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Presented at ASRS 2023, an analysis of the Portal trial suggests the efficacy and safety of PDS with ranibizumab was maintained over 5 years in patients with nAMD.
New results from the Portal 5-year subgroup analysis suggested the efficacy outcomes of the port delivery system with ranibizumab (PDS) were maintained over the long term in patients with neovascular age-related macular degeneration (nAMD).
The data, presented at the American Society of Retina Specialists (ASRS) 41st Annual Meeting, showed the maintenance of visual acuity, as the best-corrected visual acuity of 20/40 reported at enrollment in the phase 2 Ladder study was maintained over the next 5 years of study.
“It is exciting to see the sustainability durability and maintenance of good vision over a long period of time in these patients,” presenting investigator David J. Massop, MD, a retina specialist at Wolfe Eye Clinic, told HCPLive at ASRS 2023.
The PDS was approved by the US Food and Drug Administration (FDA) in October 2021, as a drug-device combination with 2 refills per year for the maintenance of vision and retinal anatomy in patients with nAMD. By October 2022, the PDS ocular implant, insertion tool assembly, drug vial, and initial fill needle were voluntarily recalled by Genentech/Roche, including in ongoing clinical trials. Refill-exchange procedures continued in eligible patients who already had an implant.
Portal is an ongoing, multicenter, open-label extension study enrolling patients who completed the Ladder or Archway studies. Patients in Ladder received the PDS (10, 40, or 100 mg/mL) with pro re nata (PRN) refills or monthly intravitreal ranibizumab 0.5 mg injections. After being rolled over to Portal, patients received PDS 100 mg/mL with fixed refill exchanges every 24 weeks from day 1.
Efficacy outcomes were assessed for Ladder-to-Portal patients treated with PDS 100 mg/mL for ≥5 years. Long-term safety data were pooled to include any patient in the 10, 40, and 100 mg/mL groups of Ladder who have had the PDS for ≥5 years.
The analysis showed the baseline BCVA of 20/40 Snellen was maintained over 5 years in the every 24-week PDS 100 mg/mL group, suggesting a demonstrated stability in these patients. In addition, central point thickness remained stable over the 60-month period in patients who received PDS 100 mg/mL every 24 weeks.
Regarding durability, patients were assessed for supplemental ranibizumab injection, based on pre-defined study criteria. In Ladder and Portal, approximately 95% of all Ladder-implanted patients did not receive supplemental treatment before each refill-exchange interval during Portal, indicating good durability at the 6-month internal.
Safety outcomes showed a total of 47 patients (41%) reported an adverse event of special interest, with 1 patient experiencing hyphema that was considered to be vision-threatening. Investigators noted PDS was generally well-tolerated over 5 years in the 114 patients that completed 5 years of treatment.
“With any surgery, there’s always concerns of safety, and specifically, there’s a concern for infection any time you put hardware in the body, including the eye,” Massop told HCPLive. “Of note, over this 5-year period, none of these eyes had endophthalmitis, but it’s certainly a risk of the procedure.
Dr. Massop reports no relevant financial disclosures.