IP Library Granted Patent US 10,709,680
Granted Patent B2
US 10,709,680 · App. 15/910,661 · Granted Jul 14, 2020

Methods for treating dry eye

Inventors: S. Gregory Smith (Yorklyn, DE); Michael B. Gross (Plymouth Meeting, PA); Olav E. Sandnes (Mt. Bethel, PA)
A61K31/202A61K31/215A61K31/232A61K31/593A61P27/04
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Quick Facts
Patent No.
US 10,709,680
App. No.
15/910,661
Granted
Jul 14, 2020
Kind
B2
Abstract

This invention relates to methods for improving the quality of the meibum composition of the meibomian glands to enhance or improve the lipid layer of the tear and increase tear breakup time by way of elevating the omega-3 index in patients suffering from symptoms of dry eye, posterior blepharitis, and/or meibomian gland dysfunction. The methods comprise administering a supplementation of omega-3 fatty acids to a patient having an inflamed meibomian gland so as to facilitate an increase in the amount of omega-3's acting as an anti-inflammatory and, respectively, decrease the amount of omega-6's (arachidonic acid) acting as an inflammatory in the composition of the meibum, thereby normalizing the lipid layer of the tear and effectively reducing the associated symptoms. In certain embodiments, the supplementation of omega-3's comprises the esterified or re-esterified triglyceride form.

Claims (30)

1. A method for treating dry eye and improving the quality of the meibum composition of inflamed or dysfunctional meibomian glands of a mammal, comprising the steps of:

administering a composition consisting essentially of an effective amount of omega-3 fatty acids on a daily dosage basis to said mammal having inflamed or dysfunctional meibomian glands, wherein said amount of omega-3 fatty acids comprises eicosapentaenoic acid (EPA) in an amount greater than 600 mg and in the re-esterified triglyceride form; and wherein said composition is devoid of omega-6 fatty acids;

increasing levels of anti-inflammatory omega-3's in the meibum composition of said treated meibomian glands of said mammal; and

decreasing levels of inflammatory omega-6's in the meibum composition of said treated meibomian glands.

2. The method as defined in claim 1 , further comprising the steps of taking a baseline measurement of tear break up time of said mammal prior to administering said composition and taking a second measurement of tear break up time of said mammal after administration of said composition to evaluate an improvement of tear break up time of said mammal as compared to said corresponding baseline measurement.

3. The method as defined in claim 1 , further comprising the steps of taking a baseline measurement of tear osmolarity of said mammal prior to administering said composition and taking a second measurement of tear osmolarity of said mammal after administration of said composition to evaluate a reduction of tear osmolarity of said mammal as compared to said corresponding baseline measurement.

4. The method as defined in claim 1 , further comprising the steps of taking a baseline measurement of the quality of tears of said mammal prior to administering said composition and taking a second measurement of the quality of tears of said mammal after administration of said composition to evaluate an improvement in the quality of tears of said mammal as compared to said corresponding baseline measurement.

5. The method as defined in claim 1 , wherein said amount of EPA comprises between 600 mg and 2,500 mg.

6. The method as defined in claim 1 , wherein said amount of omega-3 fatty acids comprises an effective amount of docosahexaenoic acid (DHA).

7. The method as defined in claim 6 , wherein said effective amount of DHA comprises an amount greater than 500 mg.

8. The method as defined in claim 6 , wherein said effective amount of DHA comprises between 500 mg and 900 mg.

9. The method as defined in claim 6 , wherein said amount of EPA and said amount of DHA comprises a 3:1 weight ratio.

10. A method for treating dry eye and improving the quality of the meibum composition of inflamed or dysfunctional meibomian glands of a mammal, comprising the steps of:

administering a composition consisting essentially of an effective amount of omega-3 fatty acids on a daily dosage basis to said mammal having inflamed or dysfunctional meibomian glands, wherein said amount of omega-3 fatty acids comprises eicosapentaenoic acid (EPA) in an amount greater than 600 mg and in the re-esterified triglyceride form and docosahexaenoic acid (DHA) in an amount greater than 500 mg and in the re-esterified triglyceride form; and wherein said composition is devoid of omega-6 fatty acids;

increasing levels of anti-inflammatory omega-3's in the meibum composition of said treated meibomian glands of said mammal; and

decreasing levels of inflammatory omega-6's in the meibum composition of said treated meibomian glands.

11. The method as defined in claim 10 , further comprising the steps of taking a baseline measurement of tear break up time of said mammal prior to administering said composition and taking a second measurement of tear break up time of said mammal after administration of said composition to evaluate an improvement of tear break up time of said mammal as compared to said corresponding baseline measurement.

12. The method as defined in claim 10 , further comprising the steps of taking a baseline measurement of tear osmolarity of said mammal prior to administering said composition and taking a second measurement of tear osmolarity of said mammal after administration of said composition to evaluate a reduction of tear osmolarity of said mammal as compared to said corresponding baseline measurement.

13. The method as defined in claim 10 , further comprising the steps of taking a baseline measurement of the quality of tears of said mammal prior to administering said composition and taking a second measurement of the quality of tears of said mammal after administration of said composition to evaluate an improvement in the quality of tears of said mammal as compared to said corresponding baseline measurement.

14. The method as defined in claim 10 , wherein said amount of EPA comprises between 600 mg and 2,500 mg.

15. The method as defined in claim 10 , wherein said amount of DHA comprises between 500 mg and 900 mg.

16. The method as defined in claim 10 , wherein said amount of EPA and said amount of DHA comprises a 3:1 weight ratio.

17. A method for treating dry eye and improving the quality of the meibum composition of inflamed or dysfunctional meibomian glands of a mammal, comprising the steps of:

taking a baseline measurement of tear quality of said mammal;

administering a composition consisting essentially of an effective amount of omega-3 fatty acids on a daily dosage basis to said mammal having inflamed or dysfunctional meibomian glands, wherein said amount of omega-3 fatty acids comprises eicosapentaenoic acid (EPA) in an amount between 600 mg and 2,500 mg and in the re-esterified triglyceride form and docosahexaenoic acid (DHA) in an amount between 500 mg and 900 mg and in the re-esterified triglyceride form; and wherein said composition is devoid of omega-6 fatty acids;

increasing levels of anti-inflammatory omega-3's in the meibum composition of said treated meibomian glands of said mammal; and

decreasing levels of inflammatory omega-6's in the meibum composition of said treated meibomian glands.

18. The method as defined in claim 17 , further comprising the step of taking a second measurement of tear quality of said mammal after administration of said composition to evaluate an improvement of tear quality of said mammal as compared to said corresponding baseline measurement.

19. The method as defined in claim 17 , further comprising the steps of taking a baseline measurement of tear break up time of said mammal prior to administering said composition and taking a second measurement of tear break up time of said mammal after administration of said composition to evaluate an improvement of tear break up time of said mammal as compared to said corresponding baseline measurement.

20. The method as defined in claim 17 , further comprising the steps of taking a baseline measurement of tear osmolarity of said mammal prior to administering said composition and taking a second measurement of tear osmolarity of said mammal after administration of said composition to evaluate a reduction of tear osmolarity of said mammal as compared to said corresponding baseline measurement.

Assignments (2)
SECURITY INTEREST Recorded Aug 31, 2021
From: PRN PHYSICIAN RECOMMENDED NUTRICEUTICALS, LLC
To: CAPITAL ONE, NATIONAL ASSOCIATION, AS AGENT
Reel/Frame 057339/0669 →
NUNC PRO TUNC ASSIGNMENT Recorded Jul 8, 2020
From: SMITH, S GREGORY; GROSS, MICHAEL B; SANDNES, OLAV E
To: PRN PHYSICIAN RECOMMENDED NUTRICEUTICALS LLC
Reel/Frame 053155/0149 →
Continuity (5)
Continuation In Part 15197212 · Jun 29, 2016
Continuation In Part 13815599 · Mar 12, 2013
Continuation In Part 13507673 · Jul 18, 2012
Provisional Application 61572574 · Jul 18, 2011
Related Publication 20180214407A1 · Aug 2, 2018