Margaret Chang, MD: Two-Year Outcomes of the PDS for Diabetic Retinopathy

Long-term results from the Phase 3 Pavilion trial showed the continued efficacy and safety of the Port Delivery System (PDS) with ranibizumab for continuous treatment in diabetic retinopathy (DR).

These 2-year data, presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting, supported the primary analysis, with continued improvement in the DR severity score (DRSS) from baseline and consistent safety data with no new safety signs observed through Week 100.

“Having some sustained delivery options, I think is really going to improve long-term outcomes, not only for neovascular age-related macular degeneration (nAMD), but for these diabetic patients, patients with diabetic macular edema (DME) and DR,” presenting investigator Margaret Chang, MD, MS, Retinal Consultants Medical Group, told HCPLive. “I think that the promise of the PDS is that it is a platform.”

PDS is a drug delivery system with a refillable ocular implant for continuous ranibizumab delivery. Pavilion assessed the PDS with fixed 100 mg/mL refill-exchange procedures every 36 weeks (Q36W) in patients with DR.

The trial achieved its primary endpoint, with superiority to clinical monitoring in ≥2-step DR severity score (DRSS) improvement from baseline at Week 52 (80.1% vs. 9.0%, respectively). These Year 2 data focus on long-term results through 100 weeks of PDS treatment.

In Pavilion, patients were randomized 5:3 to PDS Q36W or control. The first cohort received 2 ranibizumab 0.5 mg loading doses before PDS implantation at Week 4; the control arm received standard-of-care until Week 60 and 2 ranibizumab loading doses before PDS implantation at Week 64.

Patients in both cohorts could receive supplemental ranibizumab 0.5 mg treatment at each study visit, except refill exchanges.

In the PDS Q36W cohort (n = 106), approximately 80% (95% CI, 72.6–87.8) of patients achieved a ≥2-step DRSS improvement from baseline at Week 100. Across Week 100, only 2% of patients in the PDS Q36W cohort received supplemental treatment.

In the control arm (n = 29), 91.7% (95% CI, 80.6–100.0) of the implanted patients achieved ≥2-step DRSS improvement at Week 100. There were no patients in the implanted control arm who received supplemental treatment after PDS implantation.

Safety data revealed a consistent profile with the primary analysis, with zero cases of endophthalmitis reported up to one year and a rate of 0.8% through week 100. A single participant with DR developed endophthalmitis but continued to receive PDS with ranibizumab treatment refill exchanges after a successful resolution.

No endophthalmitis events were identified in implanted control arm patients after PDS implantation. No device dislocation events were reported in either arm through Week 100.

“I think that any options that we have for patients to not get monthly or bimonthly injections is going to be an important player in the future,” Chang told HCPLive.

Disclosures: Relevant disclosures for Chang include Astellas, Genentech, Opthea, RegenXBio, and others.

Reference

_{Chang M. Port Delivery System With Ranibizumab for Continuous Treatment in Diabetic Retinopathy: First Readout of 2-Year Data From the Phase 3 Pavilion Trial. Paper presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting. Stockholm, Sweden. July 17-20, 2024.}