Intraocular Polymeric Drug Delivery Treatment for CMV

We will develop an injectable biodegradable biocompatible intraocular controlled-release drugdelivery system for the treatment of cytomegalovirus retinitis associated with AIDS. The antiviral drugis contained in biodegradable biocompatible polymeric microparticles, which are administered via syringeinto the vitreous of the patient by an ophthalmologist. Once in place in the vitreous, the microparticlesprovide a programmed controlled-release of the drug for a predetermined time interval, establishing atherapeutically effective drug concentration level. After delivering their drug load, the microparticlesdegrade into benign compounds that are readily absorbed by the body. In Phase I we will demonstratethe feasibility by 1. manufacturing controlled-release polymeric microparticles no larger than 50 microm with drug loads between 5 and 15wt%; 2. developing a delivery system with an average in vitrodrug release rate of approximately 1 microgram/h lasting at least one month. Phase II will focus onextending the time of delivery to achieve a balance among medical, technical, and marketing factors.Phase II will also include the accumulation of data to support an Investigational New Drug (IND)Application with the US Food and Drug Administration.