The US Food and Drug Administration (FDA) has granted approval for Roche’s Vabysmo (faricimab) to treat macular oedema following retinal vein occlusion (RVO). 

The latest approval is based on positive data from the global Phase III BALATON and COMINO clinical trials of Vabysmo.

Data from these studies showed that Vabysmo administered monthly offered quick and continued vision improvement in branch and central RVO patients. 

The trials also met the primary endpoint of non-inferior visual acuity gains at 24 weeks versus aflibercept. The treatment also offered retinal fluid drying in these patients.

In both trials, Vabysmo was found to be well tolerated with a safety profile in line with prior studies. 

Vabysmo is a bispecific antibody currently approved in more than 80 countries.

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It is also indicated to treat neovascular or “wet” age-related macular degeneration and diabetic macular oedema.

Roche Global Product Development head and chief medical officer Levi Garraway said: “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.”

In October 2023, Roche posted a 7% rise in group sales to SFr14.27bn ($15.91bn) at constant exchange rates in the third quarter of 2023.