Roche announced positive topline results from two global phase III studies, BALATON and COMINO, evaluating the first and only bispecific antibody for the eye, Vabysmo (faricimab), in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). RVO is a vision-threatening condition that impacts 28 million people globally.
Both studies met their primary endpoints, showing that people with macular edema due to BRVO and CRVO receiving Vabysmo injections every four weeks, for up to 24 weeks, achieved non-inferior visual acuity gains compared to those receiving aflibercept injections every four 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,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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.
In both studies, Vabysmo was generally well tolerated. The safety profile was consistent with previous trials.
Detailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the world.
Vabysmo is uniquely engineered to target and inhibit two disease pathways, which are linked to a number of vision-threatening retinal conditions, by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) to restore vascular stability. The level of Ang-2 is elevated in RVO and it is thought that increased Ang-2 expression drives disease progression.
To date, Vabysmo is approved in more than 40 countries around the world, including the United States, Japan, the United Kingdom and the European Union, for people living with neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Vabysmo’s long-term efficacy and safety in nAMD 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 with phase III studies supporting treatment intervals of up to four months for people living with nAMD and DME. Globally, more than 165,000 Vabysmo doses have been distributed for treatment of these conditions to date. RVO, nAMD and DME together affect around 70 million people worldwide and are among the leading causes of vision loss.