Port Delivery System with ranibizumab meets primary endpoint
The Port Delivery System, a permanent refillable eye implant, with ranibizumab demonstrated positive phase 3 study results as a treatment for neovascular age-related macular degeneration, according to a Genentech press release.
The phase 3 Archway study evaluated the efficacy and safety of the PDS refilled every 6 months with ranibizumab compared with patients receiving monthly ranibizumab 0.5 mg intravitreal injections. The study, which included 418 participants with wet AMD, met its primary endpoint, in that patients with the PDS achieved equivalent visual acuity outcomes as patients treated with monthly injections.
Full data will be presented at an upcoming meeting, and the device will be submitted to the FDA and European Medicines Agency for consideration of regulatory approval, according to the release.
The Portal study is evaluating the PDS for its long-term safety and tolerability in wet AMD, while the Pagoda trial is evaluating the device in diabetic macular edema.