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VABYSMO Is the First IVT Injection Approved for Q4W to Q16W Dosing Intervals1,3,4

4 monthly doses followed by Q4W-Q16W or 6 monthly loading doses followed by Q8W. See §2.3 of the Prescribing Information for more.

YOSEMITE and RHINE: 2 large, Phase 3, 2-year, randomized, double-masked multicenter, active-comparator-controlled studies1,10

Randomized, double-masked, multicenter, active-comparator-controlled studies (table)

A total of 1891 diabetic patients were enrolled in the 2 studies, with a total of 1262 patients treated with at least 1 dose of VABYSMO. Patient ages ranged from 24 to 91, with a mean of 62.2 years. The overall population included both anti-VEGF naïve patients (78%) and patients who had been previously treated with a VEGF inhibitor prior to study participation (22%).1

Dose adjustment criteria1,10,12

Dosing adjustment criteria (table)

The utility of these disease activity criteria to guide dosing intervals has not been established.

aAfter week 12, patients continued on Q4W until CST <325 μm was achieved.12
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.12

bRegardless of BCVA increase or decrease, intervals were maintained.

cUnless accompanied by ≥10-letter decrease from reference BCVA (then interval maintained).12

dUnless CST increased 10-20% and accompanied by BCVA improvement or decrease <5 letters (then interval maintained).12

eReference BCVA was defined as the mean of the 3 best scores obtained at any prior study drug dosing visit.12

BCVA=best corrected visual acuity; CST=central subfield thickness; DME=diabetic macular edema; IVT=intravitreal; OCT=optical coherence tomography; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks; R 1:1:1=one-to-one-to-one ratio; SD-OCT=spectral domain-optical coherence tomography; VEGF=vascular endothelial growth factor.

VABYSMO was studied in the first DME trials with protocol-driven, treat-and-extend* dosing vs aflibercept Q8W (FDA-approved dosing regimen)3,10

*VABYSMO adjustable dosing based on disease activity measurements. Patients in this arm could have received between 3 and 11 total injections through week 56.1

DME Data
Expert Review: VABYSMO in DME

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) and Diabetic Macular Edema (DME). 

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 during the first year was 2% (25 out of 1,262) in patients treated with VABYSMO compared with 2% (14 out of 625) in patients treated with aflibercept.

Adverse Reactions

The most common adverse reaction (≥5%) reported in patients receiving VABYSMO was conjunctival hemorrhage (7%).

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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