Few new adverse events reported with use of PDS in Archway follow-up
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WAILEA, Hawaii — Very few new adverse events related to the Port Delivery System device were seen in the 9 months following the primary endpoint of the Archway trial, according to a speaker here.
In 18-month follow-up data of the phase 3 trial of the PDS device (Genentech) with ranibizumab 100 mg/mL refilled every 24 weeks vs. ranibizumab 0.5 mg (Genentech) delivered intravitreally every 4 weeks, cataract was the most seen adverse event.
“Overall, up to 18 months, there is a slight imbalance: 8% in PDS; about 5% in intravitreal injections,” Carl D. Regillo, MD, said at Retina 2021.
Conjunctival issues of significance – erosion, retraction – occurred at about a 4.5% rate in the PDS group compared with none in the intravitreal injection group.
“Some of those did require surgery to repair,” Regillo said.
The endophthalmitis rate did not change past the primary endpoint, he said, with four cases in the PDS group (1.6%) and one case in the intravitreal injection group (0.6%).
Cases of vitreous hemorrhage, which were 6% in the PDS arm and 3.6% in the monthly arm, were all “relatively minor,” all resolved, and none needed surgery, Regillo said.
Of three implant dislocations, “they occurred for the most part at the time of refill exchange,” Regillo said. “We started to see them a little later in the course of the trial. We have identified some risk factors for that. And I will say right now, we have learned a lot from phase 2, phase 3 and beyond, from follow-up in terms of optimizing the surgical procedure to minimize hemorrhage, to minimize conjunctival issues and endophthalmitis, and to minimize implant dislocation.”
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Regillo CD. Sustained delivery of anti-VEGF for neovascular AMD. Presented at: Retina 2021; May 9-14, 2021; Wailea, Hawaii.
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