SBIR Phase II: Biodegradable Polymer Film for Sustained Delivery of Antibiotics to the Surface of the Eye

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be to more effectively treat serious, infectious corneal ulcers by delivering antibiotics directly to the eye?s surface via a novel, biodegradable flexible polymer film. The platform will deliver drug continuously, thereby eliminating the need for hourly eye drops. This product can be administered immediately, at time of injury, allowing health professionals to ensure best treatment and outcomes. The platform solves immediate unmet medical needs in corneal infections, which are a result of improper contact lens wear, as well as increased incidence of eye trauma in the US military. Worldwide, corneal ulcers commonly result in blindness due to difficulty in obtaining and applying medication. These antibiotic-containing films ? which combine polymer science, chemical bioengineering, and drug pharmaceutical formulation innovation ? will bring improved commercially available solutions to vision-threatening conditions far beyond corneal ulcers by employing this novel platform, which provides an effective, easy-to-administer, broad application of sustained, local ophthalmic drug delivery. Broader societal impact lies in the scientific and technical discoveries and innovation, as well as the ability to educate/train others on advances in polymer drug delivery science. The proposed product is based on a proprietary, cross-linked hyaluronic acid (HA) polymer technology, formulated with antibiotics to deliver drug locally and continuously to the ocular surface over multiple days. The well established healing effects of HA, combined with continual-release antibiotics create a novel product that fulfills a significant unmet medical need. Current topical ocular antibiotics require round-the-clock dosing. In addition to being inconvenient, if administered incorrectly, today?s eye drops can lead to continued eye trauma/damage, less-than-optimum outcomes, and considerable waste. The cross-linked, ?tunable? film ? applied by a medical professional ? contains a commercially proven antibiotic that is released over multiple days in precise quantities to the ocular surface with no further patient self-dosing required. In the grant?s Phase I, prototype HA films containing antibiotics were produced, sterilized, and successfully tested in vitro and in vivo for drug release and tolerability. Phase II will include shape development, formulation/drug-release optimization, drug content release confirmation in vivo, and development of a reliable manufacturing process for sterile shelf-stable films. The objective of this Phase II proposal is to continue to optimize and develop sterile antibiotic-releasing cross-linked HA films to be applied locally to the ocular surface to treat sight-threatening corneal ulcers.