Half-Year 2022 Financial and Clinical Trials Update
Susvimo (PDS)
First eye implant to achieve sustained delivery of a biologic medicine
Indication
Wet age-related macular degeneration (wAMD)
Phase/study
# of patients
Design
Phase III
Archway
N=418
ARM A: Port delivery system with ranibizumab
q24w
■
ARM B: Intravitreal ranibizumab q4w
Roche
Phase II+III extension
Portal
N=1,000
Patients from LADDER or Archway will receive
refills of 100mg/mL ranibizumab q24w (patients
without the PDS will receive the PDS and
subsequent refills)
Phase Illb
Velodrome
N=442
- ARM A: Port delivery system with ranibizumab
936w
▪ ARM B: Port delivery system with ranibizumab
q24w
Change in BCVA from baseline at the average of ▪ Safety and long term efficacy
week 36 and week 40
Primary endpoint
FPI Q3 2018
FPI Q3 2018
■ Change in BCVA from baseline averaged over
weeks 68 and 72
FPI Q3 2021
Status
CT Identifier
Recruitment completed Q2 2019
▪ Study met primary endpoint Q2 2020
Primary endpoint data presented at ASRS 2020,
44/48 week data at Angiogenesis 2021 and 2-
year data at Angiogenesis 2022
Filed in US (PRIME) and EU Q2 2021
▪ Approved in US Q4 2021
NCT03677934
NCT03683251
NCT04657289
119
BCVA=best corrected visual acuity; wAMD-wet age-related macular degeneration; ASRS-American Society of Retinal Specialists; PDS-Port Delivery System with ranibizumab; PRIME=Priority review
OphthalmologyView entire presentation