435-P: Port Delivery System with Ranibizumab (PDS) in Diabetic Retinopathy (DR) with or without Diabetic Macular Edema (DME)

Abstract

DR, including DME, is a leading cause of preventable blindness in working-age adults, characterized by vascular instability and fluid leakage into the retina. Monthly intravitreal (ITV) injections with anti-vascular endothelial growth factor (VEGF; e.g., ranibizumab [RBZ]) have been FDA approved for maintenance/improvement of vision in DME since 2012. ITV anti-VEGF has also been approved for DR without DME. There is an unmet need for treatments that reduce treatment burden yet maintain the clinical benefits of monthly injections. PDS is an investigational drug delivery system for continuous delivery of RBZ into the vitreous. PDS 100 mg/mL with fixed Q24W refill-exchanges has been shown to be well tolerated and effective in neovascular AMD. Here we describe two phase 3 trials to evaluate PDS 100 mg/mL in DR/DME (Table). Pavilion (NCT04503551) will evaluate the prophylactic effects of PDS 100 mg/mL Q36W versus clinical observation in moderately severe-severe non-proliferative DR without DME. Pagoda (NCT04108156) will evaluate the tolerability of PDS 100 mg/mL Q24W and its efficacy versus ITV RBZ 0.5 mg Q4W injections in DME. Both trials will evaluate additional key endpoints (e.g., patient-reported outcomes). These trials will assess efficacy, safety, and tolerability of PDS 100 mg/mL, and its potential to provide clinical benefits in DR/DME, with reduced treatment burden.View largeDownload slideView largeDownload slide DisclosureM. Chang: Advisory Panel; Self; Genentech, Inc., Consultant; Self; Genentech, Inc. A. Bobbala: None. V. Malhotra: Employee; Self; Genentech, Inc., Employee; Spouse/Partner; Genentech, Inc. P. Latkany: Employee; Self; Genentech, Inc.