NOVEL OPHTHALMIC DRUG DELIVERY VEHICLES

DESCRIPTION (provided by applicant): The primary goal of this proposal is to develop a novel, liposome-based platform for enhanced ophthalmic drug delivery. The specific aims include the optimization of the present delivery platform in order to boost intraocular drug concentration and drug retention. Following the physical and chemical characterization of all new formulations, those formulations which possess the most desirable characteristics (i.e. physical and chemical stability and sterility) will be used in an ex vivo model to examine whether they enhance drug absorption in the cornea. The formulations that most significantly increase corneal drug absorption will be chosen for in vivo pharmacokinetic and biodistribution analysis. Candidates which successfully increase the intraocular drug concentration and drug residence time will be chosen for commercial product development using the proprietary manufacturing technology belonging to OPTIME Therapeutics, Inc. Diclofenac is the drug model which is being used to develop this platform, but the platform will be able to accommodate any drug molecule of moderate to extreme lipophilicity. Potential uses for such an ophthalmic drug delivery platform primarily involve the treatment of intraocular diseases or disorders, but may also be used in conditions where the exterior ocular surface is affected. PROPOSED COMMERCIAL APPLICATION: This liposome-based drug delivery platform could be used commercially in patients to reduce inflammation due to seasonal or bacterial conjunctivitis, to reduce post-surgical pain and inflammation, to prevent or treat fungal or bacterial infections of the eye, to treat herpes ophthalmicus, to reduce intraocular pressure, or to treat endophthalmitis. Additionally, such a drug delivery platform could be used to deliver drugs prior to a routine eye examination, or eye surgery.