Roche Pharmaceutical Development and Sales Overview
Susvimo (PDS, RG6321)
First eye implant to achieve sustained delivery of a biologic medicine
Indication
Diabetic macular edema (DME)
Diabetic retinopathy (DR) without
center-involved diabetic macular edema (DME)
Phase/study
# of patients
Design
Primary endpoint
Status
CT Identifier
Phase III
Pagoda
N=545
"
ARM A: Port delivery system with ranibizumab q24w
"
ARM B: Intravitreal ranibizumab q4w
Change in BCVA from baseline at the average of week 48 and week 52
ā
FPI Q3 2019
Recruitment completed Q2 2021
NCT04108156
Phase III
Pavilion
N=160
Roche
ARM A: Intravitreal ranibizumab (X2) followed by PDS implant (refill
936w)
ARM B: Q4w comprehensive clinical monitoring until participants receive
PDS (refill q36w)
Percentage of participants with a ā„2-step improvement from baseline on
the ETDRS-DRSS at Week 52
"
FPI Q3 2020
Recruitment completed Q3 2021
BCVA=best corrected visual acuity; ETDRS-Early Treatment Diabetic Retinopathy Study; DRSS-Diabetic Retinopathy Severity Scale; PDS-Port Delivery System with ranibizumab
NCT04503551
98
OphthalmologyView entire presentation