DRUG LOADED PUNCTUM PLUG FOR TREATMENT OF OCULAR DISEASE

In this Phase I proposal, we will investigate the loading and release of ocular drugs of importance into/from silicone punctual occlusion devices. The ultimate goal of the work (Phase I, II, and Ill) is to bring a drug loaded punctual occlusion device to the commercial medical device market, and to provide data that will support the claim that an occlusion device may be used as a temporary implant for the purpose of increasing the drug delivery efficiency for topical medications. Specifically, we aim to assist therapy of several ocular disorders and procedures, including dry eye syndromes, corneal graft/transplants, glaucoma, temporary increase in IOP following cataract or other ocular surgery, bacterial conjunctivitis, and corneal ulcers. In this Phase I study, we will evaluate the feasibility, methods, and kinetics of loading and release of five drugs of ocular importance from silicone punctual occlusion devices. The methods used to load these compounds into the substrate of the devices are proven methods previously studied by the investigators. These methods include three separate methods to incorporate pharmaceutical and therapeutic compounds into medical devices to ensure at least one suitable method for each drug compound will be identified. Collaboration with a world internationally recognized expert in ophthalmology will facilitate the animal studies, and greatly increase the impact of the study on commercially available medical devices used to treat ocular disorders.