Port Delivery System Trial Shows Strong Efficacy, Patient Preference

The Port Delivery System (PDS), a preloaded ranibizumab delivery device, has continued efficacy in the treatment of neovascular age-related macular degeneration after 2 years, according to a presentation delivered at the American Academy of Optometry 2022 meeting in San Diego, CA, held from October 26 to 29. The presenters of this research included Carolyn Majcher, OD, and Kay Smarzinski, OD. 

The PDS is an intraocular implant preloaded with 100 mg/mL of anti vascular endothelial growth factor (VEGF) ranibizumab. The drug is slowly released from the device over the course of 24 weeks. Patients implanted with this device are still eligible for supplementation with conventional injections.

The presentation reported the findings of the Archway trial (ClinicalTrials.gov Identifier: NCT03677934), which included 248 patients implanted with the PDS device and 167 patients managed with intravitreal ranibizumab 0.5 mg injections every 4 weeks for 2 years. 

The researchers found PDS replacements every 24 weeks provided outcomes comparable with monthly ranibizumab, and that approximately 95% of patients treated with the implant did not require supplemental ranibizumab injections. 

The trial also evaluated patient experiences with the Patient Preference Questionnaire at week 40. The findings show 93% of patients preferred the PDS to intravitreal injections due to fewer treatments, and less discomfort.

The FDA issued a boxed warning for the PDS due to its associated 3-fold higher endophthalmitis rate compared with intravitreal injections. In the trial, endophthalmitis cases were mostly associated with conjunctival retraction.

Researchers advise careful preoperative evaluation, including a thorough review of all medical and surgical history, before referring a patient for PDS implantation, since conjunctival-based surgery, or long-term use of topical medications (such as those used for glaucoma), may reduce the chances of achieving optimal outcomes.

“The PDS has potential to reduce high intravitreal treatment burden and improve real-world outcomes,” according to the presenters.