High elasticity hyaluronan compositions and methods of use thereof

• US 10,383,889 B2
• Filed: 09/21/2016
• Issued: 08/20/2019
• Est. Priority Date: 09/24/2015
• Status: Active Grant

• Current Assignee: Matrix Biology Institute
• Original Assignee: Matrix Biology Institute
• Inventors: Belmonte, Carlos, Denlinger, Janet L.
• Primary Examiner(s): Miller, Dale R
• Application Number:
  US15/271,434
• Publication Number:
  US 20170087177A1
• Time in Patent Office: 1,063 Days
• Field of Search: None
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

The present invention provides methods for alleviating pain and discomfort associated with a dry eye condition; methods for alleviating pain and discomfort while minimizing at least one skin imperfection; and methods for alleviating pain and discomfort while facilitating wound healing. The methods involve administering to a subject in need thereof a composition comprising hyaluronan with high elasticity.

Claims

1. A method for alleviating pain and discomfort associated with a dry eye condition in a subject in need thereof, the method comprising administering to an eye of said subject a composition comprising hyaluronan, wherein:

the hyaluronan is present in said composition at a concentration of greater than about 30 mg/mL;

the hyaluronan has an average molecular weight of between about 1 and about 2 million;

the hyaluronan is not cross-linked and/or is free of chemical modifications;

wherein the composition is free of a local anesthetic, thereby alleviating said pain and discomfort in said subject; and

wherein the dry eye condition is associated with one or more symptoms selected from the group consisting of ocular dryness;

decreased tear production, volume, and flow;

abnormal tear composition;

increased tear osmolarity;

keratitis;

conjunctival and corneal staining;

redness;

blurry vision;

decreased tear film break-up time;

increased conjunctival redness;

excess debris in tear film, ocular grittiness;

ocular burning;

foreign body sensation in the eye;

excess tearing;

photophobia;

ocular stinging;

refractive impairment;

ocular sensitivity;

ocular irritation and discomfort resulting from prolonged contact lens wear.

2. The method of claim 1, wherein hyaluronan is present in the composition at a concentration of about 40 mg/mL to about 60 mg/mL.

4. The method of claim 1 or 3, wherein the composition does not comprise a polyglycol.

5. The method of claim 1 or 3, wherein the composition further comprises a buffer.

6. The method of claim 1 or 3, wherein the buffer is phosphate buffered saline (PBS).

7. The method of claim 1 or 3, wherein the composition has an elasticity of at least about 200 Pascal when measured at a frequency of 0.5 Hz.

8. The method of claim 1 or 3, wherein the composition has an elasticity of at least about 1,000 Pascal when measured at a frequency of 0.5 Hz.

9. The method of claim 1 or 3, wherein the composition has an elasticity of at least about 2,000 Pascal when measured at a frequency of 0.5 Hz.

10. The method of claim 1 or 3, wherein the composition has an elasticity of at least about 4,000 Pascal when measured at a frequency of 0.5 Hz.

11. The method of claim 1 or 3, wherein the composition is sterile.

12. The method of claim 1 or 3, wherein the composition is in the form of a gel, an ointment, a liniment, a lotion or a cream.

13. The method of claim 1 or 3, wherein the composition is administered to the ocular surface.

14. The method of claim 13, wherein the composition is administered under the eye lid of said subject.

15. The method of claim 13, wherein said composition is administered at the cornea-eyelid interface.

16. The method of claim 13, wherein the composition is administered to the subject immediately prior to rest or sleep.

17. The method of claim 1 or 3, wherein the composition is administered without an injection into the eye of said subject.

18. The method of claim 17, wherein the composition is administered using a container selected from the group consisting of a single dose container, a soft plastic bottle, a tube, an airless tube, an eye cup, a dropper and a cartridge.

19. The method of claim 13, wherein said composition is administered daily for 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 4 weeks or 10 weeks.

20. The method of claim 1 or 3, wherein amelioration of the pain and discomfort is achieved in said subject for 8 hours, 12 hours, 24 hours, 1 day, 3 days, 5 days, 7 days, 14 days or 28 days.

21. The method of claim 1 or 3, wherein said subject is a mammal.

22. The method of claim 21, wherein said subject is a human.

3. A method for alleviating pain and discomfort associated with a dry eye condition in a subject in need thereof, the method comprising administering to an eye of said subject a composition comprising hyaluronan, wherein:

the hyaluronan is present in said composition at a concentration of at least about 40 mg/mL;

the hyaluronan has an average molecular weight of between about 1 and about 2 million;

the hyaluronan is not cross-linked and/or is free of chemical modifications;

wherein the composition is free of a local anesthetic, thereby alleviating said pain and discomfort in said subject; and

wherein the dry eye condition is associated with one or more symptoms selected from the group consisting of ocular dryness;

decreased tear production, volume, and flow;

abnormal tear composition;

increased tear osmolarity;

keratitis;

conjunctival and corneal staining;

redness;

blurry vision;

decreased tear film break-up time;

increased conjunctival redness;

excess debris in tear film, ocular grittiness;

ocular burning;

foreign body sensation in the eye;

excess tearing;

photophobia;

ocular stinging;

refractive impairment;

ocular sensitivity;

ocular irritation and discomfort resulting from prolonged contact lens wear.