Genentech announces positive Phase III results for faricimab
pharmafile | December 22, 2020 | News story | Manufacturing and Production |
Genentech, a member of the Roche group, today announced positive top-line results from two identically designed global Phase III studies of its investigational bispecific antibody, faricimab, in people living with diabetic macular edema (DME).
The studies, YOSEMITE and RHINE, met their primary endpoint and showed that faricimab given every eight weeks, and at personalised dosing intervals of up to 16 weeks, demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks. Faricimab was generally well tolerated with no new safety signals identified.
In secondary endpoints across both studies, more than half of participants in the faricimab personalised dosing arms achieved an extended time between treatments of 16 weeks at year one; this is the first time any investigational medicine has achieved this level of durability in a Phase III study of people with DME.
There are an estimated 750,000 Americans living with DME, a leading cause of vision loss among working-age adults. While anti-vascular endothelial growth factor (VEGF) monotherapy injections have significantly reduced vision loss from the condition, the treatment burden associated with frequent eye injections and physician visits can lead to under-treatment and, potentially, less than optimal vision outcomes.
It has been almost 10 years since a medicine with a new mechanism of action has been approved to treat DME, and faricimab is the first investigational bispecific antibody designed for the eye.
Dr Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, said: “These positive results show that faricimab has the potential to offer lasting vision improvements for people with diabetic macular edema, while also reducing the treatment burden associated with frequent eye injections.
“We look forward to discussions with global regulatory authorities, with the aim of bringing this potential new treatment option to people with this condition as soon as possible.”
Darcy Jimenez
