Genentech has announced positive, top line results from a Phase 2 study of its Port Delivery System (PDS) with Lucentis in people with wet age-related macular degeneration (AMD).
The small, refillable eye implant, which is slightly longer than a grain of rice, is designed to allow people with wet AMD to go several months without needing to visit their ophthalmologist for treatment. The majority of PDS patients enrolled in the LADDER trial went six months or longer between implant of the device and the first, required refill. Vision outcomes in the high-dose PDS group were similar to monthly Lucentis eye injections and were maintained throughout the study period.*
“If the PDS is successful, it could have a major impact on the way we treat people with wet AMD,” said Carl D. Regillo, M.D., FACS, investigator for the LADDER study. “I believe that more consistent treatment could allow for better long-term vision outcomes in clinical practice.”
The current standard of care for wet AMD can be burdensome because it requires patients to visit their ophthalmologist as often as monthly for eye injections of anti-vascular endothelial growth factor (VEGF) therapy to help maintain vision gains and/or prevent vision loss. This high treatment burden with anti-VEGF therapy can lead to under-treatment of wet AMD and, potentially, less than optimal vision outcomes.
“LADDER is the first successful Phase II study of a long-acting delivery device for the treatment of wet AMD. We are highly encouraged by these results and the potential of the PDS, our first implantable, drug delivery program,” said Sandra Horning, M.D. (chief medical officer and head of Global Product Development). “With the PDS, we have an opportunity to make a positive impact by helping to potentially eliminate the burden of frequent treatments for people with wet AMD.”
LADDER study patients implanted with the PDS received one of three concentrations of Lucentis. For PDS patients receiving 100 mg/mL, approximately 80 percent were able to go six months or longer until their first refill was required. Of the PDS patients receiving 40 mg/mL or 10 mg/mL, 71.3 percent and 63.5 percent, respectively, were able to go six months or longer before their first refill.
The PDS is implanted surgically. It is refilled using a customized needle in a minimally invasive clinical procedure. The results from this study will help determine the most appropriate dose and fixed treatment interval to study in the Phase III program, which is expected to begin later in 2018.
*Data presented by Carl C. Awh, M.D. at the 2018 meeting of the American Society of Retina Specialists (ASRS), Vancouver, British Columbia, Canada.
SOURCE: Genentech press release