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For Patients and Caregivers

Drying in DME

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

Please see additional information on the Vision page

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 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 (post hoc analysis)

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.

What are experts saying about VABYSMO’s drying?

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’s membrane; IRF=intraretinal fluid; Q4W=every 4 weeks; Q8W=every 8 weeks; Q16W=every 16 weeks.

DRYING.
THERE’S MORE TO EXPLORE.

Discover the VABYSMO drying data across all 3 indications

Explore all the data
NEXT: Durability

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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