Roche’s Vabysmo Receives EU Approval
The European Commission has approved Roche’s Vabysmo (faricimab) for the treatment of neovascular or ‘wet’ age-related macular degeneration and visual impairment due to diabetic macular edema — two leading causes of vision loss.
The drug requires fewer eye injections over time, with phase 3 studies supporting treatment at intervals of up to four months, the company said.
The approval was based on positive results from four phase 3 studies showing that people treated with Vabysmo, given at intervals of up to four months achieved similar vision gains and anatomical improvements compared to those given aflibercept every two months.
Data at two years showed that more than 60 percent of people treated with Vabysmo were able to extend their treatments to every four months.
September 20, 2022
https://www.fdanews.com/
The drug requires fewer eye injections over time, with phase 3 studies supporting treatment at intervals of up to four months, the company said.
The approval was based on positive results from four phase 3 studies showing that people treated with Vabysmo, given at intervals of up to four months achieved similar vision gains and anatomical improvements compared to those given aflibercept every two months.
Data at two years showed that more than 60 percent of people treated with Vabysmo were able to extend their treatments to every four months.
September 20, 2022
https://www.fdanews.com/
