Phase 3 trials to focus on Port Delivery System for AMD, faricimab for DME
Genentech and Roche announced the initiation of three large phase 3 clinical trials evaluating the Port Delivery System with ranibizumab to treat wet age-related macular degeneration and faricimab to treat diabetic macular edema, according to company correspondence.
The Port Delivery System is a refillable eye implant that continuously releases a formulation of ranibizumab over a period of several months. The delivery system will be evaluated in the phase 3 Archway study, the first phase 3 trial with a device used for the sustained delivery of an anti-VEGF therapy. The trial will evaluate the delivery system for the treatment of wet AMD using fixed interval dosing, with the primary endpoint being the change from baseline in best corrected visual acuity over weeks 36 to 40.
Faricimab is a bispecific antibody designed for the treatment of retinal eye disease that binds to and inactivates VEGF-A and Ang-2. The phase 3 YOSEMITE and RHINE trials will evaluate the safety and efficacy of faricimab for the treatment of DME compared with aflibercept injection. The studies will include 1,200 patients randomly assigned to one of three arms; the first will receive faricimab every 8 weeks or sham injections, the second will receive personalized treatment in which patients are dosed according to the study protocol or sham injections, and the third will receive aflibercept every 8 weeks or sham injections.