Carl C. Awh, MD: Two-Year Outcomes of the Port Delivery System for DME

Two-year results from the Phase 3 Pagoda trial showed sustained efficacy and no new safety concerns for the Port Delivery System (PDS) with ranibizumab in treating center-involved diabetic macular edema (DME).

These data, presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting, suggested PDS with every-6-month refill exchanges provide long-term functional and anatomical benefits in DME care.

“Although the primary endpoint was met, what we showed is that after one more year, patients continue to maintain both the vision and anatomic benefits seen at one year,” presenting investigator Carl C. Awh, MD, Tennessee Retina told HCPLive.

PDS is an innovative drug delivery system utilizing a refillable ocular implant for continuous delivery of a customized formulation of ranibizumab. Susvimo (ranibizumab 100 mg/mL) was recently re-introduced for neovascular (wet) age-related macular degeneration (nAMD), marking the end of a voluntary recall.

An ongoing Phase 3, multi-center, randomized trial, Pagoda evaluated the efficacy, safety, and pharmacokinetics of the PDS with fixed 100 mg/mL refill-exchange procedures every 24 weeks (Q24W), compared with monthly ranibizumab, in patients with center-involved DME.

The trial met its primary endpoint, with PDS Q24W non-inferior to 0.5 mg intravitreal ranibizumab injections Q4W for best-corrected visual acuity (BCVA) change from baseline averaged over Weeks 60/64 (difference, 0.2 letters; 95% CI, –1.2 to 1.6).

Implantation in the PDS Q24W cohort occurred at Week 16— monthly ranibizumab patients received the PDS implant at Week 64 (implanted control arm). After implantation in both arms, PDS refill exchanges occurred Q24W through Week 112.

Across the efficacy population, BCVA was maintained through Week 112 in the PDS Q24W (n = 381) and implanted control (n = 207) arms. The adjusted change from the baseline was +9.8 and +9.3 letters, respectively, in the arms.

Optical coherence tomography (OCT)-measured central subfield thickness (CST) reduction was additionally sustained through Week 112 in each cohort. More than 95% of assessed patients did not receive supplemental treatment during the refill-exchange interval.

Until Week 112, safety data showed the rates of endophthalmitis were 0.6% and 0.8%, respectively, in the PDS Q24W (n = 320) and implanted control arm safety populations (n = 236). There were no new safety signals identified across either arm.

Watch the full interview with Awh to gain more insight into how these data supported the primary analysis, with PDS Q24W demonstrating continuous efficacy for more than 2 years.

Disclosures: Relevant disclosures for Awh include Bausch + Lomb, Genentech, and Katalyst.

Reference

_{Awh CC. Port Delivery System With Ranibizumab for Continuous Treatment of Diabetic Macular Edema: First Readout of the Phase 3 Pagoda Trial Year 2 Results. Paper presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting. Stockholm, Sweden. July 17-20, 2024.}