We reported here in October 2019 that Genentech had reported good Phase 2 trial results examining the use of their unique alternative to intravitreal injections. The Port Delivery System (PDS) is a tiny refillable implant that provides patients affected by wet (neovascular) age-related macular degeneration with continuous delivery of Lucentis as necessary.
The company has now announced that Phase III data from their Archway trial show that the PDS enabled over 98% of patients to go six months between treatments. The PDS is the first wet AMD therapy to achieve positive Phase III results for this extended length of time between treatments. The current standard of care for wet AMD requires patients to visit their ophthalmologist as often as monthly for eye injections of anti-VEGF therapy to help maintain vision gains or prevent vision loss. This high treatment burden can lead to under-treatment and, potentially, less than optimal vision outcomes.
“For over a decade, we have been working to develop new treatments that better address the unmet needs of people living with neovascular [wet] AMD,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Based on these data, we believe that the continuous delivery mechanism enabled by PDS may offer effective, reliable results while also alleviating the treatment burden. We are excited to share the data with regulatory authorities with the aim of bringing this new treatment option to patients as soon as possible.”
Rollout of the PDS is expected in the U.S. in 2021 and beyond the U.S. in 2022.
SOURCE: Press Release