Researchers have reported two-year data from the phase 3 Archway trial on the use of the Port Delivery System (PDS) with ranibizumab for the treatment of neovascular age-related macular degeneration (nAMD).
Give me some background on PDS with ranibizumab.
The PDS is an innovative ocular drug delivery designed to continuously deliver ranibizumab, an anti-vascular endothelial growth factor (anti-VEGF) formulation, to the retina over the course of at least 6 months. It’s the first long-acting ocular biologic drug delivery system that has demonstrated clinical safety and efficacy.
The system was approved by the FDA as the first drug-eluting implant called Susvimo (Genentech/Roche) in October 2021 for the treatment of nAMD in adult patients. There has been a subsequent voluntary recall in October 2022 of the implant and insertion tool assembly due to septum dislodgement for particular lots.
Talk about the Archway trial.
The randomized, multicenter, active-comparator controlled, open-label phase 3 trial was designed to evaluate the safety and efficacy of PDS with ranibizumab compared to an intravitreal injection in patients with nAMD.
A total of 418 patients were randomized 3:2 to receive either a PDS implantation with ranibizumab fixed refill-exchanges of 100 mg/ml for 6 months (n = 251), or a monthly intravitreal injection of 0.5 mg ranibizumab (n =167).
What were the initial results?
The study met its primary objective of change in best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score —which was non-inferiority margin,-4.5 letters; equivalence margin, ±4.5 letters)—while PDS demonstrated non-inferior and equivalent efficacy to ranibizumab injections.
Further, 98.4% of PDS-treated patients did not require supplemental treatment during the 6-month period.
What did the 2-year data measure?
The primary outcomes included BCVA ETDRS letter score from baseline averaged over Weeks 60 and 64 as well as Weeks 88 and 92 (noninferiority margin, –3.9 ETDRS letters).
And the results?
PDS was found to be non-inferior to monthly ranibizumab, with an adjusted mean change in BCVA score of +0.4 and –0.6 ETDRS letters. An average of 95% of PDS-treated patient did not require supplemental treatment
Any adverse events?
The most common adverse events (AEs) reported in both arms was cataract in PDS-treated patients (8.9%) and ranibizumab patients (6%); AEs in the PDS-treated arm included conjunctival erosions (4%), conjunctival retractions (2.4%), endophthalmitis (1.6%), and implant dislocations (1.6%).
Take away.
The 2-year data showed non-inferiority for PDS with ranibizumab, with results comparable to those achieved with ranibizumab injections (PDS used 2 refill-exchanges per year).
Significance?
According to experts, the potential for PDS to serve as a long-acting, continuous treatment for nAMD could significantly reduce the burden of anti-VEGF treatment for patients.