Genentech announced positive topline results from two global phase 3 studies, BALATON and COMINO, evaluating the first and only bispecific antibody for the eye, Vabysmo (faricimab-svoa), in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).
Both studies met their primary endpoints, showing that people with macular edema due to BRVO and CRVO receiving Vabysmo injections every 4 weeks, for up to 24 weeks, achieved noninferior visual acuity gains compared to those receiving aflibercept injections every 4 weeks.
“These encouraging data demonstrate that Vabysmo could potentially provide a new treatment option for people living with retinal vein occlusion, a serious retinal vascular condition that can lead to irreversible vision impairment or vision loss,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a company news release. “Today’s results add to the extensive evidence supporting Vabysmo’s efficacy in treating multiple types of retinal conditions. We look forward to submitting these data to regulatory authorities.”
Vabysmo also showed rapid drying of retinal fluid from baseline through week 24, as measured by reduction in central subfield thickness.
Vabysmo was generally well tolerated in both studies. The safety profile matched that of earlier studies.
Detailed findings will be presented to regulatory bodies worldwide and discussed at a forthcoming medical congress.
Vabysmo targets and inhibits two disease 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. The level of Ang-2 is elevated in RVO and it is thought that increased Ang-2 expression drives disease progression.
In more than 40 nations worldwide, including the United States, Japan, the United Kingdom, and the European Union, Vabysmo has received approval for the treatment of wet, or neovascular, age-related macular degeneration (AMD), as well as diabetic macular edema (DME).
Vabysmo’s long-term efficacy and safety in wet AMD and DME has been demonstrated by two-year data from four large, global studies involving more than 3,000 participants. Vabysmo is the only injectable eye medicine approved for wet AMD and DME by the U.S. Food and Drug Administration (FDA) with the option for treatments from one to four months apart in the first year following four initial monthly loading doses, based on evaluation of the patient’s anatomy and vision outcomes.
Globally, more than 165,000 Vabysmo doses have been distributed for treatment of these conditions to date. RVO, wet AMD and DME together affect around 3 million people in the United States and are among the leading causes of vision loss.