartis, Roche, Shanghai Henlius, and Zhaoke P

  3. Slide 3: PULSAR: Multicenter, randomized, double-masked study

    ULSAR: Multicenter, randomized, double-masked study © Patients with treatment-naive nAMD, randomized at baseline 7 P nAMD 2q8 Aflibercept 2 mg every 8 weeks after 3 initial monthly injections n=336 v 8q12 Aflibercept 8 mg every 12 weeks after 3 initial monthly injections n=335 v 8q16 Aflibercept 8 m

  4. Slide 4: PULSAR: ICGA-Confirmed PCV in Patients

    PULSAR: ICGA-Confirmed PCV in 139 Patients « PULSAR is a global study conducted across 223 sites in 27 countries « ICGA was optional and conducted in 296 patients in 13 countries# * PCV present, n=139; PCV absent, n=154 * PCV could not be graded in 3 patients : ice PCV Subgroup (ICGA-confirmed) Over

  5. Slide 5: Change in BCVA Through Week 96: Similar With 8q12 and 8q16 Versus 2q8

    Change in BCVA (ETDRS letters) So Og ao Em ow 2a ot ecw ou a o a ° ono & Change in BCVA Through Week 96: Similar With 8q12 and 8q16 Versus 2q8 PCV Subgroup Week 48 Week 96 BL Week 48 Week 96 2q8 (n=54) 57.6 +9.3 +9.6 8q12 (n=44) 56.3 +9.5 +8.4 8q16 (n=41) 60.1 +7.5 +8.2 0 4 81 2 16 20 24 28 32 36 40

  6. Slide 6: CST Through Week 96: Similar with 8q12 and 8q16 Versus 2q8

    CST Through Week 96: Similar with 8q12 and 8q16 Versus 2q8 PCV Subgroup Week 48 Week 96 298 (n=54) 216 | 207 8qi2(n=4a) | 219 | 219 8q16(n=41) | 230 | 232 Absolute CST (um) 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 9 Week Overall Population Week 48 Week 96 2q8 (n=335) 236 | 225

  7. Slide 7: Retinal Fluid Through Week 96: Marked Increase in Patients Without Retinal Fluid

    Retinal Fluid Through Week 96: Marked Increase in Proportion of Patients Without Retinal Fluid PCV Subgroup m2q8 m8q12 =8qi6 mAIl8mg 2 ° Q °o a o ~ 2s oc 2s e353 lo OG cf 28 tw os 265 2s a: Baseline G, LOCF (data post ICE were censored). “Without retinal fluid” defined as absence ofintraretinal and

  8. Slide 8: Dosing Interval Extension in Year 2: Most Patients with PCV Qualified

    Dosing Interval Extension in Year 2?: Most Patients with PCV Qualified for Extension Last Assigned Dosing Interval (PCV Subgroup) mq8 mqi2 mqi6 mq20 mq24 PCV Subgroup? Mean number of injections from baseline to Week 96 2q8 8q12 8q16 12.7 9.7 7.7 & 2 @ ro & e| @ a ie S & = fe) a fe) 2 fal, Randomized

  9. Slide 9: Polypoidal Lesions Through Week 48

    Polypoidal Lesions Through Week 48 ~50% of patients had no polypoidal lesions at Week 48? 278% of patients had no active polypoidal lesions?" at Week 48 94% 97% 22% Patients with number of polypoidal lesions Proportion of patients (%) with active polypoidal lesions 3% 2q8 All8mg; 28 All 8 mg ' Scree

  10. Slide 10: Total Area of Polypoidal Lesions: Similar Change From Baseline Through Week 96

    Total Area of Polypoidal Lesions: Similar Change From Baseline Through Week 96 PCV Subgroup m2q8 m8q12 = 8q16 EX} BL (mm?)= 308) im S — © = Oo D © a Hl ° ° € £ 9 2 ® & © D c @ xo oO Ditia.are for patients with PCV who completed Week 96.

  11. Slide 11: 96-Week Ocular Safety Profile of Aflibercept 8 mg

    96-Week Ocular Safety Profile of Aflibercept 8 mg: Similar to 2 mg in PCV and Overall Populations PCV subgroup TEAE, n (%) in study eye 2q8 All8mg 2q8 Any ocular TEAE 21 (38.9) 20(45.5) 20(48.8) 40(47.1) BESNGSXOMMWANGHRO) RECRGHE)) Icy CECH) Any intraocular inflammation TEAE 1 (1.9) 1 (2.3) cree 6

  12. Slide 12: Conclusions: Aflibercept 8 mg Monotherapy in PCV

    Conclusions: Aflibercept 8 mg Monotherapy in PCV Visual acuity gains from baseline were largely maintained from Week 48 to Week 96 in the aflibercept 8q12, 8q16, and 2q8 PCV subgroups, with gains of +8.4, +8.2, and +9.6 letters, respectively, from baseline to Week 96 Through Week 96, the absolute an

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