(652e) Development of a Controlled Release Platform for Topical Ocular Drug Delivery

One of the biggest problems facing patients with ocular diseases such as glaucoma and chronic dry eye is the frequent administration of medication via eye drops. For example, post-operative antibiotics following cataract surgery must be instilled as often as six times per day initially to prevent potentially blinding infection. The goal of this work is the proper administration of the correct amount of drug through the use of novel delivery systems and controlled drug release. This is achieved using a unique, topically gelling “eye drop”. The key to achieving controlled release of these drugs for the desired time frame, from days to months, is the use of degradable polymeric microspheres. The drug is encapsulated within the microspheres and predictably releases as the polymer chains hydrolyze in vivo . Our work in this area has included extensive in vitro characterization testing as well as large animal studies in glaucoma and antibiotic delivery. The drop itself is instilled in the same way as a traditional eye drop . Upon reaching a temperature of at least 34°C within the lower eyelid, the liquid gel sheds excess water and forms an opaque, stable, and nondegradable solid material. This gel is pliable and low volume, making it comfortable in the inferior fornix space, where the embedded polymer microspheres release drug for the period of time needed , allowing the drop to be wholly removed at any time by simply irrigating with room temperature saline. The purpose of this talk is to discuss the preclinical development and translational considerations for this biomaterials-based platform for ocular drug delivery with a focus on market size (large market vs. orphan drugs) and usage (acute vs. chronic).