FDA Accepts Application for Roche’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)
Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). The sBLA is based on results from the phase III BALATON and COMINO studies that demonstrated treatment with Vabysmo provided early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. Vabysmo’s safety profile was consistent with previous trials.
“This acceptance brings us one step closer to delivering Vabysmo as a treatment for retinal vein occlusion, a disease that affects more than one million people in the United States and can cause severe and sudden vision loss,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “If approved, this would be the third indication for Vabysmo, the first bispecific antibody available for the treatment of retinal conditions that can cause blindness.”
The data from the BALATON and COMINO studies will be submitted to other health authorities around the world, including the European Medicines Agency, for approval for the treatment of macular edema following RVO. The studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every four months.
Vabysmo is the first bispecific antibody approved for the eye and was approved in the United States for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME) in January 2022. Vabysmo has also been approved in 60 countries around the world, including Japan, the United Kingdom and in the European Union for people living with nAMD and DME. Neovascular AMD, DME and RVO together affect around 70 million people worldwide and are among the leading causes of vision loss.
Vabysmo’s efficacy and safety profile in nAMD and DME is supported by four large, global studies involving more than 3,000 participants and extensive real-world experience, with nearly one million Vabysmo doses distributed globally. 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).
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