Roche’s Vabysmo Rapidly Improved Vision and Reduced Retinal Fluid in People with Retinal Vein Occlusion (RVO)
Roche today announced positive new data from two global phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab) in macular edema due to branch and central Retinal Vein Occlusion (RVO) at 24 weeks. The studies showed that treatment with Vabysmo resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to treatment with aflibercept. Vabysmo also showed rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness. The safety profile of Vabysmo was consistent with previous trials. Results will be presented virtually on 11 February at Angiogenesis, Exudation and Degeneration 2023, organised by the Bascom Palmer Eye Institute in Florida, United States.
“These encouraging results reinforce the potential of Vabysmo as a new treatment option for people experiencing vision loss associated with retinal vein occlusion (RVO),” said Levi Garraway, M.D., Ph.D., Roche Chief Medical Officer and Head of Global Product Development. “As these positive data continue to accrue, we believe Vabysmo may redefine the standard of care for multiple types of retinal conditions that can cause blindness.”
Neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and RVO together affect around 70 million people worldwide and are among the leading causes of vision loss. Data from the BALATON and COMINO studies will be submitted to health authorities around the world, including the United States Food and Drug Administration and European Medicines Agency, for approval for the treatment of macular edema due to RVO. If approved, this would be the third indication for Vabysmo, which is currently approved in more than 50 countries to treat nAMD and DME.
“Retinal vein occlusion can cause fluid to become trapped within and under the retina, leading to rapid and severe vision loss if left untreated,” said Ramin Tadayoni, M.D., Ph.D., president-elect of EURETINA, who is presenting the data at Angiogenesis. “These promising results show that Vabysmo effectively reduces fluid in the retina and improves vision in patients with retinal vein occlusion.”
Vabysmo’s efficacy and safety in nAMD and DME have been demonstrated by two-year data from four large, global studies involving more than 3,000 participants. Vabysmo is the first bispecific antibody approved for the eye with phase III studies supporting treatment intervals of up to four months for people with these conditions. It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Globally, more than 450,000 Vabysmo doses have been distributed for treatment of these conditions to date.
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