Archway demonstrates PDS outcomes equivalent to ranibizumab
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Phase 3 results of the Archway trial show patients with neovascular age-related macular degeneration treated with the Port Delivery System with ranibizumab experienced equivalent vision outcomes compared with patients treated with ranibizumab.
“The Archway trial met its primary endpoint with the PDS demonstrating equivalent efficacy and reduced treatment burden compared with the gold standard of monthly injections of ranibizumab. The PDS surgery/device/drug combination was generally well tolerated and had a favorable benefit-risk profile,” Peter A. Campochiaro, MD, said at the virtual American Society of Retina Specialists meeting.
The outcomes were obtained with 98% of patients in the PDS arm not receiving any other treatment than the PDS, which is critical for a sustained delivery approach, Campochiaro said in discussion of the study.
The Archway phase 3 trial included a total of 248 patients who received Genentech’s Port Delivery System (PDS) implant with refills of 100 mg/mL ranibizumab at fixed 24-week intervals compared with 167 patients who received monthly intravitreal injections of 0.5 mg ranibizumab.
Campochiaro and colleagues evaluated the change in best corrected visual acuity (BCVA) from baseline averaged over weeks 36 and 40 as the trial’s primary endpoint.
At baseline, patients had a mean BCVA of 74.8 letters, a 20/32 equivalent, and had received a mean of five prior anti-VEGF injections. Averaged over weeks 36 and 40, patients in the PDS cohort gained 0.2 letters compared with 0.5 letters in the ranibizumab cohort, a noninferior and equivalent outcome, Campochiaro said.
In the PDS cohort, patients experienced a transient surgery-related reduction of BCVA that returned to baseline levels by week 12 and was similar to the ranibizumab arm thereafter. Change in center point thickness at week 36 in the PDS cohort was +5.4 µm compared with +2.6 µm in the ranibizumab cohort.
Campochiaro noted approximately 98% of PDS patient did not receive a supplemental ranibizumab injection prior to the first refill exchange at week 24 and data for the second refill exchange is ongoing. Through week 40, the total mean number of treatments including implantation, refill and supplemental injections was two in the PDS arm compared with 10.7 in ranibizumab arm, he said.
Systemic safety findings were comparable between the two treatment arms, he said.
“Since approval of ranibizumab in 2006, new treatments have provided incremental benefits. The PDS is the first new treatment that provides a paradigm shift in the management of neovascular AMD,” he said.
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Campochiaro PA. Primary analysis results of the phase 3 Archway trial of the Port Delivery System with ranibizumab (PDS) for patients with neovascular AMD. Presented at: American Society of Retina Specialists annual meeting; July 24-26, 2020 (virtual meeting).
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