Roche’s Vabysmo approved by FDA for retinal vein occlusion treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Vabysmo (farcimab) for the treatment of macular edema following retinal vein occlusion (RVO).
This approval marks the third indication for Vabysmo, following neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). These three conditions combined affect approximately 70 million people globally and are among the leading causes of vision loss.
The drug is the first and only bispecific antibody to be approved for treatment of the eye. The approval in RVO follows positive information from the global phase 3 BALATON and COMINO studies which demonstrated an early and sustained improvement in vision in patients with branch and central RVO.
The drug was generally well tolerated, with a consistent safety profile and the most common adverse reaction being conjunctival haemorrhage.
Levi Garraway, MD PhD, Roche’s chief medical officer and head of Global Product Development, commented: “Vabysmo is a new treatment option for RVO that can help people preserve and improve their vision, with the added benefit of retinal drying. The efficacy and safety profile of Vabysmo has been well established in global clinical trials and is reinforced by a growing breadth of real-world evidence, with hundreds of thousands of people treated.”
Orexo has announced that its New Drug Application (NDA) for OX124 has been accepted for …
Arcturus Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan …
Alladapt Immunotherapeutics has announced that ADP101 has received Fast Track Designation from the US Food …