Roche Australia has announced the Australian Therapeutic Goods Administration (TGA) has registered Vabysmo (faricimab) for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DMO).
Both eye conditions are leading causes of vision loss worldwide and present a growing health issue as populations age and experience increased prevalence of diabetes.
It is estimated that approximately 128,000–192,000 Australians are living with nAMD, and an estimated 40,000 Australians are impacted by DMO, according to Roche Australia.
Vabysmo – which has been recommended for PBS listing – is the first TGA-registered bispecific antibody approved for the eye in Australia. It specifically recognises and blocks the activity of proteins known as angiopoietin-2 and vascular endothelial growth factor A.
It joins an expanding list of approved anti-VEGF therapies for macular disease in Australia, which currently comprises Eylea (aflibercept), Lucentis (ranibizumab) and, more recently, Beovu (brolucizumab).
Roche said Vabysmo is administered by four initial four-weekly eye injections.
“Thereafter, the frequency of the ongoing injections will be determined by the treating physician and may be up to 16 weeks apart based on the patient’s anatomic and vision outcomes,” the biotech company said.
Professor Paul Mitchell, director of the Centre for Vision Research at the Westmead Institute for Medical Research, said both nAMD and DMO can have physical, emotional and economic consequences for patients and their families.
“As the conditions progress, people living with nAMD or DMO may become increasingly dependent on their loved ones for everyday activities as well as have their professional and social lives negatively affected,” he said.
Mr Richard Woodfield, country medical director at Roche Australia, said the company is delighted the TGA has registered Vabysmo for people living with either nAMD or DMO in Australia.
“This registration marks a significant step in our commitment to people living with retinal conditions and we will continue to work collaboratively with the government through the required next steps to ensure eligible Australians are able to access this additional treatment option as soon as possible,” Woodfield said.
Roche’s pharmaceutical division in Australia employs over 300 people. Australian patients have access to around 35 Roche medicines.
Building on its heritage of developing new medicines in oncology, immunology, infectious diseases, and neurology, Roche is now taking on the leading causes of blindness and visual impairment, addressing the critical needs of people living with debilitating eye diseases. The company said its investment in ophthalmology is centred on designing solutions tailored to the biology of the disease.
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