Roche and Genentech have initiated two large global Phase III clinical trials testing the potential of bispecific antibody faricimab in wet age-related macular degeneration.
The proposed studies – TENAYA and LUCERNE – will evaluate the efficacy, safety and durability of faricimab compared to aflibercept for the treatment of wet AMD.
Combined, nearly 1,300 patients with wet AMD will be randomised to receive either faricimab dosed at every 16 weeks, or aflibercept dosed every eight weeks.
Faricimab is the first bispecific antibody designed specifically for the treatment of retinal eye diseases that simultaneously binds to and inactivates Angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A).
By targeting both Ang-2 and VEGF-A, faricimab may lead to sustained efficacy at longer treatment intervals, thereby improving vision outcomes for patients. The drug is also currently being studied in patients with diabetic macular oedema.
“The impact of wet AMD on patients, their families and caregivers is one of the reasons Genentech and Roche are dedicated to bringing novel treatments, like faricimab, to patients and their retina specialists. While effective therapies for wet AMD exist, the treatment burden may lead to less than optimal vision outcomes for many patients over time,” said Carlos Quezada Ruiz, medical director of Ophthalmology at Genentech.