Key clinical pearls for evaluating surgical candidates, and patient preference, for the Port Delivery System with ranibizumab (PDS)

Abstract

Purpose : The PDS is a US Food and Drug Administration–approved drug delivery system that includes a refillable ocular implant for continuous delivery of a customized formulation of ranibizumab, surgically implanted in the superotemporal quadrant at the pars plana. Key clinical pearls for preoperative evaluation of PDS surgical candidates and patient preference for the PDS versus intravitreal injection are reported.

Methods : The phase 3 Archway trial (NCT03677934) evaluated safety and efficacy of the PDS with ranibizumab 100 mg/mL with fixed 24-week refill-exchanges versus intravitreal ranibizumab 0.5 mg injections every 4 weeks in patients with neovascular age-related macular degeneration (nAMD). Treatment preference was assessed in the PDS arm at week 40 using the PDS Patient Preference Questionnaire.

Results : PDS candidates require careful preoperative evaluation, including thorough review of medical and surgical history to identify factors that may negatively affect conjunctival health and impact suitability for PDS implantation. History of prior conjunctival-based surgery may result in conjunctival scarring or poor tissue integrity. Long-term use of topical medications (eg, for glaucoma) may affect conjunctival quality, causing inflammation, scarring, and decreased thickness. Relevant ocular medical history, such as severe ocular surface disease, scleritis, or concomitant conditions, such as scleroderma, pemphigoid, or Sjogren’s syndrome, may also affect conjunctival or scleral integrity.
Examination of the conjunctiva and Tenon’s capsule should be performed preoperatively at the slit lamp with a cotton swab to assess mobility, scarring, and translucency/thickness. Eyelid health should be evaluated, with attention to lid hygiene, position, and mobility, which may impact postoperative infection risk and wound healing.
In Archway, 93.2% of PDS-treated patients (n = 234) preferred ranibizumab delivered via the PDS compared with intravitreal injection, with top reasons for preference identified as fewer treatments, less discomfort, and less worry/nervousness.

Conclusions : Careful preoperative evaluation is required to ensure optimal surgical outcomes for PDS candidates. PDS patients demonstrate a marked preference for the PDS over intravitreal injection; consistent attention to the clinical pearls described should help to maintain high levels of patient satisfaction.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.