Vabysmo (faricimab, Roche), has been listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of approximately 20,000 Australians living with macular oedema secondary to retinal vein occlusion (RVO), where a blockage in a retinal vein leads to fluid build-up in the macula.1,2
Available as a 120 mg/mL solution for injection vial, this is the first and only PBS-listed bispecific antibody* for macular oedema secondary to RVO.1,3
The PBS listing is effective 1 March 2025.
this is the first and only PBS-listed bispecific antibody* for macular oedema secondary to RVO
Welcomed Subsidy
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”.4
“As a bispecific antibody,* Vabysmo acts on two distinct pathways** to treat RVO,”3 he explained.
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.**3 When these proteins are present at higher levels than normal, they can cause fluid leakage within the eye, which can negatively affect vision.3
“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),”1,3 Dr Mehta said.
Sustained Visual Acuity Gains
Results from the COMINO and BALATON Phase III studies showed that Vabysmo delivers sustained visual acuity gains comparable to aflibercept 2 mg (an average of 17 ETDRS letters) to 24 weeks.5,6
Thereafter, from weeks 24 to 72, all patients received Vabysmo 6 mg 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.2,7
In both studies, the safety of Vabysmo in the treatment of RVO was consistent with the known safety profile of the medicine.*** 5,6
“With Vabysmo, we can treat many patients with macular oedema secondary to RVO with injection intervals of up to 16 weeks,”3 said Dr Mehta.
In Australia, the recommended dose of Vabysmo for RVO is 6 mg 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.3
Investment in Ophthalmic Care
Dr Nic Horridge, General Manager, Roche Pharmaceuticals Australia, commended the Federal Government for recognising the value of Vabysmo for macular oedema secondary to RVO.
“We are pleased to play our part in providing affordable access to this first-of-its kind* medicine for Australians impacted by RVO,” said Dr Horridge.
“It was only two years ago that we introduced our first ophthalmic therapy with the PBS listing of Vabysmo for wet age-related macular degeneration and diabetic macular oedema. We continue to innovate and are pleased to have secured the reimbursement of Vabysmo for macular oedema following RVO,” he said.
*Vabysmo is a first-of-its-kind bispecific antibody treatment for the eye, which means that it is designed to inhibit two distinct pathways that contribute to macular oedema secondary to retinal vein occlusion (RVO).3 By working on these two pathways, Vabysmo can block their actions and may improve disease and/or slow down worsening of the disease, thereby maintaining a patient’s vision.8
** Preclinical data does not necessarily predict clinical effect
*** All medicines have side effects. Common adverse events reported with Vabysmo were cataract (12.7%), conjunctival haemorrhage (8.0%), vitreous detachment (4.8%), intraocular pressure increased (4.2%), vitreous floaters (4.1%), eye pain (3.0%), retinal pigment epithelial tear (nAMD only)(2.9%), lacrimation increased (1.1%), corneal abrasion (1.1%), eye irritation (1.1%). The most serious adverse reactions were uveitis (0.6%), endophthalmitis (0.5%), vitritis (0.3%), retinal tear (0.2%), rhegmatogenous retinal detachment (0.1%) and traumatic cataract ((<0.1%). Please refer to the Vabysmo Product Information for further safety information.3
References
1. Australian Government Department of Health and Aged Care. Pharmaceutical Benefits Scheme. February 2025.
2. Roche Australia. Data on file – RVO patients eligible for PBS subsidy. 2025
3. VABYSMO product information. September 2024.
4. Song P, Xu Y, Zha M, Zhang Y, Rudan I. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019 Jun;9(1):010427. doi: 10.7189/jogh.09.010427.
5. Tadayoni R et al. Efficacy and safety of faricimab for macular edema due to retinal vein occlusion 24-week results from the BALATON and COMINO trials. Ophthalmology 2024;131(8):950–960 doi10.1016/j.ophtha.2024.01.029
6. Hattenbach LO et al. Ophthalmol Sci 2023;3(3):100302.
7. Tadayoni R et al. Presentation at the Angiogenesis, exudation, and degeneration virtual congress, February 3, 2024.
