Skip To Main Content
For Patients and Caregivers

How VABYSMO Works

Quick Links

MECHANISM OF DISEASE
PROPOSED MECHANISM OF ACTION
PEER PERSPECTIVES

There's more 2 the story of vascular leakage

Discover the role of Ang-2

MECHANISM OF DISEASE

2 pathways that drive retinal vascular disease

VEGF is not the only pathway driving disease5,6

Elevated Ang-2 is believed to independently drive vascular instability5,6*

Ang-2

VEGF

Ang-2 causes one of the earliest known events in disease, pericyte dropout, which leads to leakage and inflammation5-7*

Pericyte dropout
Driving leakage
Driving inflammation

Ang-2 levels are increased in some patients with nAMD, DME, and RVO.1

*Per preclinical models

Ang-2 sensitizes vessels to the effects of VEGF5,6,8*

Enhancing neovascularization and leakage

Ang-2 levels are increased in some patients with nAMD, DME, and RVO.1

*Per preclinical models

PROPOSED MECHANISM OF ACTION

Start with the power of 2

VABYSMO is the first and only dual-pathway treatment for nAMD, DME, and RVO1

VABYSMO suppressed Ang-2 and VEGF-A for up to 16 weeks after initial dosing1,9†

VABYSMO’s proposed mechanism of action
1

May reduce inflammation and vascular leakage1

2

Inhibits vascular leakage and neovascularization1

3

Engineered to reduce systemic exposure and potential for inflammation10

The contribution of Ang-2 inhibition to the clinical response for nAMD, DME, and RVO has yet to be established.1

†Pharmacodynamic analysis in aqueous humor of patients with nAMD or DME in Phase 2 and 3 trials: Ang-2 and VEGF-A levels did not return to baseline 16 weeks after a dose.9

PEER PERSPECTIVES

What are experts saying about the power of dual-pathway inhibition?

Ang-1=angiopoietin-1; Ang-2=angiopoietin-2; DME=diabetic macular edema; Fc=crystallizable fragment; nAMD=neovascular age-related macular degeneration; RVO=retinal vein occlusion; VEGF=vascular endothelial growth factor.

DRYING

How does drying drive your choice of first-line treatment?

Explore the data
NEXT: Study Design

Important Safety Information & Indications


INDICATIONS
VABYSMO (faricimab-svoa) is a vascular endothelial growth factor (VEGF) inhibitor and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), and Macular Edema following Retinal Vein Occlusion (RVO).


IMPORTANT SAFETY INFORMATION

Contraindications
VABYSMO is contraindicated in patients with ocular or periocular infection, in patients with active intraocular inflammation, and in patients with known hypersensitivity to faricimab or any of the excipients in VABYSMO. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.

Warnings and Precautions
Endophthalmitis and Retinal Detachments
Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection techniques must always be used when administering VABYSMO. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management.

Increase in Intraocular Pressure
Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including with VABYSMO. IOP and the perfusion of the optic nerve head should be monitored and managed appropriately.

Thromboembolic Events
Although there was a low rate of arterial thromboembolic events (ATEs) observed in the VABYSMO clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

The incidence of reported ATEs in the nAMD studies during the first year was 1% (7 out of 664) in patients treated with VABYSMO compared with 1% (6 out of 662) in patients treated with aflibercept.

The incidence of reported ATEs in the DME studies from baseline to week 100 was 5% (64 out of 1,262) in patients treated with VABYSMO compared with 5% (32 out of 625) in patients treated with aflibercept.

The incidence of reported ATEs in the RVO studies during the first 6 months was 1.1% (7 out of 641) in patients treated with VABYSMO compared with 1.4% (9 out of 635) in patients treated with aflibercept.

Retinal Vasculitis and/or Retinal Vascular Occlusion
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of VABYSMO. Healthcare providers should discontinue treatment with VABYSMO in patients who develop these events. Patients should be instructed to report any change in vision without delay.

Adverse Reactions
The most common adverse reactions (≥5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%).

Pregnancy, Lactation, Females and Males of Reproductive Potential
Based on the mechanism of action of VEGF and Ang-2 inhibitors, there is a potential risk to female reproductive capacity, and to embryo-fetal development. VABYSMO should not be used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VABYSMO and any potential adverse effects on the breastfed child from VABYSMO. Females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment and for at least 3 months following the last dose of VABYSMO.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in the full VABYSMO Prescribing Information.

    • 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.