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Real-World Evidence

FARETINA: The largest real-world DME study of VABYSMO¹⁸

Real-world outcomes reported in the IRIS^® registry from the American Academy of Ophthalmology¹⁸

VABYSMO has 2 years of real-world evidence in the subset analysis patient population¹⁸*

*Analysis includes patients with documented diagnosis for DME and known laterality, record of first VABYSMO injection between February 7, 2022 – March 31, 2023, ≥12 months of medical data before VABYSMO initiation, ≥24 months of follow-up medical data, ≥2 VA measures on or after the first VABYSMO injection and adherence to the loading dosing regimen consistent with label (x4 loading doses).¹⁸
^†Defined as no anti-VEGF ≥12 months prior to VABYSMO initiation.¹⁸

Visual acuity and mean injections observed over 2 years in treatment-naive eyes^18‡

FARETINA-DME

FARETINA-DME

FARETINA-DME

In the pivotal Phase 3 clinical trials, YOSEMITE & RHINE, the mean number of VABYSMO injections was ~9 in year 1 (through week 56) and ~4 in year 2 (weeks 60–96).¹⁹

Limitations of Analysis

Limited to EHR data captured in routine practice.
Patients switching or discontinuing VABYSMO treatment prior to 24 months are not reflected in this analysis.
No standardized measurements or physician dosing frequency rationale.
Current data do not necessarily reflect future treatment patterns.
This is a purely descriptive study with no statistical testing or P values reported.

^‡Among eyes with VA at baseline and at 24 months from the subset analysis.¹⁸

Visual acuity and mean injections observed over 2 years in previously-treated eyes^18‡

FARETINA-DME

FARETINA-DME

FARETINA

FARETINA-DME

Limitations of Analysis

Limited to EHR data captured in routine practice.
Patients switching or discontinuing VABYSMO treatment prior to 24 months are not reflected in this analysis.
No standardized measurements or physician dosing frequency rationale.
Current data do not necessarily reflect future treatment patterns.
This is a purely descriptive study with no statistical testing or P values reported.

^‡Among eyes with VA at baseline and at 24 months from the subset analysis.¹⁸

Functional vision (20/40 or better) observed in >60% of eyes at year 2¹⁸

Proportion of eyes with 20/40 or better VA at baseline and year 2¹⁸

FARETINA-DME

FARETINA-DME

FARETINA-DME

Limitations of Analysis

Limited to EHR data captured in routine practice.
Patients switching or discontinuing VABYSMO treatment prior to 24 months are not reflected in this analysis.
No standardized measurements or physician dosing frequency rationale.
Current data do not necessarily reflect future treatment patterns.
This is a purely descriptive study with no statistical testing or P values reported.

^‡Among eyes with VA at baseline and at 24 months from the subset analysis.¹⁸

Low rates of endophthalmitis and rates of intraocular inflammation over 2 years, similar to clinical trials¹⁸

Percentage of events per injection in the subset analysis population¹⁸

Limitations of Analysis

Limited to EHR data captured in routine practice.
Patients switching or discontinuing VABYSMO treatment prior to 24 months are not reflected in this analysis.
No standardized measurements or physician dosing frequency rationale.
Current data do not necessarily reflect future treatment patterns.
This is a purely descriptive study with no statistical testing or P values reported.

^§Among 589 DME patients and approximately 12,438 injections meeting the inclusion & exclusion criteria of the FARETINA DME subset analysis. First diagnosis of endophthalmitis, iridocyclitis, iritis, uveitis, and vitritis in the IRIS Registry EHR following VABYSMO initiation with no diagnoses at least 12 months prior.¹⁸

DME=diabetic macular edema; EHR=electronic health records; ETDRS=Early Treatment Diabetic Retinopathy Study; FDA=US Food and Drug Administration; IRIS=Intelligent Research in Sight; VA=visual acuity; VEGF=vascular endothelial growth factor.

PEER PERSPECTIVES

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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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