The Port Delivery System with ranibizumab—journey of mitigating vitreous hemorrhage
Ashish Sharma, Nikulaa Parachuri, Nilesh Kumar, Baruch D. Kuppermann, Francesco Bandello
Abstract
There is a lot of excitement surrounding the novel sustained anti-vascular endothelial growth factor (anti-VEGF) drug delivery system named Port Delivery System with ranibizumab (PDS, Roche/ Genentech Inc., San Francisco, CA) that could address the major unmet need of reducing injection burden in various retinal diseases such as neovascular age-related macular degeneration, diabetic macular edema and diabetic retinopathy (DR) The United States-food and drug administration has recently (October 22, 2021) approved PDS with ranibizumab for clinical use The PDS has gone through 3 clinical trial phases (Phase 1, Phase 2 LADDER, and Phase 3 ARCHWAY) One of the major roadblocks during the initial stages of the trial was the occurrence of vitreous hemorrhage in a significant number of cases. This manuscript will highlight the journey of mitigation of vitreous hemorrhage (VH) from Phase 1 to Phase 3.