Skip To Main Content

THE POWER 2 OPEN THEIR WORLD

START FIRST with dual-pathway VABYSMO

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

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

Powerful first-line efficacy1

VABYSMO met its primary endpoint of non-inferiority vs aflibercept 2 mg in the mean change from baseline in BCVA across nAMD, DME, and RVO1

Rapid and sustained drying2-4

VABYSMO achieved CST reductions in all 3 indications over 2 years in DME, 1 year in nAMD, and 6 months in RVO2-4

Flexible 1–4 month dosing1

Extended dosing intervals driven by CST and visual acuity in nAMD and DME1§

Monthly dosing for 6 months in RVO1

*Macular edema following retinal vein occlusion (RVO).
Primary endpoint was measured by the ETDRS letter score and tested for non-inferiority using a margin of 4 letters. nAMD: VABYSMO met its primary endpoint of non-inferiority at year 1 (avg. of weeks 40, 44, and 48). Differences in LS means for VABYSMO were +0.7 letters (CI: [95%] -1.1, +2.5) in TENAYA; and 0.0 letters (CI: [95%] -1.7, +1.8) in LUCERNE. DME: VABYSMO met its primary endpoint of non-inferiority at year 1 (avg. of weeks 48, 52, and 56). Differences in LS means in YOSEMITE were +0.7 letters (CI: [97.5%] -1.1, +2.5) for VABYSMO Q4W–Q16W and -0.2 letters (CI: [97.5%] -2.0, +1.6) for VABYSMO Q8W. Differences in LS means in RHINE were +0.5 letters (CI: [97.5%] -1.1, +2.1) for VABYSMO Q4W–Q16W and +1.5 letters (CI: [97.5%] -0.1, +3.2) for VABYSMO Q8W. A non-inferiority margin was not available for year 2. RVO: VABYSMO met its primary endpoint of non-inferiority at week 24. Differences in LS means for VABYSMO were -0.6 letters (CI: [95%] -2.2, +1.1) in BALATON (BRVO); and -0.4 letters (CI: [95%] -2.5, +1.6) in COMINO (CRVO).1
Reductions in CST over time were prespecified secondary endpoints. Reductions in CST were observed across all treatment arms throughout the six Phase 3 studies in nAMD, DME, and RVO.1
§
Recommended dosing is 4 or 6 (DME only) monthly loading doses followed by 1–4 month dosing in nAMD and DME.1

The access you need for the dosing they need

The access you need for the dosing they need
VABYSMO payer coverage

~90% of patients covered

to start VABYSMO as their first branded treatment

VABYSMO patient-support

As little as $0 co-pay

for drug and administration for eligible commercially insured patients#

VABYSMO provider-access

Access VABYSMO

with our discount and rebate programs

Coverage determined for VABYSMO vial based on Medicare Fee for Service and tracking of the largest payers for other books of business. Bevacizumab (not indicated for intraocular use) and biosimilars are excluded from the branded treatment category. Specific coverage may vary for individuals and plans. Data as of January 2024.
#Effective December 1, 2022. The Product and Administration Co-pay Programs are valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medicine. Patients using Medicare, Medicaid or any other federal or state government program (collectively, “Government Programs”) to pay for their Genentech medicine and/or administration services are not eligible. Under the Programs, the patient may pay a co-pay for drug costs and a co-pay for administration costs. The final amount owed by a patient may be as little as $0 for the Genentech medicine or administration of the Genentech medicine (see Program specific details). The total patient out-of-pocket cost is dependent on the patient’s health insurance plan. The Programs assist with the cost of the Genentech medicine and the Genentech medicine administration only. It does not assist with the cost of other administrations, medicines, procedures or office visit fees. After reaching the maximum Programs’ benefit amounts, the patient will be responsible for all remaining out-of-pocket expenses. The amount of the Programs’ benefits cannot exceed the patient’s out-of-pocket expenses for the cost of the Genentech medicine or administration fees associated with the Genentech medicine. All participants are responsible for reporting the receipt of all Programs’ benefits as required by any insurer or by law. The Programs are only valid in the United States and U.S. Territories and are void where prohibited by law. The Drug Co-pay Program shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. The Administration Co-pay Program is not valid for Massachusetts or Rhode Island residents. No party may seek reimbursement for all or any part of the benefit received through the Programs. The Programs are intended for the patient. Only the patient using the Programs may receive the funds made available through the Programs. The Programs are not intended for third parties who reduce the amount available to the patient or take a portion for their own purposes. Patients with health plans that redirect Genentech Program assistance intended for patient out-of-pocket costs may be subject to alternate Program benefit structures. Genentech reserves the right to rescind, revoke or amend the Programs without notice at any time. Additional terms and conditions apply. Please visit EyeOnCopay.com for the full list of Terms and Conditions.

BCVA=best corrected visual acuity; BRVO=branch retinal vein occlusion; CI=confidence interval; CRVO=central retinal vein occlusion; CST=central subfield thickness; DME=diabetic macular edema; ETDRS=Early Treatment Diabetic Retinopathy Study; LS=least squares; nAMD=neovascular age-related macular degeneration; Q4W=every 4 weeks; Q8W=every 8 weeks; Q16W=every 16 weeks; RVO=retinal vein occlusion.

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.