Roche‘s (OTC:RHHBY) Genentech reported this week that the company launched Phase III trials evaluating its Port drug-delivery implant in patients with wet age-related macular degeneration and the drug faricimab in patients with diabetic macular edema.
The company’s Port device is a refillable eye implant designed to continuously release drugs over a period of several months.
“Wet AMD and DME are serious, potentially blinding eye conditions that create a heavy burden on patients and their families. The PDS and faricimab represent the next generation of potential treatment options for these patients and demonstrate Genentech and Roche’s commitment to developing new medicines,” Christopher Brittain, ad interim global head of Genentech’s ophthalmology clinical development program, said in prepared remarks. “We are encouraged by the results we’ve seen in our Phase II studies and are excited that recruitment for the Phase III programs is underway.”
The Phase III Archway study is slated to assess the Port system for the treatment of wet AMD using fixed-interval dosing. Patients will either receive a special formulation of ranibizumab administered via the Port system with refills at 24-week intervals or monthly intravitreal injections of ranibizumab. The trial’s primary endpoint is the change from baseline in best-corrected visual acuity over weeks 36 and 40, according to Genentech.
In a Phase II study, 80% of the patients in the high-dose Port group went six months before needing their first refill.
The Phase III Yosemite and Rhine trials are designed to test the safety and efficacy of faricimab for the treatment of DME compared to aflibercept injections. In both studies, participants will be randomized into three groups: one group will receive faricimab dosed every eight weeks or sham injections; another group will receive injections according to a personalized treatment plan or sham injections; the third group will receive aflibercept dosed every eight weeks or sham injections.
The primary endpoint of the studies, which Genentech touted as the largest studies of DME to date, is the change in best-corrected visual acuity at one year.
This story was updated on 10/8/18 to clarify that the Port drug-delivery system is not being used in the faricimab DME study.