ePoster

Die hochgeladenen ePoster sind nur für eingeloggte Teilnehmende ersichtlich.

Bitte loggen Sie sich ein, um zu den ePoster zu gelangen.

Detaillierte Beitrags-Information

Beitragstitel	The Port Delivery System With Ranibizumab (PDS) Is Back to Enable Continuous Delivery of Anti-VEGF Therapy For Patients with nAMD, DME, and DR
Beitragscode	P23
Autor:innen	Matthias Becker Zurich City Hospital, Zurich, Switzerland Präsentierende:r Eugene de Juan Department of Ophthalmology, University of California, San Francisco, San Francisco, CA; Forsight Labs, San Francisco, CA Peter A. Campochiaro The Wilmer Eye Institute, Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, MD Margaret Chang Retinal Consultants Medical Group, Sacramento, CA, USA Nancy Holekamp F. Hoffmann-La Roche Ltd. Shamika Gune Genentech, Inc., South San Francisco, CA, USA Carlos Quezada-Ruiz Genentech, Inc., South San Francisco, CA, and Clínica de Ojos Garza Viejo, San Pedro Garza Garcia, Nuevo León, Mexico Geoffrey Wise Genentech, Inc., South San Francisco, CA, USA Shrirang Ranade Genentech, Inc., South San Francisco, CA, USA Joshua Horvath Genentech, Inc., South San Francisco, CA, USA Carl D. Regillo Wills Eye Hospital, Thomas Jefferson University, Mid Atlantic Retina, Philadelphia, PA, USA Dante J. Pieramici California Retina Consultants, California Retina Research Foundation, Retina Consultants of America, Santa Barbara, CA, USA
Präsentationsform	ePoster
Themengebiete	Retina Vitreous
Abstract-Text	Purpose PDS is the only refillable, continuous drug delivery system – approximately the size of a grain of rice – that has shown positive phase 3 data across 3 different indications (nAMD, DME, and DR) with just 1–2 refill-exchanges per year. PDS provides confidence for long-term vision and anatomical outcomes through continuous delivery of ranibizumab, now with >5 years of efficacy experience and surgical learnings. PDS is overwhelmingly preferred by patients to replace frequent intravitreal injections of anti-VEGF monotherapy. In October 2022, Roche/Genentech voluntarily recalled the PDS ocular implant and insertion tool assembly after identifying that implants did not meet prespecified performance standards. This presentation updates the Retina Community on significant manufacturing process improvements, resulting in improved septum durability that exceeds prespecified performance specifications. Methods Manufacturing process improvements to the implant and refill-exchange needle, and new quality controls have been implemented to ensure septum integrity of every implant manufactured, and to reduce the force required to insert the refill needle into the implant. Laboratory performance testing was conducted to characterize the bond strength of septum to the overmold, the force of needle puncturing the septum, and long-term septum performance. To simulate long-term clinical use, implants were aged at elevated temperature in saline and the septum repetitively punctured at random locations using the refill-exchange needle every 3.5 days to simulate multiple refill-exchange procedures. Results Manufacturing improvements to the refill-exchange needle reduces the force required to insert the needle into the septum by more than 50% (from 1N to 0.4N). Implant manufacturing improvements double the bond strength between the overmold and septum (from 1.2N to 2.4N), and together with refill-exchange needle improvements, increases septum survival from 50% to 100% at 10 years of simulated use, with no septum dislodgements observed. Laboratory performance data correlates with clinical experience with implants, validating the test methodology. Conclusion Manufacturing improvements to the implant and refill needle are collectively expected to ensure that PDS exceeds performance specifications and mitigates the risk of septum dislodgement. New implantations in the global clinical trials of the Port Delivery Platform are expected to resume by the end of 2023.