Patients with wet AMD who participated in Genentech’s phase 3 ARCHWAY trial strongly preferred the PDS sustained-release implant over regular injections of ranibizumab. More than 93% of the 228 patients who received the implant cited such reasons as fewer injections, reduced discomfort, and less nervousness and apprehension. All of the patients in the trial had been previously treated with anti-VEGF injections.
Patients in the trial who did not receive the PDS had an average of 10 injections over 40 weeks, while those with the implant had only the initial implantation in the operating room and a mandated in-office refill at 24 weeks. Only 4 of 228 patients required a PDS refill prior to 24 weeks.
At AAO Virtual 2020, Nancy Holekamp, MD, reported that the PDS with a custom formulation of ranibizumab provided essentially the same efficacy as monthly injections of regular ranibizumab. Vision and retinal thickness were both maintained with the PDS at basically the same level as with regular ranibizumab, although there was a wider variety of mild adverse events associated with the surgical procedure. The PDS is also currently in the phase 3 PAVILION trial for diabetic retinopathy and the phase 3 PAGODA trial for diabetic macular edema.