This is additional information to a recent article called “Genentech’s first implantable drug delivery system shows promising results in phase 2 wet AMD trial”
Device Extends Treatment Interval for AMD
In a phase II study, the median time to first refill was 15 months among patients randomized to the highest concentration of ranibizumab (Lucentis). Patients assigned to lower concentrations of the anti-VEGF agent had median refill times of 13 and 8.7 months. A standard-therapy control group received monthly injections of ranibizumab.
“The phase II goal was achieved, as dose-response was observed across the endpoints,” Awh said in conclusion. “In the group that received the PDS with the 100 mg/mL concentration of ranibizumab, the median time to first required refill exceeded 15 months, and 80% of patients went 6 months or longer until the first required refill. Best corrected visual acuity (BCVA) and anatomic outcomes were comparable to those of monthly intravitreal ranibizumab.
“The PDS implant insertion surgery and refill procedure were well tolerated. The systemic safety was comparable to monthly intravitreal injections.”
A phase III trial of the PDS with fixed-interval dosing will begin by the end of 2018, he added.
Slightly larger than a grain of rice, the PDS addresses one of the key drawbacks to anti-VEGF therapy for AMD: need for regular intravitreal injections, which can occur as often as monthly. The PDS has a proprietary delivery mechanism that provides for continual delivery of a preset amount of drug comparable to monthly injections…..
Source: Medpage Today