Sustained release delivery of active agents to treat glaucoma and ocular hypertension
Inventors
Cadden, Suzanne • Hao, Yong • Utkhede, Deepank • Rubinchik, Valery • Kjellbotn, Charles Richard
Assignees
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Publication Number
US-9610271-B2
Publication Date
2017-04-04
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 document describes implanting lacrimal (punctal) implants to reduce intraocular pressure (IOP) in glaucoma and ocular hypertension. Sustained-release intraocular pressure-reducing agents are delivered via lacrimal implants that include upper and lower punctal placements, each configured for insertion into a lacrimal canaliculus.
A key concept is that a dual-implant arrangement with one implant in an upper punctum and one implant in a lower punctum yields statistically significant IOP reduction after about two weeks, including target IOP reductions described in the document. In contrast, single-implant delivery is characterized as dose-insensitive within the described single-plug dose loading range, with minimal IOP reduction reported across that range.
The implants are defined as multi-member lacrimal insertion devices having angled intersection geometry and a bore that is accessible to an insertion tool to facilitate insertion. The implants include a first member extending into the canaliculus, a second member configured to reside in a vertical portion and extend to an opening of, or out of, an associated lacrimal punctum, and a third member connecting the first and second members at an angled intersection.
Claims Coverage
The document provides two independent claims directed to a lacrimal canaliculus insertion implant. Across these claims, the main inventive features include a multi-member implant with angled intersections and defined angular relationships, a tool-accessible bore for facilitating insertion, and an optional cavity configured to house a therapeutic agent core extending along the second member axis.
Three-member lacrimal insertion implant with angled intersection and tool-accessible bore
An implant for insertion into a lacrimal canaliculus including a first member configured to extend into the canaliculus, a second member configured to reside in a vertical portion and extend to an opening of, or out of, an associated lacrimal punctum, and a third member connecting ends of the first and second members at an angled intersection, wherein the third member comprises a bore defining a third axis and a second angle and having an upper surface, the bore configured to be accessible to an insertion tool and extending from the upper surface into the third member, and wherein the first angle and second angle are constrained to specified ranges.
Angled-intersection implant with therapeutic-agent cavity extending into the second member
An implant for insertion into a lacrimal canaliculus including a first member configured to extend into the canaliculus and a second member configured to reside in a vertical portion and extend to an opening of, or out of, an associated lacrimal punctum, further including a cavity configured to house a therapeutic agent core with the cavity extending into the second member along the second axis, and further including a third member connecting the first end and second end at a first angle to form an angled intersection with a bore in the third member accessible to an insertion tool, wherein the first angle and second angle are constrained to specified ranges.
Overall, claim coverage focuses on a geometric implant structure for lacrimal canaliculus insertion, with first and second members positioned along respective axes and connected by a third member forming an angled intersection, a bore accessible to an insertion tool, and in one independent claim a therapeutic-agent cavity extending into the second member to house a therapeutic agent core.
Stated Advantages
Statistically significant IOP reduction after about two weeks with dual-implant upper and lower placement.
Achievement of target IOP reductions with dual-implant placement.
Single-implant delivery is characterized as dose-insensitive within the described single-plug dose loading range, with minimal IOP reduction across the range.
Documented Applications
Reducing intraocular pressure (IOP) in glaucoma and ocular hypertension using lacrimal (punctal) implants delivering sustained-release intraocular pressure-reducing agents.
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