Archway meets all endpoints, could reduce treatment burden in nAMD
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Vision outcomes using a port delivery system proved equivalent to ranibizumab injections and showed a positive benefit profile, according to data presented at the virtual American Academy of Ophthalmology annual meeting.
These findings suggest that continuous delivery of ranibizumab by the port delivery system (PDS) could reduce treatment burden in patients with neovascular age-related macular degeneration (nAMD).
The PDS was designed to distribute an intravitreal delivery of ranibizumab via a surgical implant in the pars plana and refill exchanges.
“The primary objective was to evaluate both non-inferiority and equivalence of the PDS compared to monthly ranibizumab injections – baseline demographics and ocular characteristics were well balanced across the treatment arms,” Nancy M. Holekamp, MD, director of Retina Services at Pepose Vision Institute and professor of clinical ophthalmology at Washington University, said.
The phase 3 study, known as the Archway trial, included 415 patients diagnosed with nAMD within 9 months of screening and a previous response to anti-VEGF treatments. Investigators randomly assigned patients 3:2 to PDS with ranibizumab 100 mg/mL with 24-week refill-exchanges or intravitreal ranibizumab 0.5-mg injections every 4 weeks. Researchers measured the primary endpoint as change in BCVA score averaged over weeks 36 and 40.
“At week 36, the change from baseline was +5.4 microns in the PDS arm and +2.6 microns in the monthly ranibizumab arm. This was a prespecified secondary endpoint, as 98% of PDS treated patients did not receive supplemental treatment before the first refill exchange procedure at week 24,” Holekamp said.
She also reported that through week 44, PDS patients needed five times fewer treatments than patients who received monthly injections. This finding could help reduce treatment burden for patients and physicians.
The PDS implant insertion and refill-exchange procedures were generally well tolerated, with few adverse events. Fourteen of the 248 patients in the PDS arm (5.6%) experienced one or more significant ocular adverse events and one of the PDS-treated patients had irreversible vision loss, with systemic safety findings comparable across arms.
The trial met all endpoints, showing noninferiority and equal safety to monthly ranibizumab treatment. Additionally, patients reported a 93.2% preference to PDS over monthly treatments on a questionnaire, stating they experienced less worry, nervousness and discomfort. The positive patient feedback suggests that PDS could reduce treatment burden in nAMD.
“When we look at treatment burden, and the total number of ranibizumab treatments through week 40, we see that there are 10 monthly intravitreal ranibizumab injections, and only two ranibizumab treatments in the PDS arm. There were five times fewer treatments through week 44 PDS patients vs. monthly injections. In summary, PDS maintained vision while reducing treatment burden through continuous delivery of ranibizumab,” Holekamp said.
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Holekamp, NM. RET12.10. Presented at: American Academy of Ophthalmology Annual Meeting; Nov.13-15, 2020 (virtual meeting).
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