Swiss pharmaceutical company Roche has secured the US Food and Drug Administration (FDA) approval for Vabysmo (faricimab) to treat three primary causes of vision loss.
Vabysmo is a bispecific antibody that targets and inhibits two signalling pathways linked to several vision-threatening retinal conditions.
It works by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), which contribute to vision loss by destabilising blood vessels.
Vabysmo 6.0mg in a single-dose prefilled syringe (PFS) is indicated for the treatment of neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DME) and macular oedema following retinal vein occlusion (RVO).
The drug is already approved in over 95 countries worldwide, including the US, Japan, the UK and the European Union (EU) for people living with nAMD and DME.
It is the first and only bispecific antibody approved for the eye and has shown rapid and superior vision improvements and retinal drying in nAMD, DME and RVO, said the Swiss drugmaker.
Roche chief medical officer and global product development head Levi Garraway said: “We are pleased that the US FDA has approved the Vabysmo PFS for people living with neovascular age-related macular degeneration, diabetic macular oedema and retinal vein occlusion.
“While many retina specialists are already using Vabysmo as a first-line treatment, this new offering should make it even simpler to administer, thereby enhancing the treatment experience for both physicians and patients.”
Vabysmo PFS delivers the same medicine as the currently available Vabysmo vials in an alternative, ready-to-use format. Vabysmo will continue to be available in a 6.0 mg vial.
In a separate development, Roche has unveiled its plans to halt the Phase 2/3 SKYSCRAPER-06 study in non-small cell lung cancer (NSCLC) due to reduced efficacy in the interim analysis.
The Phase 2/3 study evaluated tiragolumab plus Tecentriq (atezolizumab) and chemotherapy compared to pembrolizumab and chemotherapy for the initial treatment of locally advanced unresectable or metastatic NSCLC.
The study did not meet its primary endpoints of progression-free survival (PFS) with a hazard ratio (HR) of 1.27 and overall survival (OS) with HR of 1.33, which was immature.
The Tecentriq combination showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, said the Swiss pharmaceutical firm.
