Roche Announces U.S. FDA Acceptance of Supplemental Biologics Licence Application (sBLA) for Vabysmo® (faricimab)
Tuesday, May 09, 2023
Roche announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics Licence Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular oedema following retinal vein occlusion (RVO).
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 oedema (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.
This acceptance brings one step closer in 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. If approved, this can be the third indication for Vabysmo, the first bispecific antibody available for the treatment of retinal conditions that can cause blindness.
