Slide 1: Aflibercept 8 mg in Polypoidal Choroidal Vasculopathy: PULSAR subgroup analysis
Aflibercept 8 mg in Polypoidal Choroidal Vasculopathy: PULSAR subgroup analysis Tomohiro Iida, on behalf of the PULSAR study investigators Tokyo Women's Medical University, Shinjuku-ku, Tokyo, Japan Presented at the 77th Annual Congress of Japan Clinical Ophthalmology, Tokyo, Japan, October 6–9, 202
Slide 2: Financial Disclosure
Japanese Ophthalmological Society Financial Disclosure First Author: Tomohiro Iida 【Conflict of Interest】 Tomohiro Iida: 【F】 Nidec, Topcon, Santen 【P】 The PULSAR study was sponsored by Bayer AG (Leverkusen, Germany) and co-funded by Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA). The sponsor p
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 Study Design and Dosing Schedule
PULSAR Study Design and Dosing Schedule nAMD
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 Patients with PCV present (ICGA-confirmed) PCV subgroup by race” Europe 18 APAC 100 Ame
Slide 6: PCV subgroup: Baseline demographics and disease characteristics
PCV subgroup: Baseline demographics and disease characteristics nAMD
Slide 7: PCV Subgroup: Absolute and Change from Baseline in BCVA through Week 48 (LOCF)
PCV Subgroup: Absolute and Change from Baseline in BCVA through Week 48 (LOCF) nAMD
Slide 8: PCV Subgroup: Proportions of Patients Maintained on Q12 and Q16 Dosing Intervals through Week 48
PCV Subgroup: Proportions of Patients Maintained on Q12 and Q16 Dosing Intervals through Week 48 nAMD
Slide 9: PCV Subgroup: Anatomic Endpoints
PCV Subgroup: Anatomic Endpoints nAMD
Slide 10: PCV subgroup: Additional analyses
PCV subgroup: Additional analyses nAMD
Slide 11: PCV subgroup: Safety – Week 48
PCV subgroup: Safety – Week 48 nAMD
Slide 12: PCV subgroup: Non-Ocular safety through Week 48
PCV subgroup: Non-Ocular safety through Week 48 nAMD
Slide 13: Conclusions
Conclusions: Aflibercept 8 mg monotherapy in PCV nAMD