Phesgo and Tecentriq Performance and Approvals
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Vabysmo: Positive results in RVO presented at Angiogenesis 2023
Improvement in macular leakage compared to aflibercept
MIAMI
Macular leakage³
Roche
VABYSMO
Angiogenesis
2023
Faricimab 6.0 mg
(n=276)
Aflibercept 2.0 mg
(n=277)
COMINO
(C/HRVO)
BALATON
(BRVO)
Faricimab 6.0 mg
(n=366)
Aflibercept 2.0 mg
(n=363)
Adjusted Mean BCVA Change
From Baseline, ETDRS Letters
5
20
Ph III (BALATON/COMINO) results in RVO
BCVA¹
CST2
Week 24
16
Week 24
+16.9 letters
+17.5 letters
20
Week 24
+16.9 letters
+17.3 letters
1 2
16
20
24
Time, Weeks
Adjusted Mean CST Change
From Baseline, μm
-200
-300
1 2
Time, Weeks
Vabysmo achieved robust BCVA gains and reductions in CST across both studies
At week 24, more patients on Vabysmo achieved absence of macular leakage vs aflibercept
Results to be filed globally with regulatory authorities
16
-311.4 μm
-304.4 μm
20
Week 24
-461.6 μm
-448.8 μm
Proportion of Patients With Absence
of Macular Leakage
100%
80%
60%
33,6%
40%
20%
21.0%
I
0%
100%
80%
60%
44,4%
40%
30.0%
I
I
20%
0%
Week 24
1BCVA was measured using the ETDRS visual acuity chart at a starting distance of 4 m; 2CST is measured as ILM-BM, as graded by central reading center; ³Macular leakage was a pre-specified exploratory endpoint in BALATON/COMINO. Macular leakage
area within ETDRS grid was assessed by the reading center based on FA (fluorescein angiography) images obtained at baseline and predefined follow-up intervals, Absence is defined as area of leakage within the macula of 0 mm2 per FA; (B)RVO=(branch)
retinal vein occlusion; CRVO-central retinal vein occlusion; HRVO-hemiretinal vein occlusion; BCVA-best-corrected visual acuity; ETDRS-early treatment diabetic retinopathy study; CST-central subfield thickness; BM-Bruch's membrane; Eylea
(aflibercept) is a registered trademark/product of Regeneron
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