Port delivery system: a novel drug delivery platform to treat retinal diseases

ABSTRACT

Introduction

Retinal disease treatment delivery is mostly limited to intravitreal injections and slow-release injectable implants due to structural barriers in the eye, and carry associated adverse effects and relatively high treatment burden. The Port Delivery System with ranibizumab (PDS) is a novel drug delivery device that is surgically implanted into the vitreous cavity and allows for continuous release of the anti-vascular endothelial growth factor (anti-VEGF) ranibizumab, eliminating the need for frequent intravitreal injections while maintaining therapeutic intraocular drug levels to control disease activity. Investigations of PDS are summarized in this review.

Areas covered

The most recent reported findings from preliminary studies and phase I–III trials are reviewed. We discuss the ramifications of these studies and the future potential for PDS in the treatment of retinal diseases.

Expert opinion

PDS is a novel drug delivery platform for the treatment of retinal diseases. Currently, the data from the PDS has shown promising efficacy and ability to substantially mitigate treatment burden while effectively generating visual and anatomic outcomes similar to those in patients receiving the standard monthly ranibizumab for neovascular age-related macular degeneration. Further studies are ongoing to investigate this novel drug delivery system in other disease states.

KEYWORDS:

• Age-related macular degeneration
• anti-vegf
• intravitreal injection
• macular edema
• neovascular
• portal delivery system
• ranibizumab

Article highlights

• Port Delivery System (PDS) is a novel implantable drug delivery device filled with ranibizumab that is placed in the operating room.

• Phase I-III trials have shown that PDS is relatively safe and effective at maintaining visual acuity and macular anatomy that is noninferior to what is seen with treatment with monthly ranibizumab injections.

• Pharmacokinetic data from aqueous humor and serum concentrations of ranibizumab show that PDS produces sustained levels of ranibizumab within the range of regular intravitreal injections, with fewer fluctuations.

• Standardization of the procedure of PDS implantation and refill exchanges has significantly reduced rates of adverse events that were observed in earlier phase clinical trials.

Declaration of interest

Arshad M. Khanani is a speaker for Genentech, Allergan, and Novartis; Consultant for Adverum, Aerpio, Allergan, Chengdu Kanghong, DORC, Genentech, Glaukos, Gyroscope, Gemini Therapeutics, Iveric Bio, Kodiak, Novartis, Opthea, Oxurion, Recens Medical, and Regenxbio; Received grant support from Adverum, Alkahest, Allergan, Chengdu Kanghong, Genentech, Gyroscope, Gemini Therapeutics, Kato Pharmaceuticals, Kodiak, NGM Biopharmaceuticals, Novartis, Iveric Bio, Opthea, Oxurion, Recens Medical, Roche, and Regenxbio. Christina Y. Weng is a consultant for Alcon, Allergan/AbbVie, Alimera Sciences, Novartis, Genentech, Regeneron, REGENXBIO, Dutch Ophthalmic Research Center (DORC). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.