- The Port Delivery System with ranibizumab (PDS) consists of an intraocular drug delivery implant and ancillary devices to enable initial fill, refill and explantation of the implant.
- The implant is a permanent, indwelling drug delivery device that can be refilled in situ through a self-sealing septum and is designed to continuously release a customized formulation of ranibizumab into the vitreous by passive diffusion through a porous titanium release control element.
- Sustained, continuous, and reproducible release from the PDS characterized in the in-vitro studies was also observed in Ladder (phase 2) and Archway (phase 3) trials.
- PDS is the first long-acting ocular biologic drug delivery system, demonstrated to be clinically effective in providing visual and anatomic outcomes comparable to monthly injections in nAMD with refill-exchange intervals of at least 6 months.
The Port Delivery System with ranibizumab (PDS) is an innovative intraocular drug delivery system designed for the continuous delivery of ranibizumab into the vitreous for 6 months and beyond. Development of the PDS included in vitro studies performed to characterize ranibizumab release from the implant and the efficiency of refill-exchange. Ranibizumab release rate from the PDS implant was measured in vitro with different starting concentrations of ranibizumab and active release rate determined both after the initial fill and after refill-exchanges. Measurements after initial fill, first, second, and third refills, respectively, demonstrated reproducibility between implants and between multiple refill-exchanges of the same implant. A refill-exchange performed with a single stroke (100 µL) using the refill needle replaced over 95% of the implant contents with fresh drug. In vitro data support the use of the PDS with fixed refill-exchange intervals of at least 6 months in clinical trials.
Shrirang Ranade, Sr. Technical Development (CMC) Team Leader, Genentech
