Roche (ROG: SIX) group member Genentech has revealed positive top-line results from the Phase II LADDER study of its investigational Port Delivery System with ranibizumab (PDS) in people with wet age-related macular degeneration (AMD).
The PDS system is a small, refillable eye implant designed to allow people with wet AMD to go several months without needing to visit the doctor.
Most PDS patients enrolled in the LADDER trial went six months or longer between implant of the device and the first required refill.
At the higher dose level tested, around 80% were able to go six months or longer until their first refill was required. At the lower dose levels, the figures were 71.3% and 63.5%.
Vision outcomes in the high-dose PDS group were similar to monthly already-marketed Lucentis (ranibizumab) eye injections and were maintained throughout the study period.
Roche chief medical officer Sandra Horning said: “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. 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.”
The firm says that additional data analyses will be presented in future, and that the PDS Phase III clinical development program is expected to begin later in 2018.