Real-World Efficacy and Safety of the Ranibizumab Port-Delivery System in Neovascular AMD: First Time Two-Year Results of the SUMMIT Study

Document Type

Conference Proceeding

Publication Date

6-2025

Publication Title

Investigative Ophthalmology and Visual Science

Abstract

Purpose : FDA approved anti-VEGF therapeutic agents have transformed neovascular age-related macular degeneration (nAMD) treatment, but real-world evidence indicates a decrease in visual acuity over time due to injection frequency. The ranibizumab port-delivery system (PDS) was FDA approved for the treatment of nAMD in late 2021 to reduce injection frequency, alleviating patient burden. This real-world multi-center retrospective study collects and analyzes efficacy and safety of PDS as long-term agent in nAMD treatment.

Methods : This real-world multi-center retrospective study collects and analyzes efficacy and safety of PDS as long-term agent in nAMD treatment. Efficacy of PDS will be evaluated through changes in best corrected visual acuity (BCVA), the presence or absence of subretinal/intraretinal fluid (SRF/IRF), and central subfield thickness (CST) values via optical coherence tomography (OCT) scans. Average time to first refill and time between subsequent refills will be collected. Need for supplementary ranibizumab 0.5 mg injections will be recorded. Safety will be monitored through documentation of adverse events.

Results : A total of 46 eyes across 46 patients were recorded. The average age was 79.7 years, and 60.8% were female. Baseline is defined as the visit prior to the PDS implant and consecutive follow-up visits were collected. From baseline to the eighth follow-up (averaged 377.4 days) patients demonstrated an increase of 0.81 letters and a CST decrease of 10.47mm. Patients demonstrated an average of 258.84 days until first refill. One patient presented with active disease activity at one time point, and due to limited refill supply, the patient was given aflibercept once. 11/46 patients experienced surgery related adverse events. No cases of endophthalmitis or conjunctival retraction have been reported.

Conclusions : PDS is an innovative drug delivery system designed for sustained delivery of ranibizumab and has demonstrated excellent vision maintenance over 1 year. Patients demonstrated an average time to first refill of 8.2 months. Average CST has remained stable over study period. Future results will continue to investigate the long-term safety and efficacy of PDS in real-world patients with nAMD. First-time longer-term data will be presented at ARVO 2025.

Volume

66

Issue

8

First Page

4112

Comments

Association for Research in Vision and Ophthalmology ARVO Annual Meeting, May 4-8, 2025, Salt Lake City, UT

Last Page

4112

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