Sustained release delivery of active agents to treat glaucoma and ocular hypertension

• US 9,610,271 B2
• Filed: 12/20/2013
• Issued: 04/04/2017
• Est. Priority Date: 08/29/2011
• Status: Active Grant

• Current Assignee: Mati Therapeutics, Inc
• Original Assignee: Mati Therapeutics, Inc
• Inventors: Cadden, Suzanne, Hao, Yong, Utkhede, Deepank, Rubinchik, Valery, Kjellbotn, Charles Richard
• Primary Examiner(s): Wiest, Philip R
• Assistant Examiner(s): SASS, SARA A
• Application Number:
  US14/136,024
• Publication Number:
  US 20140350103A1
• Time in Patent Office: 1,201 Days
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/5575 having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/06 Antiglaucoma agents or miotics

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.

Claims

1. An implant for insertion into a lacrimal canaliculus, the implant comprising:

a first member defining a first axis and having a first end along the first axis, wherein the first member is configured to extend into the canaliculus;

a second member defining a second axis and having a second end along the second axis, wherein the second member is configured to reside in a vertical portion of the canaliculus and to extend to an opening of, or out of the opening of, an associate lacrimal punctum;

a third member connecting the first end of the first member and the second end of the second member at a first angle to form an angled intersection;

the third member comprises 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 for facilitating insertion of the implant and extends from the upper surface into the third member; and

further wherein the first angle is defined by the first axis with respect to the second axis and the second angle is defined by the first axis with respect to the third axis;

wherein the first angle is from 30 degrees to 150 degrees;

wherein the second angle is from 15 degrees to 90 degrees.

2. The implant of claim 1, wherein the implant is made of a material selected from the group consisting of:

plastic, rubber, polymer and a composite.

3. The implant of claim 1, wherein the first angle is from about 75 degrees to about 105 degrees.

4. The implant of claim 1, wherein the first member comprises an intermediate segment, a tip segment and a forward segment in between the intermediate segment and the tip segment.

5. The implant of claim 4, wherein the forward segment is tapered and has a conical shape, such that the forward segment connects the intermediate segment at one end and the tip segment at the other end.

6. The implant of claim 4, wherein the intermediate segment has a cylindrical shape.

7. The implant of claim 4, wherein the tip segment is substantially a semi-sphere or a portion of a semi-sphere.

8. The implant of claim 7, wherein the length of the intermediate segment is from about 0.5 mm to about 3.5 mm;

a radius of the tip segment is from about 0.05 mm to about 0.3 mm; and

the length of forward segment is from about 1.0 mm to 5.0 mm.

9. The implant of any one of claim 1, wherein the bore extends from an upper surface into the third member and the upper surface extends beyond the intersection with the second member.

10. The implant of claim 1, wherein the third member comprises a heel connecting segment configured to couple the third member to the first member, wherein a width of the heel connecting segment in the direction of the second axis varies along the direction of the first axis.

11. The implant of claim 1, wherein the second angle is about 45 degrees.

12. The implant of claim 1, wherein the bore has a depth along the direction of the third axis that is from about 0.3 mm to about 0.7 mm.

13. The implant of claim 1, further comprising a cavity that is configured to house a therapeutic agent core.

14. The implant of claim 13, wherein the implant is formatted as a unit dosage of an antiglaucoma agent.

15. The implant of claim 14, wherein the antiglaucoma agent is a prostaglandin or prostaglandin analogue.

16. The implant of claim 13, further comprising the therapeutic agent core comprising a therapeutic agent and a matrix.

17. The implant of claim 16, wherein the therapeutic agent core comprises a therapeutic agent selected from an anti-inflammatory agents, anti-fungal agents, anti-viral agents, anti-glaucoma drugs, anti-microbial agents, and steroidal compounds.

18. An implant for insertion into a lacrimal canaliculus, the implant comprising:

a first member defining a first axis and having a first end along the first axis, wherein the first member is configured to extend into the canaliculus;

a second member defining a second axis and having a second end along the second axis, wherein the second member is configured to reside in a vertical portion of the canaliculus and to extend to an opening of, or out of the opening of, an associate lacrimal punctum;

a cavity that is configured to house a therapeutic agent core, wherein the cavity extends into the second member along the second axis;

a third member connecting the first end of the first member and the second end of the second member at a first angle to form an angled intersection;

the third member comprises 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 for facilitating insertion of the implant and extends from the upper surface into the third member; and

further wherein the first angle is defined by the first axis with respect to the second axis and the second angle is defined by the first axis with respect to the third axis;

wherein the first angle is from 30 degrees to 150 degrees;

wherein the second angle is from 15 degrees to 90 degrees.

19. The implant of claim 18, further comprising the therapeutic agent core comprising a therapeutic agent and a matrix.

20. The implant of claim 18, wherein the cavity comprises a depth from about 0.2 mm to about 1.4 mm.