New Long-Term Data for Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO)

Genentech announced new 72-week data from two global phase 3 studies, BALATON and COMINO, evaluating Vabysmo (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). The data showed nearly 60% of people receiving Vabysmo in BALATON and up to 48% of people in COMINO were able to extend their treatment intervals to 3 or 4 months apart. In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than 1 year, according to Genentech. In both studies, Vabysmo was well tolerated and the safety profile was consistent with previous studies. 

“This is the first time that vision and anatomical improvements have been maintained for more than a year in global phase 3 studies for both branch and central retinal vein occlusion,” Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global Product Development, said in a company news release. “These long-term results build on the strong clinical and real-world data reinforcing Vabysmo as an effective treatment option for people affected by retinal conditions that can cause vision loss.”

Results will be presented virtually on February 3 at Angiogenesis, Exudation, and Degeneration 2024, organized by Bascom Palmer Eye Institute in Florida.

“The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion,” said Ramin Tadayoni, MD, PhD, head of ophthalmology at Université Paris Cité in Paris and president of Euretina, who is presenting the data at Angiogenesis. “More treatment options are needed to better serve people living with this condition, and these data show Vabysmo can potentially improve outcomes while reducing the number of clinic visits needed.”

Both studies evaluated the average change in best-corrected visual acuity (BCVA) score from baseline. The studies also tracked the amount of swelling in the back of the eye due to retinal fluid, as measured by central subfield thickness (CST). Reductions in CST indicate improvement. Overall, results showed the vision improvements and reductions in retinal fluid achieved in the first 24 weeks of the studies were maintained up to 72 weeks, according to Genentech.

Results for BRVO (BALATON):

• Vision gains: At 72 weeks, people receiving Vabysmo as a first-line treatment gained 18.1 letters on the eye chart, while people switched from aflibercept to Vabysmo gained 18.8 letters. During the first 24 weeks, vision gains were +16.8 eye chart letters in people receiving Vabysmo and +17.5 letters in people receiving aflibercept.
• Retinal drying: At 72 weeks, people receiving Vabysmo as a first-line treatment saw a 310.9 µm reduction in retinal swelling, as measured by CST, while those switched from aflibercept to Vabysmo saw a reduction in CST of 307 µm. During the first 24 weeks of the study, CST reductions were 314.5 µm in people receiving Vabysmo and 307.6 µm in people receiving aflibercept.

Results for CRVO (COMINO):

• Vision gains: People receiving Vabysmo as a first-line treatment gained 16.9 eye chart letters at 72 weeks, while people switched from aflibercept to Vabysmo gained 17.1 eye chart letters. During the first 24 weeks of the study, vision gains were +16.9 eye chart letters in people receiving Vabysmo and +17.3 letters in people receiving aflibercept.
• Retinal drying: People receiving Vabysmo as a first-line treatment saw a 465.9 µm reduction in retinal swelling, as measured by CST, while those switched from aflibercept to Vabysmo saw a reduction in CST of 460.6 µm at 72 weeks. During the first 24 weeks of the study, reductions in CST were 462.3 µm in people receiving Vabysmo and 447.8 µm in people receiving aflibercept.

Vabysmo is the first and only bispecific antibody approved for the eye. It 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.  

In October 2023, the FDA approved Vabysmo for the treatment of macular edema following RVO.