Roche announced positive new data from two global phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO) at 24 weeks.
The research indicated that the use of Vabysmo led to a quick and lasting improvement in vision, reaching the primary endpoint of equivalent visual acuity improvement compared to aflibercept treatment. Additionally, Vabysmo exhibited a prompt and substantial decrease in retinal fluid as demonstrated by a decrease in the thickness of the central subfield.
The safety of Vabysmo was in line with previous trials. The findings will be shared online on February 11th during the Angiogenesis, Exudation and Degeneration 2023 conference, hosted by the Bascom Palmer Eye Institute located in Florida, USA.
If approved, RVO would be the third indication for Vabysmo in addition to neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema.
“These encouraging results reinforce the potential of Vabysmo as a new treatment option for people experiencing vision loss associated with retinal vein occlusion,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “As these positive data continue to accrue, we believe Vabysmo may redefine the standard of care for multiple types of retinal conditions that can cause blindness.”
RVO, neovascular or "wet" age-related macular degeneration (nAMD), and diabetic macular edema (DME) affect approximately 70 million individuals globally and are considered significant contributors to vision loss. The results from the BALATON and COMINO studies will be submitted to various healthcare regulatory bodies, including the United States Food and Drug Administration and the European Medicines Agency, for consideration of approval as a treatment for macular edema caused by RVO.
“Retinal vein occlusion can cause fluid to become trapped within and under the retina, leading to rapid and severe vision loss if left untreated,” said Ramin Tadayoni, M.D., Ph.D., president-elect of EURETINA, who is presenting the data at Angiogenesis. “These promising results show that Vabysmo effectively reduces fluid in the retina and improves vision in patients with retinal vein occlusion.”
The effectiveness and safety of Vabysmo in treating nAMD and DME have been demonstrated by data from four large-scale, worldwide studies that included over 3,000 individuals and spanned two years. Vabysmo is the first bispecific antibody approved for ocular use and its phase III trials support treatment intervals of up to four months for individuals with these conditions. It neutralizes angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), two signaling pathways that are associated with various vision-threatening retinal issues. To date, over 450,000 doses of Vabysmo have been distributed globally for the treatment of these conditions.
Click to see the study results.