Archway Story: wk 48 efficacy, safety, safety in context, and PK*
The pivotal phase 3 Archway trial investigated the safety and efficacy of the Port Delivery System with ranibizumab (PDS) 100 mg/mL with fixed refill-exchanges every 24 weeks versus monthly intravitreal ranibizumab 0.5 mg injections in patients with neovascular age-related macular degeneration. The primary endpoint was change in best-corrected visual acuity score from baseline averaged over weeks 36 and 40. Here we report results from the September 2020 data cut, including efficacy data through week 48 (2 full refill-exchange intervals for PDS-treated patients) and safety findings through an average of 38 additional weeks of follow-up per patient.