VABYSMO

What it is

Vabysmo contains faricimab, a humanised bispecific immunoglobulin G1 antibody supplied as a solution for injection at a concentration of 120 mg/mL. It is presented as a solution for injection for intravitreal use. Faricimab acts through inhibition of two distinct pathways by neutralisation of both angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A).

Approved indications Vabysmo is indicated for the treatment of:

— Neovascular (wet) age-related macular degeneration (nAMD) — Diabetic macular oedema (DMO) — Macular oedema secondary to retinal vein occlusion (RVO)

Dosing overview

Vabysmo is for intravitreal injection only and must be administered by a qualified ophthalmologist experienced in intravitreal injections. Dosing varies by indication:

No dose modifications of Vabysmo are recommended.

Key safety warnings

Intravitreal injections, including those with Vabysmo, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract. Proper aseptic injection techniques must always be used when administering Vabysmo. Retinal vasculitis and/or retinal occlusive vasculitis have been reported with the use of Vabysmo in the postmarketing setting. Treatment should be discontinued in patients who develop these events. Transient increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including those with Vabysmo. Special precaution is needed in patients with poorly controlled glaucoma (do not inject Vabysmo while the intraocular pressure is ≥ 30 mmHg). Systemic adverse events including arterial thromboembolic events, such as stroke and myocardial infarction, have been reported following intravitreal injection of vascular endothelial growth factor inhibitors and there is a theoretical risk that these may be related to VEGF inhibition.

Contraindications

Vabysmo is contraindicated in patients with a known hypersensitivity to faricimab or any of the excipients, ocular or periocular infections, or active intraocular inflammation.

PBS listing

Vabysmo is listed on the PBS in two presentations: 21 mg in 0.175 mL pre-filled syringe and 28.8 mg in 0.24 mL vial, both at 120 mg per mL concentration. Both presentations have 6 PBS items with streamlined and authority required restrictions, with an ex-manufacturer price of A$827.40.

Regulatory history

Vabysmo was first registered on the ARTG on 8 August 2022 as a solution for injection vial. A pre-filled syringe formulation was subsequently registered on 30 September 2024. In May 2022, the PBAC recommended Vabysmo for nAMD with Authority Required listing, with non-inferior comparative effectiveness and safety to aflibercept accepted and cost-effectiveness acceptable if cost-minimised to PBS-listed anti-VEGF treatments. In the same meeting, the PBAC recommended Vabysmo for DMO with Authority Required listing, with non-inferior comparative effectiveness and safety to aflibercept accepted. In July 2024, the PBAC recommended Vabysmo for retinal vein occlusion, with a further recommendation in March 2025 for the new formulation for macular oedema secondary to retinal vein occlusion.