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Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Diabetic Macular Edema (DME)
Macular Edema following Retinal Vein Occlusion (RVO)

DRYING.
THERE’S MORE TO EXPLORE.

START FIRST WITH DUAL-PATHWAY VABYSMO® (faricimab-svoa)

VABYSMO met its primary endpoint of non-inferiority vs aflibercept 2 mg in the mean change from baseline in BCVA in nAMD, DME, and RVO1

Primary endpoint was measured by the ETDRS letter score and tested for non-inferiority using a margin of 4 letters at year 1 in nAMD (avg. of weeks 40, 44, and 48), year 1 in DME (avg. of weeks 48, 52, and 56) and week 24 in RVO.1

Please see the Vision pages for more information:

Vision in nAMD       Vision in DME         Vision in RVO

Vision in nAMD    Vision in DME    Vision in RVO

Drying is a key factor when choosing a first-line treatment

Explore rapid & sustained drying across all 3 indications2-4

nAMD

Greater CST reductions vs aflibercept 2 mg

in the matched dose phase2

Rapid and sustained CST reductions (secondary endpoint)1,2
Mean change in CST from baseline through week 48 in nAMD

Assessment and Limitations
Reduction in CST (ILM-RPE) over time was a prespecified secondary endpoint.2

  • 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.

*After 4 monthly loading doses.1 See additional dosing interval information on the nAMD Durability page.

Greater retinal drying vs aflibercept 2 mg

in the matched dose phase2

Rapid and sustained resolution of IRF & SRF (secondary endpoint)2
Resolution of IRF & SRF in nAMD

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.2

  • 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.

DME

Greater CST reductions vs aflibercept 2 mg

in the matched dose phase, at year 1, and at year 22,3,16

Rapid and sustained CST reductions (secondary endpoint)2,3,16
Mean change in CST from baseline through week 100 in DME

Assessment and Limitations
Reduction in CST (ILM-BM) over time was a prespecified secondary endpoint.2

  •  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.

†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).1,2 See additional dosing interval information on the DME Durability page.

Greater retinal drying vs aflibercept 2 mg

in the matched dose phase, at year 1, and at year 23

Rapid and sustained resolution of IRF (secondary endpoint)2,3
Resolution of IRF in DME

Assessment and Limitations
Retinal drying is defined as absence of IRF. Absence of IRF was a prespecified secondary endpoint.2

  • 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.

First time to an IRF-free retina3

Time to first absence of IRF (post hoc analysis)3
Time to first 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.

Resolution of macular leakage17  

Beyond the OCT: Absence of macular leakage as a marker of drying17

Fluorescein angiographic images of a DME patient17
Fluorescein angiographic images of a DME patient

Macular leakage was assessed by the reading center based on fluorescein angiographic images. Resolution was defined as a leakage area of ≤1 mm2 within an ETDRS grid.17

Individual results may vary.
No serious ocular adverse drug reactions were observed/reported in the treated eye.

Resolution of macular leakage at week 16 (post hoc analysis)17‡
Resolution of macular leakage at week 16 in DME

Limitations of Analysis
This is a post hoc analysis and was not prespecified.

  • The statistical significance of these results cannot be determined and the clinical significance of these results is unknown.

‡Fundus fluorescein angiographic images were collected and assessed at baseline, week 16, year 1, and early termination visits. This analysis only includes study patients with evaluable fluorescein angiography data at week 16.

RVO

Rapid and sustained CST reductions

maintained to week 722,12

Mean change in CST from baseline (secondary endpoint)2,12

Mean change in CST from baseline to week 72 in BRVO

Assessment and Limitations
Reduction in CST (ILM-BM) over time was a prespecified secondary endpoint.2

  • Clinical significance has not been established, and conclusions regarding treatment effects cannot be drawn.
  • The OLE lacked a comparator arm and therefore no conclusion around efficacy can be established.
  • The variable dosing in the OLE is not an approved dosing regimen. Approved dosing is 6 mg Q4W for 6 months.1
Mean change in CST from baseline to week 72 in CRVO

Resolution of macular leakage4,17

Beyond the OCT: Absence of macular leakage as a marker of drying17

Fluorescein angiographic images of an RVO patient treated with VABYSMO17
Fluorescein angiographic images of an RVO patient treated with VABYSMO

Macular leakage was assessed by the reading center based on fluorescein angiographic images. Resolution was defined as a leakage area of 0 mm2 within an ETDRS grid.17

Individual results may vary.
No serious ocular adverse drug reactions were observed/reported in the treated eye.

Resolution of macular leakage at week 24 (prespecified exploratory endpoint)2,4,17§
Resolution of macular leakage at week 24 in RVO

Assessment and Limitations
Resolution of macular leakage was a prespecified exploratory endpoint.2

  • The statistical significance of these results cannot be determined and the clinical significance of these results is unknown.

§Fundus fluorescein angiographic images were collected and assessed at baseline and predefined follow-up intervals. This analysis only included study patients with evaluable fluorescein angiography data.

And with VABYSMO, drying is a key driver of durability1,2

Discover the power of flexible 1–4 month dosing1#

In Phase 3 trials for nAMD and DME, VABYSMO’s dosing intervals could be driven by changes on OCT alone, without the need for vision loss.1,2
#In nAMD and DME after 4 or 6 monthly (DME only) loading doses. Monthly dosing for 6 months in RVO.1 See additional dosing information on the nAMD, DME, and RVO Dosing and Administration pages.

Durability in nAMD
Durability in DME

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; ILM-BM=inner limiting membrane-Bruch’s membrane; ILM-RPE=inner limiting membrane-retinal pigment epithelium; IRF=intraretinal fluid; LS=least squares; nAMD=neovascular age-related macular degeneration; OCT=optical coherence tomography; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks; RVO=retinal vein occlusion; SRF=subretinal fluid.

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), 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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