FDA Approves Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)

The FDA has approved Genentech's Vabysmo (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). The approval for RVO marks the third indication for Vabysmo, along with wet age-related macular degeneration (AMD) and diabetic macular edema (DME). 

Vabysmo is the first and only bispecific antibody approved for the eye. The approval in RVO is based on 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 noninferior visual acuity gains at 24 weeks compared to aflibercept. This was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluid.

In BALATON and COMINO, Vabysmo was generally well tolerated and the safety profile was consistent with previous trials. The most common adverse reaction was conjunctival hemorrhage (3%). Safety results were consistent across study arms. Information has been added to the 'Warnings & Precautions' section of the US label based on rare post-marketing cases of retinal vasculitis and/or retinal vascular occlusion, typically in the presence of 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 broadly used intravitreal treatments for people living with wet AMD, DME, and RVO, according to Genentech.

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

To date, Vabysmo is approved in more than 80 countries around the world for people living with wet AMD and DME, with approximately 2 million doses distributed globally.

Vabysmo targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels.