Genentech and Roche announced they have completed patient enrollment in the phase 3 YOSEMITE (NCT03622580) and RHINE (NCT03622593) clinical trials investigating faricimab in diabetic macular edema (DME) ahead of schedule. Together, these represent the largest clinical trials of an investigational medicine in DME to date.
Faricimab is the first bispecific antibody designed specifically for the treatment of retinal eye diseases. This investigational medicine simultaneously binds to and neutralizes Angiopoietin-2 (Ang2) and vascular endothelial growth factor A (VEGF-A). By targeting both Ang2 and VEGF-A, faricimab may lead to improved and sustained efficacy at longer treatment intervals, thereby delivering better vision outcomes for patients.
This news comes on the heels of another recently completed patient enrollment announcement for the phase 3 Archway (NCT03677934) clinical trial investigating the Port Delivery System with ranibizumab (PDS) in people with wet age-related macular degeneration (AMD) in July.
The YOSEMITE and RHINE phase 3 studies will evaluate the safety and efficacy of faricimab for the treatment of DME compared to aflibercept injection. In each study, more than 900 patients around the world will be randomized to one of three arms: Arm A will receive faricimab dosed every eight weeks or sham injections, Arm B will be a personalized treatment interval arm where patients will be dosed according to the study protocol or sham injections, and Arm C will receive aflibercept dosed every eight weeks or sham injections. The primary endpoint of each study is the change in Best-Corrected Visual Acuity (BCVA) at 1 year. YOSEMITE and RHINE aim to confirm the significant and sustained vision gain results in the phase 2 BOULEVARD study.
“Genentech remains committed to researching and developing new treatments for people living with DME and other vision-threatening diseases,” Dr. Christopher Brittain, Global Head of Genentech’s Ophthalmology Clinical Development program, said in a company statement. “We are so thankful to the patients and investigators who helped us complete enrollment in these trials ahead of schedule.”
In addition to investigating faricimab for DME, Genentech and Roche continue to enroll patients in the phase 3 TENAYA and LUCERNE studies evaluating faricimab for the treatment of wet AMD. Faricimab and the PDS are two late-stage pipeline medicines for wet AMD and DME in Genentech and Roche’s ophthalmology franchise, building upon the foundation laid by Lucentis, which was first approved by the FDA for wet AMD in 2006.