Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved “Vabysmo” (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). This approval is the third indication for Vabysmo, in addition to wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). According to the company, the three retinal conditions affect around 3 million people in the U.S. and are among the leading causes of vision loss.
Genentech’s Vabysmo is a bispecific antibody that targets and inhibits two signalling pathways linked to a number of retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), aimed to stabilize blood vessels in the retina. Approval of the treatment was under-pinned by Phase III BALATON and COMINO studies. BALATON (NCT04740905) and COMINO (NCT04740931) are two randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of faricimab-svoa, compared to aflibercept. According the sponsor, for the first 20 weeks, patients were randomized 1:1 to receive monthly injections for six months of either faricimab-svoa (6.0 mg) or aflibercept (2.0 mg). From weeks 24 to 72, all patients received faricimab-svoa (6.0 mg) up to every four months, using a treat-and-extend dosing regimen. The BALATON study was conducted in 553 people with branch retinal vein occlusion and the COMINO study was conducted in 729 people with central retinal or hemi-retinal vein occlusion. In summary, the primary end point was noninferiority of faricimab versus aflibercept in mean change from baseline in BCVA (week 24; noninferiority margin: 4 letters). Secondary end points (weeks 0–24) were mean change from baseline in BCVA, CST, and National Eye Institute Visual Function Questionnaire 25 composite score; proportion of patients gaining or avoiding loss of ≥ 15/≥ 10/≥ 5/> 0 letters. Secondary end points (weeks 24–72) were treatment durability (week 68); continuation of weeks 0 to 24 end points. In total, 1,282 patients were evaluated across 22 countries in 149 and 193 centres in BALATON and COMINO, respectively.
Genentech estimates from a 2018 analysis suggests there were approximately 28.1 million adults with RVO worldwide, including 23.4 million with BRVO and 4.7 million with CRVO. After diabetic retinopathy, RVO is the second leading cause of retinal vascular disease and a common cause of vision loss. Following the announcement for the recent approval, Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development stated that, “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.”