March 13, 2023
1 min learn
Khanani A, et al. Port Supply System with ranibizumab in sufferers with diabetic macular edema: Main evaluation outcomes of the section 3 Pagoda trial. Offered at: Angiogenesis, Exudation, and Degeneration 2023; Feb. 10-11, 2023 (digital assembly).
Khanani reviews consulting for and receiving analysis help from Genentech.
Ranibizumab 100 mg/mL delivered with the Port Supply System with a 24-week refill price was noninferior to month-to-month ranibizumab 0.5 mg injections for the remedy of diabetic macular edema, in line with a presenter.
“The Port Supply System is designed for steady supply of ranibizumab,” Arshad M. Khanani, MD, MA, FASRS, mentioned at Angiogenesis, Exudation, and Degeneration 2023. “For diabetic macular edema, it presents a technique to take care of medical advantages of month-to-month intravitreal anti-VEGF remedy whereas lowering general remedy burden.”
The section 3 Pagoda trial was designed to research the efficacy, security and pharmacokinetics of DME remedy utilizing the Port Supply System (PDS, Genentech). The first endpoint of the trial was noninferiority of the PDS with refill-exchange each 24 weeks in contrast with intravitreal injections of ranibizumab each 4 weeks primarily based on finest corrected visible acuity averaged over weeks 60 and 64. The examine included 634 sufferers with DME who had been randomly assigned to remedy with the PDS (381 sufferers) or intravitreal ranibizumab (253 sufferers).
Adjusted imply change from baseline in BCVA rating was 9.6 letters, averaged over weeks 60 and 64, in sufferers handled with the PDS in contrast with 9.4 letters in sufferers handled with intravitreal ranibizumab.
The PDS was usually effectively tolerated, with no reported circumstances of endophthalmitis or retinal detachment after implantation by way of week 64 of the examine. Ocular hostile occasions of particular curiosity after the process, resembling implant dislocation, septum dislodgement and vitreous hemorrhage, had been manageable.
The PDS additionally confirmed “comparable and clinically vital enhancements” in central subfield thickness and diabetic retinopathy in contrast with ranibizumab injections, Khanani mentioned.
Greater than 95% of sufferers handled with the PDS didn’t obtain any supplemental therapies between refills of ranibizumab throughout two refill cycles.
“PDS Q24 weeks resulted in sturdy imaginative and prescient outcomes in comparison with month-to-month ranibizumab 0.5 mg injections,” Khanani mentioned. “Steady supply of ranibizumab with PDS resulted in imaginative and prescient and anatomical outcomes similar to month-to-month injections.”
The PDS, now often called Susvimo, was accredited for the remedy of moist age-related macular degeneration in 2021.