Pharma Update
Susvimo: Adding new indications
Positive Ph III results in DME and DR with filing in 2024
Ph III in DME (PAGODA)1
Angiogenesis
Feb 10-11
MIAMI
Ph III in DR (PAVILION)²
Adj. mean change
from baseline in
BCVA score, (95% CI)
PDS 100 mg/mL
Q24W
IVT ranibizumab
Averaged
over weeks
Difference in adjusted means for BCVA change
averaged over weeks 60 and 64, 95% CI
60 and 64
9.6
(8.7, 10.5)
NI
margin,
-4.5 L
0.5 mg Q4W
Difference in
adj. means
9.4
(8.3, 10.5)
Primary
endpoint
0.2
(-1.2, 1.6)
-10 -8
-6 -4 -2
0
2
4
6
8
10
ETDRS letters
Intravitreal ranibizumab
PDS 100 mg/mL
0.5 mg Q4W better
Q24W better
BCVA score change from baseline
averaged over weeks 60 and 64 as
measured via ETDRS chart
Proportion of Patients (CMH Weighted
Estimate at Week 52,a) %
100
75
Patients with ≥ 2-step improvement from
baseline on ETDRS-DRSS, ITT population
50
80.1%
25
PDS 100 mg/mL Q36W
(n = 106)
Primary
endpoint
Difference: 71.1%
(95% CI, 61.0%-81.2%; P = < 0.0001b)
9.0%
Control
(n = 68)
Percentage of patients with a >2-
step improvement from baseline on
the ETDRS-DRSS at week 52
Roche
sus vimo
ranibizumab injection Forcular implant
100mg/ml.
1. Khanani et al. Angiogenesis 2023; 2. Pieramici et al. Angiogenesis 2023; aThe weighted estimate based on CMH method was stratified by baseline ETDRS-DRSS level (47 vs 53) and baseline intraretinal or subretinal fluid status (present vs
absent).Missing ETDRS-DRSS is imputed using the last observed outcome prior to week 52. Patients with missing baseline outcomes are excluded. bCMH test; DME=Diabetic macular edema; DR=Diabetic retinopathy; BCVA-Best corrected visual acuity;
ETDRS-Early treatment of diabetic retinopathy study; DRSS-Diabetic retinopathy severity scale; PDS-Port delivery system with ranibizumab; Cl=Confidence interval; IVT=Intravitreal; ITT=Intention to treat; Q24W-Every 24 weeks; Q4W-Every 4 weeks;
Q36W-Every 36 weeks
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