Sustained release delivery of active agents to treat glaucoma and ocular hypertension
Inventors
Cadden, Suzanne • Hao, Yong • Utkhede, Deepank • Rubinchik, Valery • Kjelbotn, Charles Richard
Assignees
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Publication Number
US-10632012-B2
Publication Date
2020-04-28
Expiration Date
Abstract
A method of decreasing intraocular pressure (IOP) in an eye of a patient in need thereof includes implanting a first lacrimal implant through a firsts punctum and into a first lacrimal canaliculus of the eye of the patient. The method may further comprise implanting a second lacrimal implant through a second punctum and into a second lacrimal canaliculus of the eye of the patient, and releasing, on a sustained basis a therapeutically effective amount of an intraocular pressure-reducing therapeutic agent.
Core Innovation
The invention provides sustained-release treatment of glaucoma or ocular hypertension by implanting one or two lacrimal implants into upper and/or lower puncta and canaliculi to deliver a therapeutically effective amount of an IOP-reducing agent over time. The document reports that implanting two latanoprost-eluting implants yields a statistically significant reduction in intraocular pressure after about two weeks.
The implant geometry is defined for insertion into a lacrimal canaliculus, including first and second members defining respective first and second axes, and a third member that connects the first end and the second end at an angled intersection. The third member includes a bore defining a third axis and a second angle, and the bore is configured to be accessible to an insertion tool for facilitating insertion.
In an embodiment, the implant further includes a cavity configured to house a therapeutic agent core, with the cavity extending into the second member along the second axis. The therapeutic agent core includes a therapeutic agent and optionally a matrix, and release is described in connection with a sheath body and sustained release of an antiglaucoma agent, including prostaglandin or prostaglandin analogue examples such as latanoprost.
Claims Coverage
The partial content includes two independent claims: one directed to an implant insertion geometry in a lacrimal canaliculus, and one directed to the same insertion geometry combined with a cavity for housing a therapeutic agent core. Each independent claim includes angle ranges and a bore accessible to an insertion tool, with the second independent claim additionally reciting a cavity extending into the second member.
Angled intersection implant geometry with insertion-accessible bore
A method of using an implant for insertion into a lacrimal canaliculus comprising placing the implant into the lacrimal canaliculus, wherein the implant includes first and second members defining first and second axes configured to extend into the canaliculus and to reside in a vertical portion and extend to an opening of, or out of the opening of, an associate lacrimal punctum; a third member connecting ends at an angled intersection; and the third member comprising a bore defining a third axis and a second angle and having an upper surface, wherein the bore is configured to be accessible to an insertion tool and extends from the upper surface into the third member; with the first angle defined by the first axis with respect to the second axis from 30 degrees to 150 degrees and the second angle defined by the first axis with respect to the third axis from 15 degrees to 90 degrees.
Cavity for therapeutic agent core combined with angled intersection geometry
A method of using an implant for insertion into a lacrimal canaliculus comprising placing the implant into the lacrimal canaliculus, wherein the implant includes first and second members defining first and second axes configured to extend into the canaliculus and to reside in a vertical portion and extend to an opening of, or out of the opening of, an associate lacrimal punctum; a cavity configured to house a therapeutic agent core and extending into the second member along the second axis; and a third member connecting the first end and second end at an angled intersection, wherein the third member comprises a bore defining a third axis and a second angle and having an upper surface; wherein the bore is accessible to an insertion tool and extends from the upper surface into the third member; with the first angle from 30 degrees to 150 degrees and the second angle from 15 degrees to 90 degrees.
Across both independent claims, the core claim coverage centers on a lacrimal canaliculus implant having first and second members defining axes that meet at an angled intersection via a third member, where the third member includes a bore accessible to an insertion tool, with specified ranges for the first angle and second angle. The second independent claim further adds a cavity configured to house a therapeutic agent core that extends into the second member along the second axis.
Stated Advantages
Statistically significant reduction in intraocular pressure after about two weeks with two latanoprost-eluting implants (upper plus lower).
Documented Applications
Sustained-release treatment of glaucoma or ocular hypertension by delivering an IOP-reducing agent using one or two lacrimal implants placed in upper and/or lower puncta and canaliculi.
Administration of a therapeutic agent to an eye using an implant whose therapeutic agent core comprises the therapeutic agent and a matrix.
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