Assessment and Limitations
Change from baseline in BCVA from week 24 through week 72 was a prespecified secondary endpoint.2
VABYSMO met its primary endpoint of non-inferiority vs aflibercept 2 mg in mean change from baseline in BCVA at week 24.1
Primary endpoint of non-inferiority vs aflibercept 2 mg in the mean change from baseline in BCVA was measured by the ETDRS letter score and tested using a margin of 4 letters. Differences in LS means for VABYSMO were -0.6 letters (CI: [95%] -2.2, +1.1) in BALATON; and -0.4 letters (CI: [95%] -2.5, +1.6) in COMINO. A non-inferiority margin was not available beyond week 24.1
The variable dosing in the OLE is not an approved dosing regimen. Approved dosing is 6 mg Q4W for 6 months.1
BCVA=best corrected visual acuity; BRVO=branch retinal vein occlusion; CI=confidence interval; CRVO=central retinal vein occlusion; ETDRS=Early Treatment Diabetic Retinopathy Study; LS=least squares; OLE=open-label extension; Q4W=every 4 weeks; RVO=retinal vein occlusion.
These experts are starting first with VABYSMO
VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2024.
VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2024.
Data on file. South San Francisco, CA: Genentech, Inc.
Data on file. South San Francisco, CA: Genentech, Inc.
Baumal CR, et al. Presented at American Academy of Ophthalmology (AAO) 2022. Sep 30–Oct 03 2022.
Baumal CR, et al. Presented at American Academy of Ophthalmology (AAO) 2022. Sep 30–Oct 03 2022.
Tadayoni R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2023. Feb 10–11 2023.
Tadayoni R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2023. Feb 10–11 2023.
Regula JT, et al. EMBO Mol Med. 2016;8:1265–1288.
Regula JT, et al. EMBO Mol Med. 2016;8:1265–1288.
Saharinen P, et al. Nat Rev Drug Discov. 2017;16:635–661.
Saharinen P, et al. Nat Rev Drug Discov. 2017;16:635–661.
Warmke N, et al. J Diabetes Complications. 2016;30:1643-1650.
Warmke N, et al. J Diabetes Complications. 2016;30:1643-1650.
Fiedler U, et al. Trends Immunol. 2006;27(12):552–558.
Fiedler U, et al. Trends Immunol. 2006;27(12):552–558.
Avery RL, et al. Presented at American Association of Ophthalmology (AAO) 2022. Sept 30–Oct 03 2022.
Avery RL, et al. Presented at American Association of Ophthalmology (AAO) 2022. Sept 30–Oct 03 2022.
Heier J, et al. Lancet. 2022;399(10326):729–740.
Heier J, et al. Lancet. 2022;399(10326):729–740.
Guymer R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2022. Feb 11–12 2022.
Guymer R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2022. Feb 11–12 2022.
Tadayoni R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2024. Feb 03 2024.
Tadayoni R, et al. Presented at Angiogenesis, Exudation, and Degeneration 2024. Feb 03 2024.
Khanani AM, et al. JAMA Ophthalmol. 2020;138(9):964–972.
Khanani AM, et al. JAMA Ophthalmol. 2020;138(9):964–972.
Sahni J, et al. Ophthalmology. 2019;126(8):1155–1170.
Sahni J, et al. Ophthalmology. 2019;126(8):1155–1170.
Wykoff C, et al. Lancet. 2022;399(10326):741–755.
Wykoff C, et al. Lancet. 2022;399(10326):741–755.
Heier JS, et al. Presented at American Academy of Ophthalmology Retina Subspecialty Day (AAO-SSD) 2021. Nov 12–13 2021.
Heier JS, et al. Presented at American Academy of Ophthalmology Retina Subspecialty Day (AAO-SSD) 2021. Nov 12–13 2021.
Goldberg R, et al. Presented at the Association for Research in Vision and Ophthalmology (ARVO) 2023. April 23–27 2023.
Goldberg R, et al. Presented at the Association for Research in Vision and Ophthalmology (ARVO) 2023. April 23–27 2023.
Baumal CR, et al. Presented at the Association for Research in Vision and Ophthalmology (ARVO) 2022. May 1–4 2022.
Baumal CR, et al. Presented at the Association for Research in Vision and Ophthalmology (ARVO) 2022. May 1–4 2022.
The information contained in this section of the site is intended for U.S. healthcare professionals only. Click "OK" if you are a healthcare professional.
I am a Healthcare Professional
I am a Patient or Caregiver
The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. makes no representation as to the accuracy of the information contained on sites we do not own or control. Genentech does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.