Skip To Main Content

Drying

VABYSMO met its primary endpoint of non-inferiority vs aflibercept 2 mg in the mean change from baseline in BCVA at week 24¹

Please see additional information on the Vision page

Rapid and sustained CST reductions

maintained through week 72^2,13

Mean change in CST from baseline (secondary endpoint)^2,13

Mean change in CST from baseline to week 72 in BRVO

Assessment and Limitations
Reduction in CST (ILM-BM) over time was a prespecified secondary endpoint.²

Clinical significance has not been established, and conclusions regarding treatment effects cannot be drawn.
The OLE lacked a comparator arm and therefore no conclusion around efficacy can be established.
The variable dosing in the OLE is not an approved dosing regimen. Approved dosing is 6 mg Q4W for 6 months.¹

Mean change in CST from baseline to week 72 in CRVO

Discover the study design and variable dosing in the OLE phase

The variable dosing in the OLE is not an approved dosing regimen. Approved dosing is 6 mg Q4W for 6 months.¹

Resolution of macular leakage¹⁵

Beyond the OCT: absence of macular leakage as a marker of drying¹⁵

Fluorescein angiographic images of an RVO patient treated with VABYSMO¹⁵

Fluorescein angiographic images of an RVO patient treated with VABYSMO

Macular leakage was assessed by the reading center based on fluorescein angiographic images. Resolution was defined as a leakage area of 0mm² within an ETDRS grid.¹⁵

Individual results may vary. No serious ocular adverse drug reactions were observed/reported in the treated eye.

Resolution of macular leakage at week 24 (prespecified exploratory endpoint)²*

Resolution of macular leakage at week 24 in RVO

Assessment and Limitations
Resolution of macular leakage was a prespecified exploratory endpoint.²

The statistical significance of these results cannot be determined and the clinical significance of these results is unknown.

*Fundus fluorescein angiographic images were collected and assessed at baseline and predefined follow-up intervals. This analysis only included study patients with evaluable fluorescein angiography data.

Have you explored all of the VABYSMO drying data?

Why compromise between drying and durability in your go-to treatment?

Join Dr. Veeral Sheth and Dr. Katherine Talcott as they discuss the link between drying and durability, and how these factors determine their go-to treatment.

BCVA=best corrected visual acuity; BRVO=branch retinal vein occlusion; CRVO=central retinal vein occlusion; CST=central subfield thickness; DME=diabetic macular edema; ETDRS=Early Treatment Diabetic Retinopathy Study; ILM-BM=inner limiting membrane-Bruch's membrane; ILM-RPE=inner limiting membrane-retinal pigment epithelium; IRF=intraretinal fluid; nAMD=neovascular age-related macular degeneration; OLE=open-label extension; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks; RVO=retinal vein occlusion; SRF=subretinal fluid.

PEER PERSPECTIVES

How does drying drive your choice of preferred treatment?

Hear from experts

THE ACCESS YOU NEED
FOR THE DOSING THEY NEED

Explore VABYSMO’s payer coverage and see how you can start first

NEXT: Durability

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.
- London NJS, et al. Presented at Hawaiian Eye and Retina Meeting 2025. Jan 18–24 2025.
  
  London NJS, et al. Presented at Hawaiian Eye and Retina Meeting 2025. Jan 18–24 2025.
- Wykoff C, et al. Lancet. 2022;399(10326):741–755.
  
  Wykoff C, et al. Lancet. 2022;399(10326):741–755.
- 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.
- 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.
- 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.
- 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.
- 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.