| CPC A61K 9/0051 (2013.01) [A61F 9/0017 (2013.01); A61F 9/0026 (2013.01); A61F 9/00772 (2013.01); A61F 9/00781 (2013.01); A61K 9/00 (2013.01); A61K 9/0017 (2013.01); A61K 9/06 (2013.01); A61K 31/215 (2013.01); A61K 31/216 (2013.01); A61K 31/55 (2013.01); A61K 31/557 (2013.01); A61K 31/5575 (2013.01); A61K 31/573 (2013.01); A61K 47/34 (2013.01); A61L 31/16 (2013.01); A61F 2220/0008 (2013.01); A61F 2250/0067 (2013.01); A61F 2250/0087 (2013.01)] | 14 Claims |

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1. A method for delivery of a therapeutic agent to an eye of a patient using a punctal plug, comprising:
positioning the punctal plug into a lacrimal punctum of an eye wherein the punctal plug comprises a plug body and a drug insert, wherein the drug insert comprises a drug core comprising a therapeutic agent and a polymer matrix, and wherein the plug body comprises silicone; 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 the therapeutic agent to the eye; and,
delivering a dose of the therapeutic agent to the eye for a sustained treatment period, wherein the punctal plug remains in position for the sustained treatment period for at least of one week to 3 months.
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