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VISION GAINS

VABYSMO Delivered Rapid & Sustained Vision Gains With Extended Dosing Intervals at Year 11*

Mean change in BCVA from baseline to week 48 in nAMD1,11


Mean change in BCVA from baseline to week 48 in nAMD (chart)

Primary endpoint was defined as the mean change from baseline in BCVA (measured by the ETDRS letter score) at year 1 (based on an average of weeks 40, 44, and 48) and was tested for non-inferiority using a margin of 4 letters.1

VABYSMO met its primary endpoint vs aflibercept Q8W (FDA-approved dosing regimen)1,3

*After 4 monthly loading doses. The clinical efficacy for the second year of these studies has not been reviewed.1

BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Study; ITT=intent to treat; LS=least squares; nAMD=neovascular age-related macular degeneration; Q8W=every 8 weeks; Q16W=every 16 weeks.

TREATMENT INTERVALS

Proportion of VABYSMO Patients Achieving Q12W and Q16W in nAMD at Year 11

VABYSMO patients on each dosing interval at week 481


TENAYA and LUCERNE Pooled (n=664) 45% Q16W 33% Q12W 22% Q8W
  • The percentages may not be generalizable to a broader nAMD population for a variety of reasons. The inclusion/exclusion criteria limited enrollment to a select subset of treatment-naïve, newly diagnosed nAMD patients, and there are no empirical data that a similar magnitude would be observed if eligibility criteria allowed for broader enrollment1
  • The disease activity criteria, which were instrumental in determining dose frequency, were unvalidated. Stricter criteria would have changed how patients were treated resulting in different percentages of subjects in each dose interval cohort. There was not a similarly dosed aflibercept arm for comparison, which makes the percentages difficult to interpret1

nAMD=neovascular age-related macular degeneration; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks.

ANATOMICAL OUTCOMES

Reductions in CST Were Observed Across All Treatment Arms (Secondary Endpoint)1

Change in CST from baseline through week 48 in nAMD1,12


Change in CST from baseline through week 48 in nAMD (chart)

Assessment and Limitations:

Reduction in CST (ILM-RPE) over time were a prespecified secondary endpoint. P values (for superiority testing) are nominal and not adjusted for multiplicity; no formal statistical conclusion should be made based on the P values. Clinical significance has not been established, and conclusions regarding treatment effect cannot be drawn.12

CST=central subfield thickness; ILM-RPE=inner limiting membrane-retinal pigment epithelium; ITT=intent to treat; nAMD=neovascular age-related macular degeneration; Q8W=every 8 weeks; Q16W=every 16 weeks.

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) and Diabetic Macular Edema (DME). 

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 during the first year was 2% (25 out of 1,262) in patients treated with VABYSMO compared with 2% (14 out of 625) in patients treated with aflibercept.

Adverse Reactions

The most common adverse reaction (≥5%) reported in patients receiving VABYSMO was conjunctival hemorrhage (7%).

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.

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