Primary endpoints met in Vabysmo phase 3 studies for retinal vein occlusion
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Vabysmo achieved positive safety and efficacy results in two global phase 3 studies investigating its use for macular edema due to branch and central retinal vein occlusion, according to a press release from Genentech.
The bispecific antibody is designed to stabilize blood vessels by blocking disease pathways involving angiopoietin-2 and VEGF-A, which may contribute to vision loss by destabilizing blood vessels and increasing inflammation.
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The BALATON and COMINO studies met their primary endpoints, with Vabysmo (faricimab-svoa) injections every 4 weeks for up to 24 weeks achieving noninferiority visual acuity gains compared with aflibercept injections every 4 weeks in patients with macular edema due to BRVO and CRVO.
Additionally, Vabysmo showed efficacy in rapid drying of retinal fluid from baseline through week 24, as measured by reduction in central subfield thickness. It was well tolerated and had a safety profile consistent with previous trials.
“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 at Genentech, said in the release. “[These] results add to the extensive evidence supporting Vabysmo’s efficacy in treating multiple types of retinal conditions.”
Vabysmo was previously approved by the FDA for the treatment of wet age-related macular degeneration and diabetic macular edema.
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