Slide 1: Intravitreal Aflibercept 8 mg in Patients with PCV: PULSAR Subgroup Analysis
Intravitreal Aflibercept 8 mg in Patients with Polypoidal Choroidal Vasculopathy (PCV): A Phase 3 PULSAR Trial Subgroup Analysis Michael Singer,1 on behalf of the PULSAR study investigators 1Medical Center of Ophthalmology, University of Texas Health Science Center, San Antonio, Texas, USA Presented
Slide 2: Disclosures
Disclosures AMD • Michael Singer reports consulting fees for Aerie, Biogen Bausch, Alimera, Adverum, Allergan, Eyepoint, Genentech, Novartis, Ocular Therapeutics, Regeneron Pharmaceuticals, Inc., and Eyepoint; has served on speakers bureau for Allergan, Eyepoint, Genentech, Eyepoint, Regeneron Pharm
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
Slide 4: PULSAR: Dosing Schedule and Regimen Modification in Year 1
PULSAR: Dosing Schedule and Regimen Modification in Year 1 AMD
Slide 5: PCV in PULSAR
PCV in PULSAR * PULSAR is a global study conducted across 223 sites in 27 countries * ICGA was optional and conducted in 295 patients in 12 countries? — PCV present: n=139 — PCV absent: n=153 — Data missing: n=3 Race of PCV subgroup? Not reported 0.7% (n=1) ICGA images were graded by the reading cen
Slide 6: Baseline Demographics and Disease Characteristics
Baseline Demographics and Disease Characteristics AMD
Slide 7: Absolute BCVA and Change from Baseline in BCVA Through Week 48
Absolute BCVA and Change from Baseline in BCVA Through Week 48 AMD
Slide 8: Proportions of Patients Maintained on Q12 and Q16 Dosing Intervals Through Week 48
Proportions of Patients Maintained on Q12 and Q16 Dosing Intervals Through Week 48 AMD
Slide 9: Proportion of Patients Without Retinal Fluid in the Center Subfield At Week 16
Proportion of Patients Without Retinal Fluid in the Center Subfield At Week 16 AMD
Slide 10: Absolute CST Through Week 48
Absolute CST Through Week 48 AMD
Slide 11: PCV Subgroup: Proportion of Patients with Polyps
PCV Subgroup: Proportion of Patients with Polyps AMD
Slide 12: PCV Subgroup: Proportion of Patients with Active Polyps
PCV Subgroup: Proportion of Patients with Active Polyps AMD
Slide 13: PCV Subgroup: Absolute Macular Volume
PCV Subgroup: Absolute Macular Volume AMD
Slide 14: Safety Through Week 48
Safety Through Week 48 PCV Subgroup Overall Population 2q8 8q12 6q1655 All 8mg 2q8 8q12 6q1655 All 8 mg (n=54) (n=44) (n=41) (n=85) (n=336) | (n=335) )(=338)) (n=673) Any ocular TEAE, n (%) 14 (25.9) | 17(38.6) 13(31.7) 30(35.3) REQReERsw EPSNeeton RacLAon Pecckern) Reduced visual acuity 3 (5.6) 2 (
Slide 15: Conclusions: Aflibercept 8 mg Monotherapy in PCV
Conclusions: Aflibercept 8 mg Monotherapy in PCV AMD
Slide 16: PULSAR: 96-week Results
PULSAR: 96-week Results Aflibercept 8 mg groups achieved similar BCVA gains compared with the aflibercept 2 mg group at Week 96 + Anatomic improvement in PULSAR for aflibercept 8 mg was generally maintained over time at Week 96 + At Week 96, 89% of patients receiving aflibercept 8q16 achieved 2Q12 d