SBIR Phase I: Hyaluronan-Based Ocular Delivery of Antibiotics

This Small Business Innovation Research Phase I project assesses the feasibility of using a novel synergistic drug-polymer ocular film product based on a modified biopolymer hydrogel to deliver antibiotics directly, locally and continuously to the ocular surface over an extended weekly period. This film combines the pro-healing, anti-inflammatory effects hyaluronic acid with slow release of an ophthalmic antibiotic. Topical ocular antibiotics require frequent dosing (i.e., hourly for corneal ulcers), often resulting in improper administration, causing suboptimal bioavailability to the eye and considerable waste. This novel polymer film can be placed on the ocular surface topically to deliver a well-known ophthalmic antibiotic. We propose to expand on known benefits of topical hydrogels by delivering antibiotics to reduce bacterial infections locally while simultaneously accelerating and improving healing. Prototype films of hydrogel containing antibiotics will be produced and evaluated for film degradation, anti-bacterial efficacy, and drug release. Safety and tolerability of the antibiotic-containing films will be demonstrated in a preclinical rabbit model. We anticipate being able to produce a well-tolerated antibiotic-releasing film product prototype and demonstrate the desired characteristics. Such a film would allow us to progress to a Phase II SBIR to optimize a sterile and clinically useful commercial product. The broader impact/commercial potential of this project is development of a new ocular drug delivery product that will improve patient care by providing a more efficient, effective, convenient, and consistent means of antibiotic delivery directly to the ocular surface. Using a known polymer carrier with intrinsic healing properties, this product will deliver continuous adequate doses locally, thus eliminating the frequent topical (up to every hour) and/or systemic doses of antibiotics for a wide range of infectious ophthalmic conditions. This improves patient compliance and patient outcomes, while reducing health care costs. Relevant eye diseases include active infections of the cornea and conjunctiva, as well as prevention of potential infections associated with various ocular surgeries and diseases. This topical extended release product addresses important unmet medical needs in the military and in civilian populations by providing healthcare provider-placed antibiotic product administered acutely. The antibiotic-containing films produced and evaluated in Phase I can ultimately lead to the development of a commercially viable ocular care product to address these unmet needs. Further, by demonstrating release of polybasic antibiotics, such a system could be expanded to deliver other antimicrobials to treat ophthalmic fungal or viral infections, which represent significant challenges in developing countries.