This article is part of Ophthalmology Advisor’s Focus on Retina coverage from the 2021 meeting of the American Academy of Ophthalmology, held in New Orleans from November 12 to 15, 2021. The team at Ophthalmology Advisor will be reporting on a variety of the research presented by the retinal experts at the AAO. Check back for more from the AAO 2021 Meeting.
A presentation covering The Archway Phase 3 trial (ClinicalTrials.gov Identifier: NCT03677934) demonstrates that continuous intraocular delivery of ranibizumab (Genentech) using the port delivery system (PDS) can help manage neovascular age-related macular degeneration (nAMD).1
Study results were presented by Mark Wieland, MD, and Jay Stewart, MD, at the American Academy of Ophthalmology 2021 meeting in New Orleans, held November 12-15. The trial shows both release and refill-exchange efficiency of this new system, and supports reliability of the ranibizumab PDS. Developed by a research team at the University of California, San Francisco, the grain-of-rice-sized permanent implant is placed in the superotemporal quadrant, and can be refilled in the clinic through a self-sealing septum.2
Archway is an interventional, randomized trial which enrolled 418 participants and took place from Sept. 12, 2018 to June 23, 2021. Further, ranibizumab was tested in vitro for various concentrations including 100 mg/mL, with investigators quantifying active release in μg per day, and how much medication remained in the implant.3 Results showed approximately 70% of the 100 mg/mL was discharged across 6 months, with no more detectable release after 450 days.1
The presenters reported that mean active release rate at 6 months were 3.95±0.17, 3.99±0.13, 3.85±0.15, and 4.00±0.17 μg/day at the initial fill, first, second and third refill-exchanges, respectively.1 Upon changing the concentration from 10 mg/mL to 100 mg/mL, initial medication release rate rose from approximately 2 μg to approximately 17 μg per day. Also, approximately 98% of the prior volume was replaced with new medication in a 100-μL refill.1 The proprietary needle used for refill-exchange has a dual cannula which can perform both tasks in a single stroke.3
PDS is typically covered by the upper eyelid, and was well tolerated in the Ladder phase 2 trial, with systemic safety similar to monthly ranibizumab injections.2 The phase 3, 24-week refill protocol also showed vision outcomes comparable with patients who underwent customary 4-week ranibizumab injections.2
The investigation concludes that PDS delivers ranibizumab reproducibly during several months with sustained effectiveness, and thus demonstrates the dependability of this system.1 Maintaining a schedule of only twice-per-year refills, the PDS offers an option which reduces a monthly injection burden to patients and their physicians.
Disclosures: This study authors have declared affiliations with the biotech and pharmaceutical industries. Please see the original reference for a full list of authors’ disclosures.
1. Wieland MR, Stewart JM. The port delivery system with ranibizumab: a new paradigm for long-acting retinal drug delivery. Paper presented at: The American Academy of Ophthalmology 2021 Annual Meeting; November 12-15; New Orleans. Abstract PA062.
2. Hering E. Port delivery system with ranibizumab (PDS) implant may revolutionize anti-VEGF therapy delivery. ARVO press release. Updated May 3, 2021. Accessed Nov. 6, 2021.
3. The Port Delivery System with ranibizumab (PDS)—a new paradigm for long-acting retinal drug delivery. ARVO Annual Meeting abstract. IOVS.ARVOJournals.org. https://iovs.arvojournals.org/article.aspx?articleid=2773028. Accessed Nov. 4, 2021.