Using a unique polymer matrix, tailored to the chemistry of the drug, timolol, and molded into an ocular insert in a design compatible with the conjunctival sac, we will affect the release of drug for the treatment of glaucoma over a 30 to 90 day period. Customizing a matrix with such specific chemistry is an innovative approach to ocular inserts. The long duration of release at constant rates achieved via this approach, as evidenced by Phase I in vitro results, represents a significant advance in the field and will have implications on efforts at many companies and institutions working towards extended release of drugs in ophthalmology. In Phase II we intend to show feasibility of the insert design in humans, as well as measure drug release rates in an animal model. Concurrently, we will develop a molding process similar to that used in contact lens manufacture. Efforts will be coordinated in three key fields: material development and chemistry, design and process engineering and clinical/biological studies.
The specific aims are:1. Produce ocular insert material containing 1.0 percent to 5.0 percent timolol and determine the release kinetics over this concentration range from test samples.2. Develop a cast molding, photopolymerization process and produce """"""""small"""""""" and """"""""medium"""""""" size inserts.3. Demonstrate the safety of the ocular insert material (non-drug loaded) utilizing both in vitro and in vivo testing.4. Determine the comfort and stability of the ocular insert (non-drug loaded) in a selected patient clinical study utilizing both the """"""""small"""""""" and """"""""medium"""""""" size inserts.5. Determine the in vivo release characteristics of the timolol-containing ocular insert in the rabbit model.6. Develop a business plan that will be presented to potential corporate partners to secure Phase Il funding.
