Vabysmo improves vision, reduces retinal fluid in phase 3 retinal vein occlusion studies
Vabysmo met the primary endpoint of noninferior visual acuity gains compared with aflibercept treatment at 24 weeks in patients with retinal vein occlusion in the phase 3 BALATON and COMINO studies, according to a Genentech press release.
“After the initial topline results for Vabysmo in RVO from October showing good vision gains in BCVA and reduction in CST, the hope was there would be additional good data in the primary analysis,” Ramin Tadayoni, MD, PhD, lead investigator of the BALATON and COMINO studies, told Healio/OSN. “These promising results show that Vabysmo effectively reduces fluid in the retina, provides better sealing of vessels vs. aflibercept as measured by macular leakage, and improves vision in patients with retinal vein occlusion.”
Source: Adobe Stock.
Participants were randomly assigned 1:1 to receive six monthly injections of Vabysmo 6 mg (faricimab-svoa) or aflibercept 2 mg for 20 weeks for the treatment of macular edema due to branch and central retinal vein occlusion.
In BALATON, vision gains were 16.9 letters in those treated with Vabysmo compared with 17.5 letters in those treated with aflibercept. In COMINO, vision gains were 16.9 letters in those treated with Vabysmo compared with 17.3 letters in those treated with aflibercept.
As a secondary endpoint, there was “rapid and robust” retinal fluid drying from baseline. In BALATON, there was a reduction in central subfield thickness of –311.4 µm in those treated with Vabysmo compared with –304.4 µm in those treated with aflibercept. In COMINO, the reduction was –461.6 µm in those treated with Vabysmo compared with –448.8 µm in those treated with aflibercept.
In a prespecified exploratory endpoint, more participants treated with Vabysmo had an absence of blood vessel leakage in the retina compared with those treated with aflibercept. In BALATON, 34% of Vabysmo subjects had an absence of leakage compared with 21% of aflibercept subjects. In COMINO, 44% of Vabysmo subjects had an absence of leakage compared with 30% of aflibercept subjects.
According to Tadayoni, these findings are important because “less leakage generally means a drier retina, and a drier retina with less swelling and fluid is associated with clearer vision. Absence of leakage avoids also unnecessary burden on biological processes that dry the retina and preserve the retina.”
Both studies showed consistent safety results, with the most common adverse reaction being conjunctival hemorrhage in 3% of participants treated with Vabysmo.
Next, Genentech will evaluate data from weeks 24 to 72 to determine if Vabysmo dosing intervals can be extended up to every 4 months.
“These positive results are clinically relevant and indicate the potential of Vabysmo as a new treatment option for people with RVO, a vision-threatening condition that impacts more than 1 million people in the United States,” Tadayoni said. “If approved, this would be Vabysmo’s third indication.”
The FDA previously approved Vabysmo for the treatment of wet age-related macular degeneration and diabetic macular edema.
Editor’s note: This article was updated on Feb. 14, 2023, to include comments from the lead investigator.
Collapse
Read more about