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VISION GAINS
ANATOMICAL OUTCOMES
TREATMENT INTERVALS

VISION GAINS

VABYSMO Delivers Powerful First-Line Efficacy With Extended Dosing Intervals Over 2 Years1,15

VABYSMO met its primary endpoint of non-inferiority vs aflibercept 2 mg Q8W (avg. of weeks 48, 52, and 56)1

Mean change in BCVA vs aflibercept 2 mg from baseline to week 1001,15

Mean change in BCVA from baseline to week 56 in DME (chart)

VABYSMO met its primary endpoint of non-inferiority vs aflibercept 2 mg in the mean change from baseline in BCVA at year 1 (avg. of weeks 48, 52, and 56).1

Primary endpoint was measured by the ETDRS letter score and tested for non-inferiority using a margin of 4 letters. 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 2.1

*After 4 monthly loading doses, patients in the VABYSMO Q4W-Q16W arm received a median of 7 injections over 2 years (max of 21), with a median of 3 in year 2 (max of 10).1,6

ANATOMICAL OUTCOMES

Greater CST Reductions vs aflibercept 2 mg

in the matched dose phase, at year 1, and at year 26,15,16

Rapid and sustained CST reductions (secondary endpoint)1,6,15

Changes in CST from baseline through week 56 in DME (chart)

Assessment and Limitations:

Reduction in CST (ILM-BM) over time was 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, patients in the VABYSMO Q4W-Q16W arm received a median of 7 injections over 2 years (max of 21), with a median of 3 in year 2 (max of 10).1,6

Greater Retinal Drying vs aflibercept 2 mg

in the matched dose phase, at year 1, and at year 215

Rapid and sustained resolution of IRF (secondary endpoint)6,15

Percentage patients with absence of IRF in DME (chart)

Assessment and Limitations:

Retinal drying is defined as absence of IRF. Absence of IRF was 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

First Time to an IRF-Free Retina15

Time to first absence of IRF (post-hoc analysis)15

Percentage of patients with absence of IRF in DME (post hoc analysis)

Limitations of Analysis:

This is a post-hoc analysis and is not prespecified. The statistical significance of these results cannot be determined and the clinical significance of these results is unknown. The 50th percentile line describes the time point where absence of IRF was observed for 50% of patients in each treatment arm. No formal comparison can be made.

TREATMENT INTERVALS

Start With the Power of 1–4 Month Dosing1

VABYSMO can be administered via one of two regimens:1

  • ≥4 monthly loading doses‡ → Q4W–Q16W§
  • 6 monthly loading dose‡ → Q8W

‡Although VABYSMO may need to be dosed as frequently as every 4 weeks after the first 4 doses, additional efficacy was not demonstrated in most patients compared to every 8 weeks.1

§If resolution of fluid based on CST is achieved, the interval may be modified based on CST and visual acuity in ≤4-week increment extensions, or ≤8-week increment reductions.1

VABYSMO can be administered via one of two regimens:1

  • ≥4 monthly loading doses‡ → Q4W–Q16W§
  • 6 monthly loading dose‡ → Q8W

‡Although VABYSMO may need to be dosed as frequently as every 4 weeks after the first 4 doses, additional efficacy was not demonstrated in most patients compared to every 8 weeks.1

§If resolution of fluid based on CST is achieved, the interval may be modified based on CST and visual acuity in ≤4-week increment extensions, or ≤8-week increment reductions.1

After 4 loading doses, VABYSMO Q4W—Q16W patients received a median of 7 injections over 2 years (max of 21)1,6

At week 56, 32% had completed ≥1 Q12W & 1 Q16W interval; 17% were on Q8W and/or Q4W (7% only on Q4W).

Assessment and Limitations:

The proportion of patients on each dosing interval was a prespecified secondary endpoint. Not controlled for type 1 error, therefore, no formal conclusions can be drawn. Different inclusion/exclusion criteria and disease activity criteria may generate different results. The disease activity criteria utilized are not validated and the aflibercept arm was not dosed similarly.6

This range excludes patients that did not complete the full 2-year protocol. The range for all enrolled patients was 1–21 total injections.1,6

#At week 56, 32% completed one full Q16W interval.17% were treated on Q8W and/or Q4W (7% on Q4W only) through week 56.1

VABYSMO Extended Dosing Intervals Were Achieved With Control of CST and Visual Acuity1,16,17

Patient case: Extension to Q16W maintained through 2 years17

Baseline
(Week 0):
Snellen 20/80
CST 489 μm After Loading Phase
(Week 12):
Snellen 20/25
CST 304 μm Q16W Decision
(Week 32):
Snellen 20/30
CST 280 μm Q16W At 2 Years
(Week 96):
Snellen 20/25
CST 274 μm
Baseline CST response
Week 12 CST response
Week 32 CST response
Week 96 CST response

This patient was a participant with DME 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; DME=diabetic macular edema; ETDRS=Early Treatment Diabetic Retinopathy Study; ILM-BM=inner limiting membrane-Bruch membrane; IRF=intraretinal fluid; LS=least squares; OCT=optical coherence tomography; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks.

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

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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