CHAPTER 4: Sustained Delivery of Ocular Protein Therapeutics

Neovascular age-related macular degeneration (nAMD) is the leading cause of blindness in older adults in the United States and is primarily driven by vascular endothelial growth factor A (VEGF-A). While currently approved anti-VEGF therapies have revolutionized the treatment of nAMD, they require frequent intravitreal injections to maintain vision. This dosing regimen creates an enormous treatment burden on patients, thereby leading to less overall patient adherence and sub-optimal outcomes in the real-world setting. Therefore, there is a current unmet need for durable anti-VEGF treatments. The Port Delivery System with ranibizumab (PDS) is an investigational, innovative technological advance that enables continuous delivery of a customized formulation of ranibizumab to optimize visual outcomes while reducing the treatment burden. Here, we highlight the development of the Port Delivery System, long-term stability of ocular therapeutics, and their suitability for the Port Delivery System, as well as preclinical and clinical studies leading to first-in-human validation of this transformative delivery modality. The PDS may offer flexibility and options for prolonged treatment intervals in ophthalmology.