Roche Secures US FDA Nod For Vabysmo Prefilled Syringe

Roche, a leading pharmaceutical firm, declared the United States Food and Drug Administration (US FDA) has sanctioned the Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). With each other, all these three conditions affect around 80 million people across the globe. The Vabysmo PFS will become ready to United States (US) retina specialists and their patients in the upcoming months.

“We are pleased that the US FDA has approved the Vabysmo PFS for people living with neovascular age-related macular degeneration, diabetic macular edema and retinal vein occlusion, which are some of the leading causes of vision loss,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development. “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.”

In a different, ready-to-use form, Vabysmo PFS offers the similar medication as Vabysmo vials presently on the market. Vabysmo will keep on being accessible in a 6.0 mg vial.

In nAMD, DME, and RVO, Vabysmo has showcased quick and robust vision improvements as well as retinal drying. It is the first and only bispecific antibody approved for the eye. Retinal drying is an vital clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.