FLORetina 2025: Port delivery system shows reliable 6-month durability and sustained efficacy in neovascular AMD for up to 7 years

The results of the Portal extension trial of the Port Delivery System with ranibizumab (PDS) (Susvimo, Roche/Genentech) for age-related macular degeneration (AMD) showed sustained improvements in vision in 50% of patients out to 7 years after implantation of the device.

Carl D. Regillo, MD, FACS, Director of the Retina Service, Wills Eye Hospital, and Professor of Ophthalmology, Thomas Jefferson University, Philadelphia, reported the results at the 2025 FLOretina-ICOOR (International Congress on OCT Angiography, En Face OCT, and Advances in OCT) meeting in Florence, Italy, from December 4 to 7.

Portal study

The Portal extension trial [NCT03683251], which followed patients for 5 years, combined 100 patients from the Ladder-to-Portal phase II study [NCT02510794] and 352 patients from the Archway-to-Portal phase III study [NCT03677934] to evaluate the long-term outcomes of the PDS implant for AMD. The respective follow-up durations of the two studies were 274.8 weeks and 203.5 weeks. All patients underwent refill-exchange procedures of the PDS 100 mg/ml every 24 weeks, Dr. Regillo recounted.

The Ladder study evaluated three PDS doses of 10, 40, and 100 mg/ml administered via a pro re nata regimen compared with intravitreal injections of ranibizumab 0.5 mg (Lucentis, Genentech) administered every 4 weeks. Patients were followed for up to 7 years.

The Archway study evaluated PDS administered every 24 weeks compared with intravitreal injections of ranibizumab 0.5 mg. The patients were followed for 5 years.

Phase II Ladder trial and phase III Archway findings

Ladder study

The results showed that 50% of the patients in the Ladder trial who were implanted with the PDS with 100 mg/ml dosing maintained 20/40 vision for up to 7 years.

The investigators found that continuous delivery of ranibizumab via the PDS may preserve vision better than the standard-of-care intravitreal injections of ranibizumab over the long term. The mean decline in vision in the Ladder study was about two to seven letters over 7 years, which was in contrast to the extrapolated visual drop-offs in the CATT, HORIZON, and SEVEN-UP studies over 5, 5, and 7 years, respectively.

Continuous delivery of ranibizumab via the PDS also resulted in consistent anatomic control for up to 7 years.

In addition, the durability of the treatment was seen in 95% of patients across each refill-exchange interval.

Adverse events of special interest occurred in 42.1% of patients considered all 197 PDS implants; the endophthalmitis rate was 3.0%.

Archway study

Similar findings were seen in the Archway study, ie, half of the patients maintained better than 20/40 Snellen vision over 5 years; the vision lost was about 1.5 lines during the 5-year study period. This is in contrast to the CATT, HORIZON, and SEVEN-UP trials in which the visual decreases ranged from about 12 to 17 letters.

As in the Ladder study, continuous delivery of ranibizumab via the PDS resulted in consistent anatomic control for 5 years, and sustained durability of the PDS was maintained across each refill-exchange interval throughout the portal in about 95% of patients.

The endophthalmitis incidence was 2.6%.

In the Ladder and Archway studies, the endophthalmitis rates were similar to that associated with intravitreal injections for AMD. The incidence of infection dropped after 2020 when updated implantation measures were started.

“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,” Dr. Regillo commented.