Clinical Report: The Port Delivery System in the Paradigm

Overview

The Port Delivery System (PDS) with ranibizumab offers a continuous drug delivery option for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), demonstrating noninferior efficacy compared to traditional monthly injections. Recent studies indicate that PDS significantly reduces treatment burden while maintaining vision improvements over extended periods. The PDS was approved by the FDA for nAMD in 2021 and for DME in 2025.

Background

Neovascular age-related macular degeneration (nAMD) and center-involving diabetic macular edema (CI-DME) are leading causes of vision loss, traditionally treated with frequent intravitreal anti-VEGF injections. The Port Delivery System (PDS) represents a novel approach by providing sustained drug delivery, potentially improving patient adherence and outcomes. Understanding the implications of this technology is crucial for optimizing treatment strategies in retinal disease management.

Data Highlights

Key Findings

• The PDS was approved by the FDA for nAMD in 2021 and for DME in 2025.
• Approximately 95% of PDS patients did not require supplemental ranibizumab treatment in the Archway trial.
• Adverse events associated with PDS are manageable and expected to decrease with improved surgical techniques.
• In the Pavilion study, 98% of PDS patients did not need supplemental injections.
• The PDS offers a significant reduction in treatment burden compared to standard injection protocols.

Clinical Implications

The introduction of the PDS may transform treatment paradigms for nAMD and DME by reducing the frequency of injections required, thereby enhancing patient quality of life. Clinicians should consider the PDS as a viable option for patients who have previously responded to anti-VEGF therapy, particularly those struggling with the burden of frequent injections, including those with poor adherence.

Conclusion

The Port Delivery System represents a significant advancement in the management of retinal diseases, offering sustained drug delivery with reduced treatment frequency. Its integration into clinical practice may improve patient outcomes and adherence to therapy, especially as new therapies emerge.

References

1. Genentech, Press Releases, 2025 -- FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness
2. Archway Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration 2-Year Results, PubMed, 2023 -- Archway Phase 3 Trial Results
3. AAO Age-Related Macular Degeneration Guideline Summary - Guideline Central, 2025 -- AAO Guidelines for AMD
4. Retinal Physician, 2025 -- Port Delivery System Sustains nAMD Control Over 5 Years
5. Retinal Physician — Inventory Systems Keep Track of Injectables
6. Techniques in Coloproctology — Robotic Approach to Total Proctocolectomy Utilizing the Da Vinci Si System: The P-STARR Method
7. Retinal Physician — Port Delivery System Sustains nAMD Control Over 5 Years
8. Retinal Physician - Inventory Systems Keep Track of Injectables
9. AAO Age-Related Macular Degeneration Guideline Summary - Guideline Central
10. Archway Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration 2-Year Results - PubMed
11. Genentech: Press Releases | FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness