Non-Invasive Treatment for Uveitis

DESCRIPTION provided by applicant The aim of this innovative proposal is to commercialize a non invasive topical product that treats uveitis which is safe and easy to administer Uveitis is the third leading cause of blindness in the United States Heretofore the primary treatment of intermediate and posterior uveitis has been 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 uveitis The same product could be used to treat other indications such as diabetic macular edema a substantial market involving more than million Americans Aciont has completed all necessary preclinical GLP safety proof of concept work in uveitis and manufacturing of our dexamethasone sodium phosphate andquot DSPandquot Visulex system needed to satisfy the FDAandapos s requirements to test our proposed treatment in man There are specific aims for our research plan andquot Aim Phase I Clinical Study safety of treatment modality Demonstrate that our new drug delivery applicator and DSP formulations are safe and well tolerated in man andquot Aim Phase II Clinical Study efficacy in uveitis Demonstrate that our non invasive DSP Visulex treatment is both safe and effective in treating uveitis andquot Aim Optimize Visulex P System Design and Manufacturability of Components and Formulations Potentially our approach can lead to a non invasive drug delivery system that allows for a very simple treatment which can be performed by a nurse or paraprofessional in the doctorandapos s office within a range of 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 PUBLIC HEALTH RELEVANCE Our phase IIb SBIR proposes to develop a non invasive ocular drug delivery system allowing for a simple timely potentially minutes or less application of a device resembling a scleral lens which can be performed by a nurse or paraprofessional in the doctorandapos s office Such a system could curtail a significant portion of the acute sight threatening condition of severe uveitis in a single treatment while eliminating the need for risky and highly uncomfortable procedures such as injections into the center of the eye