Roche Pharmaceutical Development and Sales Overview slide image

Roche Pharmaceutical Development and Sales Overview

Susvimo (PDS, RG6321) First eye implant to achieve sustained delivery of a biologic medicine Indication Wet age-related macular degeneration (wAMD) Roche Phase/study # of patients Design Phase III Archway N=418 ARM A: Port delivery system with ranibizumab q24w ARM B: Intravitreal ranibizumab q4w 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 Primary endpoint Status CT Identifier Change in BCVA from baseline at the average of week 36 and week 40 ☐ FPI Q3 2018 ■ 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 " 1 Safety and long term efficacy FPI Q3 2018 Change in BCVA from baseline averaged over weeks 68 and 72 FPI Q3 2021 NCT03683251 NCT04657289 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 97 97 Ophthalmology
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