Transscleral Pars Plana Choroid Ablation Using the Iridex Laser System Yields Improvements for Surgical Insertion of the Port Delivery Implant in a Minipig Model.

Purpose: To evaluate an alternative surgical approach for Port Delivery System with ranibizumab (PDS) implant and a novel application of Iridex laser system in Gottingen minipig model.

Methods: A total of seventeen male minipigs (Part 1: 9 animals in non-recovery and Part 2: 8 animals observed for 8-days post-surgery Part 2) received PDS implant insertion into each eye. The effect of Iridex 810 nm infrared diode laser with varying energy (power or duration) on transscleral pars plana ablation, surrounding ocular tissue and postsurgical vitreous hemorrhage (VH) was investigated.

Archway Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration 2-Year Results.

Purpose: To report 2-year results from the Archway clinical trial of the Port Delivery System with ranibizumab (PDS) for treatment of neovascular age-related macular degeneration (nAMD).

Design: Phase 3, randomized, multicenter, open-label, active-comparator-controlled trial.

Participants: Patients with previously treated nAMD diagnosed within 9 months of screening and responsive to anti-vascular endothelial growth factor therapy.

Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies.

Introduction And Objective: Serous retinopathy can be associated with MEK inhibitors, including cobimetinib. We present results of an integrated safety analysis to further characterize ocular functional and structural changes due to serous retinopathy.

Methods: Four studies evaluating cobimetinib at the approved dose and schedule in combination with other oncology drugs were included.

Management of Key Ocular Adverse Events in Patients Implanted with the Port Delivery System with Ranibizumab.

Purpose: To provide strategies for the management of key ocular adverse events (AEs) that may be encountered with the Port Delivery System with ranibizumab (PDS) in practice and provide recommendations that may mitigate such AEs based on clinical trial experiences and considerations from experts in the field.

Design: Safety evaluation based on the phase 2 Ladder (NCT02510794) and phase 3 Archway (NCT03677934) trials of the PDS.

Methods: The PDS implant is a permanent, indwelling, and refillable ocular drug delivery system that requires standardized procedural steps for its insertion and refill-exchange procedures, which evolved during the PDS clinical program.

Refill-Exchange Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Trial Experience.

Purpose: To describe the Port Delivery System with ranibizumab refill-exchange procedure.

Methods: Procedure based on the clinical trial program in patients with retinal diseases.

Results: The refill-exchange procedure is performed under topical anesthesia and strict aseptic conditions.