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†
VABYSMO achieved CST reductions in all 3 indications over 2 years in DME, 1 year in nAMD, and 6 months in RVO2-4‡
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
to start VABYSMO as their first branded treatment¶
for drug and administration for eligible commercially insured patients#
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.
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.
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