European Commission approves Vabysmo for retinal vein occlusion
Click Here to Manage Email Alerts
The European Commission approved Vabysmo for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion, according to a press release from Roche.
“Vabysmo is the first bispecific antibody approved for RVO and the first new treatment for people with RVO in the European Union since 2015,” a Roche spokesperson told Healio. “By potentially extending the time between treatments to up to 4 months while maintaining vision, Vabysmo could offer a less burdensome treatment schedule for people living with RVO, their caregivers and health care systems.”
The approval was based on positive data from more than 1,200 patients in the phase 3 BALATON and COMINO studies in which Vabysmo (faricimab) met the primary endpoint of noninferiority vs. aflibercept in visual acuity gains at 24 weeks. Vabysmo demonstrated “early and sustained” vision improvements as well as retinal fluid drying in patients with branch and central retinal vein occlusion, according to the release.
Nearly 60% of participants treated with Vabysmo in BALATON and approximately 48% in COMINO extended their treatment intervals to 3 or 4 months apart. The bispecific antibody was well tolerated in both studies.
“We are working closely with patient organizations, governments, regulatory and reimbursement authorities in the EU to bring Vabysmo to eligible patients as soon as possible,” the spokesperson said.
As Healio previously reported, the FDA approved Vabysmo for the treatment of macular edema following retinal vein occlusion in October 2023.
Collapse
Read more about
Click Here to Manage Email Alerts