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 4 million Americans. Aciont has completed all necessary preclinical GLP safety, proof-of-concept work in uveitis and manufacturing of our dexamethasone sodium phosphate (""""""""DSP"""""""") Visulex system needed to satisfy the FDA's requirements to test our proposed treatment in man. There are 3 specific aims for our research plan: """""""" Aim1-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. """""""" Aim2-Phase II Clinical Study (efficacy in uveitis). Demonstrate that our non-invasive DSP Visulex treatment is both safe and effective in treating uveitis. """""""" Aim3-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 doctor's office within 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 IIb SBIR proposes to develop a non-invasive ocular drug delivery system allowing for a simple, timely (potentially 5 minutes or less) application of a device (resembling a scleral lens) which can be performed by a nurse or paraprofessional in the doctor'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.