EyeLab Group proposes to continue research and development of a sustained time-release medication delivery insert for the eye. A device with a small reservoir will be placed in the lacrimal punctum in the upper lid, a minor tear drainage pathway, and deliver its medication(s) onto the surface of the eye. Its advantages are a degree of therapeutic assurance not possible with the standard ophthalmic drug formulation eye drops. First, delivery of the medication is assured, eliminating the compliance problem, the foremost concern in medical management of diseases requiring continuing use of medications, like glaucoma, a major cause of blindness in the United States. Second, the required medication concentration inside the eye is assured, eliminating both the initial peak concentration after an eye drop is instilled and the decrease over time, which can result in inadequate control in diseases like glaucoma. Third, by minimizing the amount of drug used, the risk of systemic side effects will be reduced. The research design aims to demonstrate in prototypes feasibility for controlling intraocular pressure in human volunteer patients with the diagnosis of open angle glaucoma or ocular hypertension by this novel route of drug delivery, and to initiate steps to commercialization.
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