Andres Emanuelli, MD: Analysis of the Port Delivery System in the Phase 3 Pavilion Trial

Video

At ARVO 2023, Emanuelli discusses the primary analysis results of the phase 3 Pavilion trial evaluating the PDS with ranibizumab in patients with diabetic retinopathy without center-involved diabetic macular edema.

The majority of patients with diabetic retinopathy (DR) without center-involved macular edema experienced clinical benefits after implantation of the Port Delivery System (PDS) with ranibizumab, according to primary analysis results of the phase 3 Pavilion trial.1

The data suggest vision was maintained and the investigative team noted a trend in improvement in macular thickness in patients, with no new safety signals and no cases of endophthalmitis related to the implant.

“It was very encouraging, the Pavilion trial demonstrated that 80% of the patients that were in the Susvimo arm, they decreased ≥2-steps in the Diabetic Retinopathy Severity Scale (DRSS) score,” Andres Emanuelli, MD told HCPLive at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. “So, it was very encouraging when compared to only 9% in the control arm.”

A leading cause of vision loss in working-age adults, there is an unmet need for treatment strategies in DR that sustain the treatment benefit of anti-VEGFs and reduce the overall treatment burden. The PDS with ranibizumab is an innovative, continuous drug delivery system delivering a customized formulation of ranibizumab into the vitreous that is being evaluated for patients with DR.

Previously, the US Food and Drug Association (FDA) approved the PDS with ranibizumab for the treatment of neovascular age-related macular degeneration (nAMD) in October 2021.2 However, he PDS with ranibizumab ocular implant and insertion tool was voluntarily recalled by Genentech in October 2022 in the US, after testing of their commercial supply showed that some implants did not perform to the company’s standards.3

The phase 3 Pavilion trial evaluated the efficacy, safety, and pharmacokinetics of PDS 100 mg/mL with refill exchanges every 36 weeks (Q36W) in patients with DR without center-involved diabetic macular edema (DME). The ongoing, multicenter, randomized, visual assessor–masked trial randomized eligible patients (5:3) to the PDS Q36W arm (n = ~100) or the clinical observation arm (n = ~60), respectively.

Eligible patients were aged ≥18 years, with moderately severe or severe nonproliferative DR (Early Treatment Diabetic Retinopathy Study [ETDRS] Diabetic Retinopathy Severity Scale [DRSS] level 47 or 53) and were DR-treatment naive in the study eye. Inclusion criteria further included the diagnosis of diabetes, glycosylated hemoglobin ≤12%, and best-corrected visual acuity (BCVA) of ≥69 ETDRS letters. The prespecified primary endpoint in the Pavilion trial was the proportion of patients with a ≥2-step improvement from baseline on the ETDRS-DRSS at week 52.

For more insight into the analysis of the Pavilion trial, watch our interview with Emanuelli above.

Disclosures: Andres Emanuelli, MD reports having received financial support and consultant fees from Novartis, Regeneron Pharmaceuticals, Roche/Genentech, Apellis, and others.

References

  1. Emanuelli A, Holehamp NM, Latkany P, Brittain C, Howard D, Santhanakrishnan A, Wetzel-Smith M, Quezada-Ruiz C, Malhotra V, Pieramici DJ. Port delivery system with ranibizumab in the treatment of diabetic retinopathy without center-involved diabetic macular edema: primary analysis results of the phase 3 Pavilion trial. Presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting; April 2023; New Orleans, LA.
  2. Kunzmann K. FDA approves port delivery system with ranibizumab for WET AMD. HCP Live. https://www.hcplive.com/view/fda-approves-port-delivery-system-ranibizumab-wet-amd. Published October 22, 2021. Accessed May 2, 2023.
  3. Hutton D, Charters L. Genentech recalling ranibizumab injection ocular implant in US. Ophthalmology Times. https://www.ophthalmologytimes.com/view/genentech-recalling-ranibizumab-injection-ocular-implant-in-us. Published October 18, 2022. Accessed May 2, 2023.
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