Roche has announced positive topline results from two identically designed global Phase III studies of its investigational bispecific antibody, faricimab, to treat people with diabetic macular edema (DME).
Designed for the eye, faricimab is an investigational bispecific antibody.
DME is a vision-threatening complication of diabetic retinopathy (DR). It occurs when blood vessels damage and the formation of new blood vessels causes blood and/or fluid to leak into the retina.
The randomised, multicentre, double-masked, Phase III studies YOSEMITE and RHINE analysed the efficacy and safety of faricimab versus aflibercept in 1,891 individuals living with DME.
YOSEMITE study enrolled 940 participants while RHINE study had 951 individuals.
Each study comprised three treatment arms which included faricimab 6mg given at personalised dosing intervals of up to 16 weeks, faricimab 6mg administered at fixed eight-week intervals and aflibercept 2mg given at fixed eight-week intervals.
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The average change in best-corrected visual acuity (BCVA) score from baseline at one year formed the primary endpoint of the studies.
Data showed that both the studies met their primary endpoint and demonstrated that faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks showed non-inferior visual acuity gains versus aflibercept given every eight weeks.
In addition, it was well-tolerated and no new safety signals have been noted.
In a secondary endpoint, over half of the subjects in the faricimab personalised dosing groups had extended time between treatments to 16 weeks at year one.
Roche chief medical officer and Global Product Development head Levi Garraway 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.”