Genentech has reported end-of-trial results examining the use of their unique alternative to intravitreal injections, the Port Delivery System (PDS).
As reported previously here, the PDS is a tiny refillable implant that provides patients affected by wet age-related macular degeneration (AMD) with continuous delivery of Lucentis (ranibizumab) as necessary.
Presented by Carl Regillo, MD, at the 2019 annual meeting of the American Academy of Ophthalmology (AAO), results revealed 60% of patients went more than a year without needing a refill and PDS was well-tolerated through the end of the study.
The phase 2 LADDER study enrolled a total of 220 patients who were treated at various dosage levels. In the 100 mg/mL group, the mean time to first refill was 15.8 months. In the 40 mg/mL and 10 mg/mL groups, mean time was 13.0 months and 8.7 months, respectively.
“From a safety standpoint the PDS was very well tolerated throughout the entire study time frame of 22 months on average—up to 38 months in some patients—and no significant changes in the overall safety profile,” Regillo said.
SOURCE: “Port Delivery System with Ranibizumab (PDS) for Neovascular AMD (nAMD): Ladder Phase 2 Trial End of Study Results,” presented by Carl Regillo, MD, (director of retina service, Wills Eye Hospital, and professor of ophthalmology, Thomas Jefferson University).