YOSEMITE and RHINE: 2 large, Phase 3, 2-year, randomized, double-masked multicenter, active-comparator-controlled studies1,10
A total of 1891 diabetic patients were enrolled in the 2 studies, with a total of 1262 patients treated with at least 1 dose of VABYSMO. Patient ages ranged from 24 to 91, with a mean of 62.2 years. The overall population included both anti-VEGF naïve patients (78%) and patients who had been previously treated with a VEGF inhibitor prior to study participation (22%).1
The utility of these disease activity criteria to guide dosing intervals has not been established.
aAfter week 12, patients continued on Q4W until CST <325 μm was achieved.12
Reference CST was defined as the CST value when the original reference value (CST <325 μm on Spectralis SD-OCT, <315 μm on Cirrus SD-OCT or Topcon SD-OCT) was met.
Reference CST was adjusted if CST decreased by >10% from the previous reference CST for 2 consecutive study drug dosing visits and the values obtained were within 30 μm.
The CST value obtained at the latter visit served as the new reference CST.12
bRegardless of BCVA increase or decrease, intervals were maintained.
cUnless accompanied by ≥10-letter decrease from reference BCVA (then interval maintained).12
dUnless CST increased 10-20% and accompanied by BCVA improvement or decrease <5 letters (then interval maintained).12
eReference BCVA was defined as the mean of the 3 best scores obtained at any prior study drug dosing visit.12
BCVA=best corrected visual acuity; CST=central subfield thickness; DME=diabetic macular edema; IVT=intravitreal; OCT=optical coherence tomography; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks; R 1:1:1=one-to-one-to-one ratio; SD-OCT=spectral domain-optical coherence tomography; VEGF=vascular endothelial growth factor.
*VABYSMO adjustable dosing based on disease activity measurements. Patients in this arm could have received between 3 and 11 total injections through week 56.1
VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2022.
VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2022.
Beovu® (brolucizumab) [package insert]. East Hanover, NJ: Novartis; 2020.
Beovu® (brolucizumab) [package insert]. East Hanover, NJ: Novartis; 2020.
Eylea® (aflibercept) [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2021.
Eylea® (aflibercept) [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2021.
LUCENTIS® (ranibizumab) [package insert]. South San Francisco, CA: Genentech, Inc; 2018.
LUCENTIS® (ranibizumab) [package insert]. South San Francisco, CA: Genentech, Inc; 2018.
SUSVIMO™ (ranibizumab injection) [package insert]. South San Francisco, CA: Genentech, Inc; 2022.
SUSVIMO™ (ranibizumab injection) [package insert]. South San Francisco, CA: Genentech, Inc; 2022.
Saharinen P, et al. Nat Rev Drug Discov. 2017;16:635-661.
Saharinen P, et al. Nat Rev Drug Discov. 2017;16:635-661.
Fiedler U, et al. Trends Immunol. 2006;27:552-558.
Fiedler U, et al. Trends Immunol. 2006;27:552-558.
Mueller SB, et al. J Clin Invest. 2016;126:3188-3191.
Mueller SB, et al. J Clin Invest. 2016;126:3188-3191.
Hakanpaa L, et al. Nat Commun. 2015;6:5962.
Hakanpaa L, et al. Nat Commun. 2015;6:5962.
Wykoff C, et al. Lancet. Published online January 24, 2022. doi:10.1016/S0140-6736(22)00018-6
Wykoff C, et al. Lancet. Published online January 24, 2022. doi:10.1016/S0140-6736(22)00018-6
Heier J, et al. Lancet. Published online January 24, 2022. doi:10.1016/S0140-6736(22)00010-1
Heier J, et al. Lancet. Published online January 24, 2022. doi:10.1016/S0140-6736(22)00010-1
Data on file. South San Francisco, CA: Genentech, Inc.
Data on file. South San Francisco, CA: Genentech, Inc.
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