DEC 30, 2021
Archway is a phase 3 randomized, active-comparator, open-label, noninferiority study of the Port Delivery System (PDS) for neovascular age-related macular degeneration (nAMD) in patients who previously responded to anti-VEGF therapy.
A total of 418 patients were randomly assigned to receive either the PDS with ranibizumab 100 mg/mL and fixed 24-week refill-exchanges (PDS Q24W) or intravitreal injections of ranibizumab 0.5 mg every 4 weeks. The primary endpoint was change in best-corrected visual acuity (BCVA) score from baseline averaged over weeks 36 and 40.
The adjusted mean (standard error) change in BCVA score from baseline averaged during weeks 36 and 40 was +0.2 (0.5) ETDRS letters in the PDS Q24W arm and +0.5 (0.6) in the monthly ranibizumab arm (difference of –0.3 letters). Nearly all of the patients randomized to PDS Q24W did not need supplemental ranibizumab before the first 24-week refill-exchange procedure. The rate of ocular adverse events of special interest was greater in the PDS group than in the monthly ranibizumab group (19% vs. 6%); reported events included endophthalmitis, retinal detachments, vitreous hemorrhages, conjunctival erosions, and conjunctival retraction.
The study’s primary analysis was conducted using data through week 40, and thus encompassed only one complete refill-exchange interval. Future studies will be needed to assess the long-term performance and complication rate of the PDS. Additionally, since monthly monitoring was required for PDS-treated patients to align with the visit schedule of the patients given monthly ranibizumab, further research is required to investigate whether this device reduces the visit burden for patients.
The PDS was both noninferior and equivalent to monthly ranibizumab injections with regard to vision. For patients showing a preference for a surgical implant over office intravitreal injections, the PDS has the potential to help reduce the frequency of treatment visits and improve vision outcomes in patients with nAMD.