Port Delivery System Demonstrates 7-Year Vision Preservation in Wet AMD Patients
Key Insights
The Portal extension trial showed that 50% of patients with wet age-related macular degeneration (search) maintained 20/40 vision for up to 7 years using the Port Delivery System (search) with ranibizumab.
Continuous drug delivery via the implantable device resulted in minimal vision loss of only 2-7 letters over 7 years, significantly better than traditional injection regimens.
The system maintained 95% durability across refill-exchange intervals with reduced treatment burden, requiring refills only every 24 weeks.
The Port Delivery System (search) (PDS) with ranibizumab has demonstrated sustained vision preservation in patients with wet age-related macular degeneration (search) (AMD) for up to 7 years, according to results from the Portal extension trial presented at the 2025 FLOretina-ICOOR meeting in Florence, Italy. The findings represent the longest prospective study of wet AMD (search) patients ever performed and show significant advantages over traditional intravitreal injection regimens.
Seven-Year Vision Outcomes Show Remarkable Preservation
The Portal extension trial combined 100 patients from the phase II Ladder-to-Portal study and 352 patients from the phase III Archway-to-Portal study to evaluate long-term outcomes of the PDS implant. Carl D. Regillo, MD, FACS, Director of the Retina Service at Wills Eye Hospital (search), reported that 50% of patients implanted with the PDS 100 mg/ml dosing maintained 20/40 vision for up to 7 years.
"What matters to patients is keeping driving vision, and approximately half of those treated with PDS 100 mg/ml maintained 20/40 vision up to 7 years," said Arshad M. Khanani, MD, MA, FASRS, during his presentation at the Euretina congress.
The mean decline in vision over the 7-year period was remarkably minimal, ranging from only two to seven letters. This represents a significant improvement compared to extrapolated visual outcomes from landmark studies including CATT, HORIZON, and SEVEN-UP trials, where visual decreases ranged from approximately 12 to 17 letters over similar time periods.
Sustained Durability and Reduced Treatment Burden
The PDS demonstrated exceptional durability, with 95% of patients maintaining sustained effectiveness across each refill-exchange interval throughout the Portal study period. All patients underwent refill-exchange procedures every 24 weeks, dramatically reducing the treatment burden compared to monthly intravitreal injections.
"We are all aware that patients in the real world lose vision due to under treatment with injections due to treatment burden," Khanani explained. "This data from the port delivery system (search) shows much improved long-term vision outcomes while reducing treatment burden."
The system's predictable performance was particularly notable, with researchers finding that patients who initially required supplemental injections could be identified within the first 6 months, and those who didn't require supplemental treatment were unlikely to need it later in the treatment course.
Anatomic Control and Safety Profile
Continuous delivery of ranibizumab via the PDS resulted in consistent anatomic control throughout the study periods, with maintenance of central subfield thickness over time. The Ladder study followed patients for up to 7 years with follow-up duration of 274.8 weeks, while the Archway study followed patients for 5 years with 203.5 weeks of follow-up.
The safety analysis, based on 197 patients who received PDS implants, showed adverse events of special interest in 42.1% of patients. The endophthalmitis (search) rate was 3.0% in the Ladder study and 2.6% in the Archway study, similar to rates associated with intravitreal injections for AMD.
Importantly, the incidence of infection decreased after 2020 when updated implantation measures were implemented. "The current safety seen in clinical trials and real-world studies is much better with PDS compared to what was seen in Ladder," Khanani noted, attributing improvements to refined surgical techniques including better handling of the conjunctiva and Tenon's capsule, optimized wound size, and improved closure methods.
Clinical Implications for Long-Term AMD Management
The Portal extension trial results highlight the potential of sustained drug delivery to address the chronic nature of wet AMD (search) while reducing treatment burden. "We are optimizing the outcomes for our patients in the long term by giving them continuous delivery of ranibizumab with PDS," Khanani emphasized.
Dr. Regillo concluded that "The Ladder-to-Portal results align with those from Archway-to-Portal, over 7 and 5 years of follow-up, respectively, highlighting the potential of PDS treatment to deliver reliable 6-month durability with sustained efficacy outcomes for patients with nAMD over the long term."
This represents the first time prospective 7-year vision and anatomic data have been demonstrated in a clinical trial setting for wet AMD (search), potentially establishing a new paradigm for long-term management of this sight-threatening condition.