Jun 14, 2021

Consistency key to port delivery system

by: lynda-charters

Reviewed by Carl Regillo, MD

The Port Delivery System(PDS) with ranibizumab (Lucentis, Genentech Inc.), an investigational drug delivery system designed for continuous long-term intravitreal drug delivery to treat neovascular age-related macular degeneration (nAMD), was found to be safe and efficacious in the phase 3 Archway trial, which evaluated fixed refill exchanges done every 24 weeks compared with monthly injections of ranibizumab.

Carl Regillo, MD, director of retina service at Wills Eye Hospital and a professor of ophthalmology at Thomas Jefferson University, Philadelphia, Pennsylvania, reported the trial results on behalf of the study investigators.

Data up to September 2020

The Archway trial has 2 treatment arms: patients randomly assigned to treatment with the PDS and patients randomly assigned to monthly intravitreal injections of ranibizumab.

Patients in both arms had received, on average, about 5 injections over 5 months after the diagnosis of nAMD and had a mean best-corrected visual acuity (BCVA) of 20/32 at baseline.

The primary endpoint result, i.e.—the change in the mean BCVA from baseline averaged over weeks 36 to 40—was an increase of +0.2 letters in the PDS arm and +0.5 letters in the injection arm.

About 80% of patients had 20/40 or better BCVA in both arms. The PDS treatment was seen to be both non-inferior and equivalent to monthly injections, Regillo reported.

The data evaluation at 48 weeks included 2 refills of the PDS and showed that the ongoing VA results were consistent with the primary analysis in that the PDS results were non-inferior to monthly dosing….

Read more: https://www.ophthalmologytimes.com/view/consistency-key-to-port-delivery-system

Source: Ophthalmology Times

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