Slide 1: Intravitreal Aflibercept 8 mg Injection in Patients With nAMD: 60-Week and 96-Week PULSAR Results
Intravitreal Aflibercept 8 mg Injection in Patients With Neovascular Age-Related Macular Degeneration: 60-Week and 96-Week Results from the Phase 3 PULSAR Trial Paolo Lanzetta,1 Andrea Schulze,2 Ursula Schmidt-Ott,2 Xin Zhang,3 Alyson Berliner,4 Karen Chu,4 Kimberly Reed,4 Robert Vitti,4 Sergio Leal
Slide 2: Disclosures
Disclosures nAMD • PL: Consultant for Aerie, Allergan, Apellis, Bausch + Lomb, Bayer, Biogen, Boehringer Ingelheim, I-Care, Genentech, Novartis, Ocular Therapeutix, Outlook Therapeutics, and Roche o AS: Employee of Bayer AG. USO: Employee of Bayer AG, stockholder of Bayer AG. XZ and SL: Employees of
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
Slide 4: PULSAR: Dosing Schedule and Regimen Modification
PULSAR: Dosing Schedule and Regimen Modification Primary nAMD endpoint
Slide 5: Patient Disposition and Baseline Characteristics
Patient Disposition and Baseline Characteristics nAMD
Slide 6: BCVA Outcomes
BCVA Outcomes ulsa nAMD BCVA Change from BL (LS Means)? omc WEeG (Eee 2948 +7.0 | +7.2 | +6.6 8q12 | +6.1 | +6.4 | +5.6 +5.9 | +6.3 | +5.5 a eo BCVA (ETDRS letters) a 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 N 3° a 55 a 0 4 8 12 16
Slide 7: Central Subfield Thickness
Central Subfield Thickness nAMD
Slide 8: Last Assigned Dosing Interval at Week 60 and Week 96
Last Assigned Dosing Interval at Week 60 and Week 96a nAMD
Slide 9: Safety Through Week 60
Safety Through Week 60 N (SAF) Ocular safety Patients with 21 ocular TEAE? Patients with 21 1O] TEAE Patients with IOP 235 mmHg pre- or post-injection Non-ocular safety APTC events’ Hypertension events? Non-ocular SAEs? Deaths* * Ocular TEAEs occurring in 23% of patients in any treatment group were
Slide 10: PULSAR: 60- and 96-Week Results
PULSAR: 60- and 96-Week Results nAMD • Aflibercept 8 mg groups achieved similar BCVA gains compared with the aflibercept 2 mg group at Weeks 60 and 96 • Anatomic improvement in PULSAR for aflibercept 8 mg was generally maintained over time at Weeks 60 and 96 • At Weeks 60 and 96 respectively, 91% an