Biotechnology company Genentech, part of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY) announced on Friday that it has received US Food and Drug Administration (FDA) approval for Vabysmo (faricimab-svoa) as a treatment for macular edema following retinal vein occlusion (RVO).

This is the third approved indication for Vabysmo, in addition to wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME), collectively impacting approximately 3 million individuals in the US and contributing to significant vision loss.

RVO is the second most common cause of vision loss attributed to retinal vascular conditions, typically resulting in sudden, painless vision loss due to blocked retinal veins. Macular edema is a common consequence of RVO and is traditionally managed through repeated intravitreal injections of anti-vascular endothelial growth factor therapies.

Notably, Vabysmo is the first and only bispecific antibody approved for the eye. The FDA's decision was based on positive results from two global Phase III studies which demonstrated that monthly Vabysmo treatment delivers early and sustained vision enhancement in branch and central RVO cases, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. Furthermore, Vabysmo demonstrated effective drying of retinal fluid. Vabysmo was generally well tolerated and the safety profile was consistent with previous trials.

The US label now incorporates information in the Warnings & Precautions section regarding rare post-marketing instances of retinal vasculitis and vascular occlusion, primarily associated with intraocular inflammation. The reported rate of retinal vasculitis with vascular occlusion is 0.06 per 10,000 injections, in line with real-world reported frequencies of other widely used intravitreal treatments for wet AMD, DME and RVO.

Vabysmo has already received approval in over 80 countries worldwide for the treatment of wet AMD and DME, with approximately 2 million doses distributed globally.