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Durability

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

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with up to 4 years of durability data

Only VABYSMO offers flexible 1–4 month dosing¹*

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

VABYSMO patients on each dosing interval through year 4^1,2,11

After 4 loading doses, VABYSMO patients has a median of 4 injections in year 1, 3 injections in year 2, and 8 injections over years 3 and 4

Assessment and Limitations
The proportion of patients on each dosing interval was a prespecified secondary endpoint.²

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.
RHONE-X (OLE) lacked a comparator arm and therefore no conclusion around efficacy can be established.

*In nAMD and DME after 4 or 6 monthly (DME only) loading doses. Monthly dosing for 6 months in RVO.^{1

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

‡}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

§}Median number of injections of all patients in RHONE-X (OLE). VABYSMO 6 mg Q8W to VABYSMO 6 mg Q4W–Q16W patients received 8 injections, VABYSMO 6 mg Q4W–Q16W to VABYSMO 6 mg Q4W–Q16W patients received 7 injections, and aflibercept 2 mg Q8W to VABYSMO 6 mg Q4W–Q16W patients received 8 injections in RHONE-X (OLE).¹¹^¶Subgroup analysis of patients who had not discontinued the study at year 4. Treatment interval was defined as the decision followed within the last visit window for year 4 (weeks 192 to 204).¹¹

VABYSMO extended dosing intervals were achieved with control of CST and visual acuity^1,2,17

Patient case: Extension to Q16W maintained through 2 years¹⁷

Baseline
(week 0)

After loading phase (week 12)

Q16W decision (week 32)

Q16W at year 1 (week 96)

Snellen ~20/80 CST 489 μm

Snellen ~20/25 CST 304 μm

Snellen ~20/30 CST 280 μm

Snellen ~20/25 CST 274 μm

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.

Find out what flexible dosing can mean for your nAMD patients

nAMD Durability

DOSING & ADMINISTRATION

Find out how you can deliver flexible 1–4 month dosing

WHEN DOSING NEEDS CHANGE,
ACCESS DOESN’T HAVE TO

Explore how VABYSMO’s flexible dosing can help with payer access

BCVA=best corrected visual acuity; CST=central subfield thickness; DME=diabetic macular edema; nAMD=neovascular age-related macular degeneration; OLE=open-label extension; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks.

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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.

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