In what is expected to be great news for about 20,000 Australians, ophthalmologists are now able to prescribe the first and only bispecific antibody to treat macular oedema secondary to retinal vein occlusion through the Pharmaceutical Benefits Scheme (PBS).
From 1 March 2025, Vabysmo (faricimab), available as a 120 mg/mL solution for injection vial, is PBS listed for Aussies with macular oedema secondary to retinal vein occlusion (RVO), where a blockage in a retinal vein leads to fluid build-up in the macula.
Dr Hemal Mehta, a Sydney ophthalmologist involved in clinical trials with Vabysmo, welcomed the new subsidy, “at a time when rates of retinal and macular disease are on the rise”.
In a media release on the PBS listing, Dr Mehta said “as a bispecific antibody, Vabysmo acts on two distinct pathways to treat RVO.”
Vabysmo works by recognising and blocking the activity of two proteins, known as angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A), to help restore blood vessel stability and can lead to reduced fluid in the eye.
When these proteins are present at higher levels than normal, they can cause fluid leakage within the eye, which can negatively affect vision.
“Ophthalmologists can now prescribe Vabysmo through the PBS for RVO, as well as neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DMO),” Dr Mehta said.
The release said that results from the COMINO and BALATON Phase III studies showed that Vabysmo delivered sustained visual acuity gains comparable to aflibercept 2mg (an average of 17 ETDRS letters) to 24 weeks.
Thereafter, from weeks 24 to 72, all patients received Vabysmo 6mg treatment on an adjustable dosing regimen. More than 57% of patients in the BALATON study and 45% of patients in the COMINO study achieved extended treatment intervals of 12 weeks or more while maintaining the vision gains achieved in the first 24 weeks of treatment.
In both studies, the safety of Vabysmo in the treatment of RVO was consistent with the known safety profile of the medicine.
“With Vabysmo, we can treat many patients with macular oedema secondary to RVO with injection intervals of up to 16 weeks,” said Dr Mehta.
In Australia, the recommended dose of Vabysmo for RVO is 6mg monthly injections for a minimum of three months as treatment is initiated, with the frequency of subsequent injections determined by the ophthalmologist.
Treatment intervals longer than 16 weeks between injections have not been studied.
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