SBIR Phase I: Multi-month, Nanoparticle Drug Delivery System For the Treatment of Glaucoma

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is embodied in the project's anticipated advance of the state-of-the art in controlled release technology, where there is a compelling need for sustained treatment in a range of medical conditions and diseases. The feasibility of the proposed technology has already been demonstrated in several other medical applications. For example, the technology has been demonstrated for coating intraocular lenses for cataract surgery to automatically deliver vital medications during the postoperative period. Likewise, the technology has been demonstrated in delivery of biologics that enhance wound healing for diabetic ulcers and bone healing after fracture. Other chronic and recalcitrant medical conditions and diseases that would benefit from long-term, controlled release include other ocular diseases (e.g., macular degeneration, chronic uveitis), cystic fibrosis, cancer, chronic pain, and more. Furthermore, it is also anticipated that the successful commercialization of this technology will motivate additional research and innovation in materials and nanofabrication for medicine. The proposed project will develop a multi-month, sustained release, biodegradable nanoparticle drug delivery system for treatment of eye diseases. At present, treatments for glaucoma and other ocular diseases rely on medication administered as topical eye drops. However, eye drops present significant limitations in efficiency and compliance among patients with daily drop regimens resulting in poor clinical outcomes. It is expected that the project will obviate the need for eye drops. The proposed technology is based on a proprietary layer-by-layer nanofabrication technique that enables assembly of drugs into an ultra-thin polymer coating. Drug coated nanoparticles are administered to the eye using a minimally invasive procedure. There the nanoparticles gradually degrade in the aqueous environment, releasing drugs directly to target tissue in a controlled and sustained manner. Vital medications are delivered locally within the eye improving bioavailability while requiring significantly decreased total dosage compared to eye drops. In Phase I the team will incorporate an existing FDA-approved drug into an LbL-assembled coating atop nanoparticle substrate cores. Extended release in vitro at therapeutically relevant drug concentrations will be demonstrated. The successful commercialization of this technology will significantly advance the state of the art in sustained release technologies and dramatically improve the standard of care for glaucoma patients.