Many Americans suffer from ocular diseases which require application of topical therapeutic agents. These diseases range from bacterial conjunctivitis to intraocular inflammation. Keratoconjunctivitis sicca (dry eye) affects nearly 30 million people. Glaucoma affects 2 to 3 million Americans. Topical treatments exist but their ability to deliver drugs to the eye is minimal (<5%). The overall goal of this project is to develop a biocompatible, biodegradable ocular drug delivery system (Ocular Gel) using proprietary cellulosic/starch carboxylate copolymers. Ocular Gel will meet the need for sustained drug delivery in topical formulations for treating conditions ranging from glaucoma and inflammation to infection and dry eye. Many review articles have demonstrated the need for an ocular drug delivery system that provides long retention time, easy of use, high patient acceptance, and ease of manufacture. Ocular Gel would be formulated in combination with current topical ophthalmic drug preparations to provide an increased retention time which improves the bioavailability of the drugs and reduces the required dosing frequency. The unique aspect of Ocular Gel is the use of the physiologic properties of the eye (pH, temperature, and ionic strength) to transform a clear, fluid, topical application into a gelling matrix when placed in the eye. Specifically the work will encompass determining if Ocular Gel is non-irritating within both in vitro and in vivo testing as well as determining the extent that it increases the bioavailability of topically applied drugs. Biopolymer Innovations will optimize a prototype formulation in Phase I and conduct extensive pharmadynamic and pharmakinetic testing in Phase II with the guidance of a selected pharmaceutical company to ensure development of products that will meet their needs. The technology would remain Biopolymer Innovations and would be licensed to the larger pharmaceutical companies for their specific usage. There is a need for improved topical ocular drug delivery systems from both a therapeutic and a marketing perspective. Worldwide sales for ophthalmic drugs are projected to grow from 4.4B in 2000 to 8.6B in 2005. Future sales are projected to grow substantially in light of an aging population. Glaucoma alone is one of the leading causes of blindness in America. A stated goal of the National Eye Institute is to find more effective treatments for glaucoma. Ocular Gel has the potential to improve both the effectiveness of ophthalmic drugs and increase patient compliance, for glaucoma as well as many other ocular conditions.
