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Study Design in DME

START FIRST WITH VABYSMO

Studied head-to-head vs aflibercept 2 mg over 2 years in the largest Phase 3 trials in DME^1,15

1,891 DME patients were randomized to receive aflibercept 2 mg Q8W, VABYSMO Q8W or VABYSMO with variable (Q4W, Q8W, Q12W or Q16W) dosing in YOSEMITE & RHINE

VABYSMO’s treat-and-extend protocol did not mandate waiting for vision loss before intervening. Dosing intervals were driven primarily by changes on OCT^1,2,15

Intervals were based on the following criteria:^1,2,15*

Dosing intervals in DME were driven primarily by changes on OCT

*After week 12, patients continued on Q4W until CST <325 μm was achieved. Reference CST was defined as the CST value when the original reference value (CST <325 μm on Spectralis SD-OCT, <315 μm on Cirrus SD-OCT or Topcon SD-OCT) was met. Reference CST was adjusted if CST decreased by >10% from the previous reference CST for 2 consecutive study drug dosing visits and the values obtained were within 30 μm. The CST value obtained at the latter visit served as the new reference CST.^1

†Regardless of BCVA increase or decrease, intervals were maintained.^1

‡Unless accompanied by ≥10-letter decrease from reference BCVA (then interval maintained).^1

§Unless CST increased 10-20% and accompanied by BCVA improvement or decrease <5 letters (then interval maintained).^1

¶Reference BCVA was defined as the mean of the 3 best scores obtained at any prior study drug dosing visit.¹

BCVA=best corrected visual acuity; CST=central subfield thickness; DME=diabetic macular edema; OCT=optical coherence tomography; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks; SD-OCT=spectral domain-optical coherence tomograph.

DOSING & ADMINISTRATION

Find out how to deliver flexible 1–4 month dosing¹

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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  VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2024.
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