Income Statement Presentation 2023
Ophthalmology: Adding new indications
Positive Ph III results to be presented at Angiogenesis
VABYSMO
Vabsymo in RVO
Ph III (BALATON/COMINO)
susvim o™
Susvimo in DME
ranibizumab injection
susvimo™
ranibizumab injection
Ph III (PAGODA)
Week
Day 1 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72
Arm A
Faricimab 6.0 mg 6x
WEEK
Q4W followed by PTI
Arm B
Aflibercept 2.0 mg
6x Q4W followed by
faricimab PTI
PDS implantation and initial fill
Primary Endpoint
D1 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 112
Roche
Susvimo in DR
Ph III (PAVILION)
Primary Endpoint
IR virtual event
February 13th
MIAMI
16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 841 88
Angiogenesis
Feb 10-11
100 112 X
Y
Z Final
C
○
WEEK D1
4 8 12
Final
C
Arm A: PDS Q36W, N = 106
○ ○
OOOOOO
Arm A: PDS Q24W, n=381
PDS extension phase
Arm B: Monthly ranibizumab, n=253
Primary endpoint
at week 24
Core study end
at week 72
PDS implantation and initial filla
Fixed treatment interval
Faricimab PTI
Faricimab 6.0 mg
Faricimab 6.0 mg PTI/sham
Aflibercept 2.0 mg
Final study visit
O Intravitreal ranibizumab 0.5 mg loading dose
Intravitreal ranibizumab 0.5 mg
☐
PDS implantation and initial fill
POS refill-exchange
°
Patients assessed for supplemental treatment O
Visit with no refill-exchange or intravitreal ranibizumab
00 O O O
Refill-exchange
interval 36 weeks
post-implantation
Arm B: Control (observation³), N = 68
O O O
PDS extension phase
Intravitreal ranibizumab 0.5 mg
PDS refill-exchange
PDS implantation and initial fillb
○
Visit with no refill-exchange or intravitreal ranibizumab
Primary
endpoint
Change from baseline in BCVA at
week 24
Primary
endpoint
BCVA score change from baseline
averaged over weeks 60 and 64 as
measured via ETDRS chart
Primary
endpoint
Percentage of patients with a ≥2-
step improvement from baseline on
the ETDRS-DRSS at week 52
•
All studies met their respective primary endpoints; safety profiles were consistent with previous trials
•
Results to be presented at the Angiogenesis virtual medical meeting (Feb 10-11)
•
IR virtual event planned for Feb 13th (4:30-5:30pm CET/7:30 - 8:30am PST); clinical results to be presented by Veeral Sheth, MD (retinal
specialist and clinical investigator)
(B/C)RVO=(branch/central) retinal vein occlusion; BCVA-best-corrected visual acuity; HRVO=hemiretinal vein occlusion; CST=central subfield thickness; PTI=personalized treatment interval; QXW-every X weeks; PDS=port delivery
system; DME=diabetic macular edema; nAMD=neovascular age-related macular degeneration; DR-diabetic retinopathy; EDTRS(-DRSS)-early treatment diabetic retinopathy study (-diabetic retinopathy severity scale); Eylea
(aflibercept) is a registered trademark/product of Regeneron
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