Roche gets FDA nod for Vabysmo in retinal vein occlusion

Oct. 30, 2023

Late last week, Roche announced that the U.S. FDA approved Vabysmo for the treatment of macular edema following retinal vein occlusion (RVO) — the third indication for the bispecific antibody.

The approval in RVO is based on positive results from the global phase 3 BALATON and COMINO studies that demonstrated monthly treatment with Vabysmo provided early and sustained improvement in vision in people with branch and central RVO, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept.

RVO typically results in sudden, painless vision loss in the affected eye because the vein blockage restricts normal blood flow in the affected retina, resulting in ischaemia, bleeding, fluid leakage and retinal swelling, called macular edema. 

“Vabysmo is a new treatment option for RVO that can help people preserve and improve their vision, with the added benefit of retinal drying,” said Levi Garraway, Roche’s chief medical officer and head of Global Product Development. 

Vabysmo became the first FDA-approved bispecific antibody treatment for the eye when it was granted approval for two leading causes of vision loss — wet age-related macular degeneration (AMD) and diabetic macular edema (DME) back in January 2022.

Now with the approval in RVO, the injectable drug can treat the three retinal conditions that affect around 70 million people worldwide and are among the leading causes of vision loss.