Drug delivery methods, structures, and compositions for nasolacrimal system

摘要

An implant for insertion into a punctum of a patient comprises a body. The body has a distal end, a proximal end, and an axis therebetween. The distal end of the body is insertable distally through the punctum into the canalicular lumen. The body comprises a therapeutic agent included within an agent matrix drug core. Exposure of the agent matrix to the tear fluid effects an effective therapeutic agent release into the tear fluid over a sustained period. The body has a sheath disposed over the agent matrix to inhibit release of the agent away from the proximal end. The body also has an outer surface configured to engage luminal wall tissues so as to inhibit expulsion when disposed therein. In specific embodiments, the agent matrix comprises a non-bioabsorbable polymer, for example silicone in a non-homogenous mixture with the agent.

主权项

1. A method of treating glaucoma of a patient with a punctal plug, the method comprising: placing the punctal plug in a lacrimal canaliculus of an eye, wherein the punctal plug comprises;
a silicone plug body comprising a drug insert; the drug insert comprising: a drug core comprising a therapeutic agent contained in a matrix; and an impermeable sheath body partially covering the drug core, wherein the sheath body is configured to provide an exposed proximal end of the drug core in direct contact with tear fluid that releases therapeutic agent to the eye when the drug insert is disposed within a channel of the punctal plug and the punctal plug is inserted into the lacrimal canaliculus of the patient; wherein the distal end of the drug insert is sealed with an adhesive, and wherein the method comprises delivering at least 10 ng per day of the therapeutic agent from the punctal plug to the eye of the patient for at least 21 days.