Sustained release delivery of active agents to treat glaucoma and ocular hypertension
Inventors
Assignees
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Publication Number
US-9949942-B2
Publication Date
2018-04-24
Expiration Date
Abstract
The methods described herein provide treatment of glaucoma, ocular hypertension, and elevated intraocular pressure with latanoprost or other therapeutic agent(s). Implant devices for insertion into a punctum of a patient provide sustained release of latanoprost or other therapeutic agent(s) that is maintained for 7, 14, 21, 30, 45, 60, or 90 days or more, thus avoiding patient noncompliance and reducing or lowering adverse events associated with eye drop administration of latanoprost or other therapeutic agent(s) and other therapeutic agent(s).
Core Innovation
The invention relates to a sustained release topical formulation for reducing intraocular pressure in an eye of a patient having open angle glaucoma or ocular hypertension with a baseline intraocular pressure of 21-30 mmHg. The method administers an intraocular pressure-reducing therapeutic agent that is capable of continuously releasing the therapeutic agent from a punctal implant for at least 7 days. The intraocular pressure is reduced at least 10% from baseline while providing a sustained release approach from the eye.
The sustained release topical formulation is delivered via a punctal implant that includes a first, second and intermediate portion. The implant extends from a proximal end of the first portion defining a proximal axis to a distal end of the second portion defining a distal axis, and when implanted is configured with an at least 45 degree angled intersection between the proximal axis and the distal axis to bias at least a portion of the implant against at least a portion of a lacrimal canaliculus located at or more distal to a canaliculus curvature and to bias the intermediate portion against a portion of a lacrimal canaliculus ampulla.
The punctal implant delivers the therapeutic agent as a sustained release topical formulation drug core comprising a matrix and the therapeutic agent. The disclosed drug core structures include a matrix with latanoprost and optionally other anti-glaucoma/prostaglandin agents, and embodiments describe polymer-based formulations and non-bioabsorbable or non-erodible polymer materials. Impermeable or coated structures are described, including impermeable coatings such as parylene, to support delivery of the drug from the punctal implant into tear fluid over an extended duration.
Claims Coverage
The partial content identifies two independent method claims, each focused on reducing intraocular pressure in patients with open angle glaucoma or ocular hypertension using a punctal implant that provides continuous sustained release of an intraocular pressure-reducing therapeutic agent for at least 7 days, with at least a 10% reduction from baseline. Both independent claims further include the same three-portion punctal implant geometry that uses an angled intersection to bias against lacrimal canaliculus structures and the lacrimal canaliculus ampulla.
Continuous sustained release intraocular pressure reduction from a punctal implant
Administering to the eye of a patient having open angle glaucoma or ocular hypertension and a baseline intraocular pressure of 21-30 mmHg an intraocular pressure-reducing therapeutic agent sustained release topical formulation capable of continuously releasing the intraocular pressure-reducing therapeutic agent over at least 7 days to the eye from a punctal implant wherein the intraocular pressure is reduced at least 10% from baseline.
Three-portion punctal implant with at least 45 degree angled intersection for canaliculus biasing
A punctal implant comprises a first, second and intermediate portion extending from a proximal end of the first portion defining a proximal axis to a distal end of the second portion defining a distal axis, and when implanted is configured with an at least 45 degree angled intersection between the proximal axis and the distal axis for biasing at least a portion of the implant against at least a portion of a lacrimal canaliculus located at or more distal to a canaliculus curvature and wherein the intermediate portion projects proximally from the intersection between the first and second implant body portions and is configured to bias against a portion of a lacrimal canaliculus ampulla.
Sustained release topical formulation drug core comprising a matrix and the therapeutic agent
Inserting a punctal implant into at least one punctum of the eye wherein the implant comprises an intraocular pressure-reducing therapeutic agent sustained release topical formulation drug core comprising a matrix and the therapeutic agent, wherein the sustained release topical formulation is capable of continuously releasing the intraocular pressure-reducing therapeutic agent over at least 7 days to the eye wherein the intraocular pressure is reduced at least about 10% from baseline.
Across the identified independent claims, the inventive focus is on using a punctal implant to continuously release an intraocular pressure-reducing therapeutic agent for at least 7 days with at least a 10% reduction from baseline, and on a punctal implant geometry having a first, second and intermediate portion with an at least 45 degree angled intersection configured to bias against lacrimal canaliculus structures and the lacrimal canaliculus ampulla, with the therapeutic agent provided as a sustained release topical formulation drug core comprising a matrix and the therapeutic agent.
Stated Advantages
A method that reduces intraocular pressure at least 10% from baseline while providing continuous sustained release over at least 7 days.
Documented Applications
Reducing intraocular pressure in a patient having open angle glaucoma or ocular hypertension with a baseline intraocular pressure of 21-30 mmHg by administering a sustained release topical formulation via a punctal implant.
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