Genentech’s investigational, refillable eye implant—designed to deliver a new formulation of Lucentis' active ingredient, ranibizumab, continuously to wet age-related macular degeneration patients—showed positive results in a phase 2 trial compared to the traditional delivery method.
Slightly longer than a grain of rice, the surgically implanted Port Delivery System allows patients to avoid the monthly eye injections required for the anti-VEGF therapy, and go several months between refills.
“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.
Vision outcomes in the high-dose implant group were similar to those of monthly Lucentis eye injections, including gains in visual acuity and reductions in central retina thickness, and were maintained throughout the study, the Roche Group company said in a statement.
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The majority of the 243 patients in the trial went six months or more before their first refill—performed as an in-office procedure using a customized needle—as Genentech looks to address undertreatment of the disease, which is a leading cause of blindness for people over 60. The Big Biotech plans to launch phase 3 development before the end of the year.
“If the PDS is successful, it could have a major impact on the way we treat people with wet AMD,” said study investigator Carl Regillo, M.D., chief of the retina service at Wills Eye Hospital in Philadelphia. “I believe that more consistent treatment could allow for better long-term vision outcomes in clinical practice.”
Additional data analyses continue, and Genentech plans to present them at future medical meetings.
Editor's note: This story was updated to clarify the PDS' formulation.