FDA Approves Genentech’s Vabysmo for Treatment of RVO

The FDA has approved Genentech's Vabysmo (faricimab-svoa) for the treatment macular edema following retinal vein occlusion (RVO). This approval for RVO signifies the third recognized use for Vabysmo, alongside wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

Vabysmo stands as the initial and singular bispecific antibody sanctioned for ocular application. The endorsement in the case of RVO rests on findings derived from the international phase 3 BALATON and COMINO studies, which demonstrated that monthly administration of Vabysmo yielded prompt and sustained vision improvement in individuals with branch and central RVO.

It successfully met the primary objective of noninferior visual acuity gains at 24 weeks when compared to aflibercept. These results were further corroborated by data showing Vabysmo's ability to swiftly and effectively dry retinal fluid.

In both the BALATON and COMINO studies, Vabysmo demonstrated general tolerability, and its safety profile remained consistent with previous trials. The most frequently reported adverse reaction was conjunctival hemorrhage (3%). Safety outcomes were uniform across all study arms. In response to rare post-marketing occurrences of retinal vasculitis and/or retinal vascular occlusion, typically observed in the presence of intraocular inflammation, additional information has been incorporated into the 'Warnings & Precautions' section of the US label.

Genentech has reported that the incidence of retinal vasculitis with vascular occlusion is 0.06 per 10,000 injections, aligning with the reported real-world frequencies of other widely used intravitreal treatments for individuals dealing with wet AMD, DME, and RVO.

“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.”

As of now, Vabysmo has obtained approval in over 80 countries globally for individuals coping with wet AMD and DME, resulting in the distribution of approximately 2 million doses worldwide.

Vabysmo's mechanism of action focuses on the inhibition of two signaling pathways associated with several vision-threatening retinal conditions. This is achieved by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Although ongoing research seeks to enhance our understanding of the Ang-2 pathway's role in retinal disease, it is believed that both Ang-2 and VEGF-A contribute to vision impairment by destabilizing blood vessels, potentially leading to the formation of new leaky blood vessels and increased inflammation. Vabysmo's objective is to maintain the stability of blood vessels by blocking these pathways related to Ang-2 and VEGF-A.

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