Industry News
Vabysmo Becomes First Bispecific Antibody Listed on PBS for Retinal Vein Occlusion
Australian ophthalmologists now have access to the first and only bispecific antibody for treating macular oedema secondary to retinal vein occlusion (RVO) through the Pharmaceutical Benefits Scheme (PBS).
From 1 March 2025, Roche’s Vabysmo® (faricimab) will be available on the PBS, providing treatment for an estimated 20,000 Australians affected by RVO, a condition where a blockage in the retinal vein leads to fluid accumulation in the macula. Roche is a global leader in biotechnology and in-vitro diagnostics, committed to scientific excellence and personalised healthcare.
Dr Hemal Mehta, a Sydney-based ophthalmologist involved in Vabysmo’s clinical trials, welcomed the PBS listing at a time when retinal and macular disease rates are increasing. “Vabysmo is a bispecific antibody that targets two key pathways involved in RVO, helping to restore blood vessel stability and reduce fluid in the eye,” Dr Mehta explained.
Vabysmo works by inhibiting angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A), two proteins that, when present in high levels, contribute to fluid leakage and vision impairment. The medication is already PBS-listed for neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DMO).
Clinical Evidence and Treatment Benefits
Results from the Phase III COMINO and BALATON studies demonstrated that Vabysmo provides sustained visual acuity improvements comparable to aflibercept 2mg, with patients gaining an average of 17 ETDRS letters over 24 weeks. Beyond this period, 57% of BALATON study participants and 45% from the COMINO study achieved extended treatment intervals of 12 weeks or longer while maintaining vision gains.
“In Australia, the recommended Vabysmo dose for RVO is 6mg monthly injections for at least three months, with further dosing determined by the treating ophthalmologist. Some patients may benefit from injection intervals extending up to 16 weeks,” said Dr Mehta.
Roche’s Commitment to Advancing Eye Care
Dr Nic Horridge, General Manager of Roche Pharmaceuticals Australia, praised the Federal Government’s investment in ophthalmic care. “Roche is committed to setting new standards in eye care for Australians. We are proud to improve access to this first-of-its-kind treatment through the PBS,” he said.
This listing marks Roche’s continued expansion in ophthalmology, following the 2023 PBS reimbursement of Vabysmo for nAMD and DMO. “We are dedicated to innovation and improving outcomes for patients with vision-threatening diseases,” Dr Horridge added.
