Drug delivery system and methods of treating open angle glaucoma and ocular hypertension

• US 9,974,685 B2
• Filed: 02/27/2013
• Issued: 05/22/2018
• 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
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): KLEIN, BENJAMIN JACOB
• Application Number:
  US13/779,628
• Publication Number:
  US 20140025022A1
• Time in Patent Office: 1,910 Days
• Field of Search: 604 8- 10
• 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 31/5575 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

Abstract

A method of decreasing intraocular pressure (IOP) in an eye of a patient in need thereof includes implanting a first lacrimal implant through an upper punctum and into an upper lacrimal canaliculus of the eye of the patient. The method may further comprise implanting a second lacrimal implant through a lower punctum and into a lower 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. A method of treating a patient with Open Angle Glaucoma (OAG) or Ocular Hypertension (OH) in an eye, comprising:

providing a unit dosage of a prostaglandin analog to an eye over a treatment period, wherein the prostaglandin analog is administered from a lacrimal implant comprising a sustained release formulation and the prostaglandin analog is released in a therapeutically effective dose from the lacrimal implant over the treatment period,

wherein the lacrimal implant is inserted into a lower punctum and a blank lacrimal implant that does not comprise a therapeutic agent is inserted in an upper punctum;

or the lacrimal implant is inserted into an upper punctum and a blank lacrimal implant that does not comprise a therapeutic agent is inserted in a lower punctum; and

,

wherein the lacrimal implant comprises a first member defining a first axis and having a first end along the first axis;

a second member defining a second axis and having a second end along the second axis; and

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 and wherein the third member of the lacrimal implant having an upper surface, and further comprising a bore defining a third axis and a second angle, wherein the first angle is defined by the first axis with respect to the second axis, the second angle is defined by the first axis with respect to the third axis, and the bore is configured to be accessible to an insertion tool for facilitating insertion of the implant and wherein the bore extends from the upper surface into the third member.

2. The method of claim 1, wherein the lacrimal implant is a punctual plug.

3. The method of claim 1, wherein the second member of the lacrimal implant further comprises a cavity for insertion of a drug core comprising the prostaglandin analog.

4. The method of claim 1, wherein the lacrimal implant further comprises the prostaglandin analog dispersed throughout the implant.

5. The method of claim 1, wherein the lacrimal implant is configured with a retention rate of about 90% or greater at week 12 in a lower punctum.

6. The method of claim 1, wherein the lacrimal implant is configured with a retention rate of about 85% or greater at week 8 in the upper punctum.

7. The method of claim 1, wherein the lacrimal implant is made of a material that comprises a plastic, a rubber, a polymer, a composite or a material that comprises a liquid silicone rubber, or a mixture including a liquid silicone rubber.

8. The method of claim 7, wherein the lacrimal implant further comprises a green colorant.

9. The method of claim 1, wherein the lacrimal implant comprises a first member, a second member and a heel that is at least partially fabricated with silicone.

10. A method of treating a patient with Open Angle Glaucoma (OAG) or Ocular Hypertension (OH) in an eye by reducing intraocular pressure (TOP) in the eye, comprising:

providing a unit dosage of a prostaglandin analog to an eye over a treatment period of at least 4 weeks, wherein the prostaglandin analog is administered from a lacrimal implant comprising a sustained release formulation and the prostaglandin analog is released in a therapeutically effective dose from the lacrimal implant over the treatment period of at least 4 weeks,

wherein the lacrimal implant is inserted into a lower punctum and a blank lacrimal implant that does not comprise a therapeutic agent is inserted in an upper punctum;

or the lacrimal implant is inserted into an upper punctum and a blank lacrimal implant that does not comprise a therapeutic agent is inserted in a lower punctum; and

,

wherein the lacrimal implant comprises a first member defining a first axis and having a first end along the first axis;

a second member defining a second axis and having a second end along the second axis; and

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 and wherein the third member of the lacrimal implant having an upper surface, and further comprising a bore defining a third axis and a second angle, wherein the first angle is defined by the first axis with respect to the second axis, the second angle is defined by the first axis with respect to the third axis, and the bore is configured to be accessible to an insertion tool for facilitating insertion of the implant and wherein the bore extends from the upper surface into the third member.

11. The method of claim 10, wherein the baseline intraocular pressure is between about 22 mm Hg and about 33 mm Hg.

12. The method of claim 10, wherein the lacrimal implant is inserted into an upper punctum of the eye.

13. The method of claim 12, wherein a second lacrimal implant that does not comprise a therapeutic agent is inserted into a lower punctum of the eye.

14. A method of treating a patient with Open Angle Glaucoma (OAG) or Ocular Hypertension (OH) in an eye by reducing intraocular pressure (TOP) in the eye, comprising:

a) measuring the TOP of the patient to obtain a baseline TOP before treatment;

b) providing a unit dosage of a prostaglandin analog as a sustained release formulation;

c) delivering the sustained release formulation to the eye using a lacrimal implant comprising the sustained release formulation; and

d) releasing the prostaglandin analog to the eye on a sustained basis over at least 8 weeks, wherein the lacrimal implant is inserted into a lower punctum and a blank lacrimal implant that does not comprise a therapeutic agent is inserted in an upper punctum;

or the lacrimal implant is inserted into an upper punctum and a blank lacrimal implant that does not comprise a therapeutic agent is inserted in a lower punctum,

wherein the lacrimal implant comprises a first member defining a first axis and having a first end along the first axis;

a second member defining a second axis and having a second end along the second axis; and

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 and wherein the third member of the lacrimal implant having an upper surface, and further comprising a bore defining a third axis and a second angle, wherein the first angle is defined by the first axis with respect to the second axis, the second angle is defined by the first axis with respect to the third axis, and the bore is configured to be accessible to an insertion tool for facilitating insertion of the implant and wherein the bore extends from the upper surface into the third member.

15. The method of claim 14, wherein the baseline TOP is between about 22 mm Hg and about 33 mm Hg.

16. The method of claim 14, wherein in the second member of the lacrimal implant further comprises a cavity for insertion of a drug core comprising the prostaglandin analog.

17. The method of claim 14, wherein the lacrimal implant further comprises the prostaglandin analog dispersed throughout the implant.

18. The method of claim 14, wherein the lacrimal implant is made of a material that comprises a plastic, a rubber, a polymer, a composite or a material that comprises a liquid silicone rubber, or a mixture including a liquid silicone rubber.

19. The method of claim 18, wherein the lacrimal implant further comprises a green colorant.

20. The method of claim 14, wherein the lacrimal implant comprises a first member, a second member and a heel that is at least partially fabricated with silicone.