Roche‘s (OTC:RHHBY) Genentech touted positive top-line data today from a Phase II study of its Port Delivery System, an eye implant designed to administer a sustained dose of ranibizumab in patients with wet age-related macular degeneration.
The refillable device, which is slightly longer than a grain of rice, is intended to enable wet-AMD patients to go for months without needing to see an ophthalmologist for treatment. The current standard of care for wet-AMD involves monthly injections of anti-vascular endothelial growth factor therapy.
Genentech reported that the majority of people enrolled in its Phase II Ladder trial went at least six months between receiving the device and the first refill. Vision outcomes, presented today by Dr. Carl Awh, for the high-dose PDS group were comparable to monthly injections with ranibizumab, the company noted.
“If the PDS is successful, it could have a major impact on the way we treat people with wet AMD,” investigator Dr. Carl Regillo said in prepared remarks. “I believe that more consistent treatment could allow for better long-term vision outcomes in clinical practice.”
“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,” Dr. Sandra Horning, CMO & head of global product development, added. “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.”
Genentech noted that it hopes to use the results from its 243-patient Phase II Ladder study to inform the design of its Phase III clinical program, which is slated to begin later this year.
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.