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VISION GAINS
ANATOMICAL OUTCOMES
TREATMENT INTERVALS

VISION GAINS

VABYSMO Delivers Powerful First-Line Efficacy With Extended Dosing Intervals1*

VABYSMO met its primary endpoint of non-inferiority vs aflibercept Q8W1*

Mean change in BCVA vs aflibercept from baseline to week 481,6

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

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. Mean change in BCVA was 5.8 letters (CI [95%]: 4.6, 7.1) for VABYSMO Q8W-Q16W and 5.1 letters (CI [95%]: 3.9, 6.4) for aflibercept Q8W in TENAYA; and 6.6 letters (CI [95%]: 5.3, 7.8) for VABYSMO Q8W-Q16W and 6.6 letters (CI: [95%] 5.3, 7.8) for aflibercept Q8W in LUCERNE.1

*After 4 monthly loading doses.1 See additional dosing interval information in the Treatment Interval section.

ANATOMICAL OUTCOMES

Greater CST Reductions vs aflibercept

in the matched dose phase6

Rapid and sustained CST reductions (secondary endpoint)1,6

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.6

†After 4 monthly loading doses.1 See additional dosing interval information in the Treatment Intervals section.

Greater Retinal Drying vs aflibercept

in the matched dose phase6

Rapid and sustained resolution of IRF & SRF (secondary endpoint)6

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

Assessment and Limitations:

Retinal drying is defined as absence of IRF and SRF. Absence of IRF or SRF, and absence of IRF and SRF were prespecified secondary endpoints. 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.6

TREATMENT INTERVALS

Start With the Power of 1–4 Month Dosing1

VABYSMO patients on each dosing interval at week 481‡

TENAYA and LUCERNE Pooled (n=664) 45% Q16W 33% Q12W 22% Q8W

Assessment and Limitations:

Percentages may not be generalizable to a broader nAMD population. Different inclusion/exclusion criteria and disease activity criteria may generate different results. Enrollment was limited to treatment-naive, newly diagnosed nAMD patients. The disease activity criteria utilized are not validated and the aflibercept arm was not dosed similarly, interpret percentages with caution.6

‡Q16W=weeks 28 and 44; Q12W=weeks 24, 36, and 48; Q8W=weeks 20, 28, 36, and 44.1

VABYSMO Extended Dosing Intervals Were Achieved With Control of CST and Visual Acuity1,6,13

Patient case: Achieved Q16W dosing13

Baseline
(Week 0):
Snellen 20/40
CST 430 μm After Loading Phase
(Week 16):
Snellen 20/20
CST 179 μm Q16W Decision
(Week 24):
Snellen 20/25
CST 187 μm Q16W At Year 1
(Week 56):
Snellen 20/20
CST 189 μm
Baseline CST response
Week 16 CST response
Week 24 CST response
Week 56 CST response

This patient was a participant with nAMD receiving VABYSMO in clinical trials. Individual results may vary.

No serious ocular adverse drug reactions were observed/reported in the treated eye.

BCVA=best corrected visual acuity; CST=central subfield thickness; ETDRS=Early Treatment Diabetic Retinopathy Study; ILM-RPE=inner limiting membrane-retinal pigment epithelium; IRF=intraretinal fluid; LS=least squares; nAMD=neovascular age-related macular degeneration; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks; SRF=subretinal fluid.

Look at VABYSMO's Safety Profile
Explore VABYSMO's Access Information
Watch Experts Discuss the nAMD Trials

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 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.

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.

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