The overarching aim of this innovative proposal is to develop and then commercialize a non-invasive topical product which is safe and easy to administer that treats severe uveitis, including intermediate and posterior uveitis. Uveitis is the third leading cause of blindness in the United States. Heretofore, the primary treatments of intermediate and posterior uveitis are either oral medications (with significant systemic side effects) or invasive local methods, such as an intravitreal injection (IVT), periocular injection or implantation of a sustained release drug delivery device into the eye. Thus, there is a great need to develop a superior drug delivery system in terms of safety, patient acceptance and efficacy for severe uveitis. Our previous, successful SBIR phase I proposal (1 R43 EY014772-01) and subsequent studies gave us insights on the permeability of a water soluble corticosteroid to the eye globe;clearance effects of the conjunctiva and retina/choroid and the dosing requirements of dexamethasone sodium phosphate (DSP) to treat an in vivo IVT EIU rabbit model using a controlled release, passive diffusion-based methodology. The investigation of Aciont's vasoconstrictor technology, based on the principle of reducing the eye's blood flow clearance effects funded by that grant reached a successful endpoint. This proposal builds upon our prior SBIR work by advancing our technology closer toward commercialization into a viable product. The following main aims for this SBIR phase II proposal are closely related: 1) Complete Engineering of First Generation, Passive Diffusion Based Applicator/Device;2) Complete Formulation Development for a Single Unit Dose Treatment Protocol under an Acute, Severe Uveitis Disease Condition Model;3) Establish a Repeat Dose Treatment Protocol To Address a Chronic Uveitis Condition (i.e., Efficacy in Primate Model);and 4) Establish 28 Day Local Tolerance and Safety in a Chronic Uveitis Repeat Dose Treatment Protocol. Potentially, our approach can lead to a non-invasive delivery system that allows for a very simple treatment in the doctor's office which can be performed by a nurse or paraprofessional in a range of 5-10 minutes. Such a system has the potential to curtail a significant portion of the acute sight threatening condition of severe uveitis in a single treatment. A long term goal could be to train patients to administer our treatment system by themselves.
Our phase II SBIR proposes to develop a non-invasive ocular drug delivery system allowing for a simple, timely (potentially, 5 minutes or less) application procedure in the doctor's office of a device (resembling a scleral lens) which can be performed by a nurse or paraprofessional. Such a system could curtail a significant portion of an acute sight threatening condition of severe uveitis in a single treatment.
