Roche and Genentech have initiated two large global phase 3 clinical trials in wet age-related macular degeneration (AMD) investigating the bispecific molecule, faricimab. 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, according to a Genentech statement.
The identically designed, multicenter, randomized, double-masked, active comparator-controlled phase 3 TENAYA (NCT03823287) and LUCERNE (NCT03823300) studies will evaluate the efficacy, safety, and durability of faricimab compared to aflibercept for the treatment of wet AMD. In total, nearly 1,300 patients with wet AMD will be randomized to receive either faricimab dosed at every 16 weeks (with an option to drop to every 12 or 8 weeks), or aflibercept dosed every 8 weeks. The primary endpoint of each study is the change in Best-Corrected Visual Acuity (BCVA) at week 48 from baseline.
“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,” Carlos Quezada Ruiz, MD, Medical Director, Ophthalmology at Genentech, said in the statement.
At the American Academy of Ophthalmology (AAO) meeting in October 2018, results from the Phase II STAIRWAY study in wet AMD showed that, by the end of the study, patients receiving faricimab, when dosed either every 16 weeks or every 12 weeks, experienced robust and sustained vision gains comparable to patients who received ranibizumab dosed every 4 weeks, demonstrating the potential for extended durability with faricimab.
Faricimab is also being studied in patients with diabetic macular edema (DME). The global phase 3 YOSEMITE (NCT03622580) and RHINE (NCT03622593) studies, announced in September 2018, aim to confirm the significant vision gains and durability results in the phase 2 BOULEVARD study and represent the largest studies of DME to date. YOSEMITE and RHINE are evaluating the efficacy, safety and durability of faricimab for the treatment of DME compared to aflibercept.