IP Library Granted Patent US 9,403,765
Granted Patent B2
US 9,403,765 · App. 13/619,945 · Granted Aug 2, 2016

Retinal derivatives and methods for the use thereof for the treatment of visual disorders

Inventors: Krzysztof Palczewski (Bay Village, OH); Matthew Batten (Seattle, WA)
Assignee: University of Washington
C07C403/14A61K31/215A61K31/22C07C403/10C07C403/12C07C403/20C07B2200/09C07C2101/10C07C2101/16
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Quick Facts
Patent No.
US 9,403,765
App. No.
13/619,945
Granted
Aug 2, 2016
Kind
B2
Abstract

Compositions of and methods for using synthetic retinal derivatives as retinoid replacements and opsin agonists are provided.

Claims (30)

1. A method of ameliorating or restoring photoreceptor function in a human eye, comprising:

administering an effective amount of a synthetic retinyl ester that is a 9-cis-retinyl ester or an 11-cis-retinyl ester to a human subject with a deficiency in endogenous 11-cis-retinal in the eye,

wherein the 9-cis-retinyl ester has a structure as represented by Formula I or the 11-cis-retinyl ester has a structure as represented by Formula II, wherein A in each formula is CH 2 OR and —R, along with the adjacent oxygen, forms a retinyl ester, and the ester substituent comprises a carboxylate radical of a C 1 to C 10 monocarboxylic acid or a C 2 to C 22 polycarboxylic acid:

2. The method of claim 1 , wherein the ester substituent comprises a carboxylate radical of a C 2 to C 22 polycarboxylic acid.

3. The method of claim 1 , wherein the ester substituent comprises a carboxylate radical of a C 1 to C 10 monocarboxylic acid.

4. The method of claim 1 , wherein the endogenous 11-cis retinal deficiency is associated with Retinitis Pigmentosa (RP), Leber Congenital Amaurosis (LCA), Retinitis Punctata Albesciens, Congenital Stationary Night Blindness, Fundus Albipunctatus, Age-Related Macular Degeneration, loss of night vision or contrast sensitivity.

5. The method of claim 4 , wherein endogenous 11-cis retinal deficiency is associated with Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP).

6. The method of claim 1 , wherein the human subject has a mutation selected from an RPE65 mutation and an LRAT mutation.

7. The method of claim 1 , wherein the synthetic retinyl ester is locally administered by eye drops, intraocular injection or periocular injection to the human subject.

8. The method of claim 1 , wherein the synthetic retinyl ester is orally administered to the human subject.

9. The method of claim 1 , wherein the synthetic retinyl ester is prophylactically administered to the human subject.

10. A method of ameliorating or restoring photoreceptor function in a human eye, comprising:

administering an effective amount of a synthetic retinal derivative to a human subject with a deficiency in endogenous 11-cis-retinal in the eye, and wherein when the synthetic retinal derivative is administered to the human subject a functional opsin/chromophore complex is formed in the eye; and

wherein the synthetic retinal derivative has a structure according to Formula I, II, Ill, IV, V, VI, VII, VIII, IX, X, XI, XII, XIII, XIV, XV or XVI.

11. The method of claim 10 , wherein the endogenous 11-cis retinal deficiency is associated with Retinitis Pigmentosa (RP), Leber Congenital Amaurosis (LCA), Retinitis Punctata Albesciens, Congenital Stationary Night Blindness, Fundus Albipunctatus, Age-Related Macular Degeneration, loss of night vision or contrast sensitivity.

12. The method of claim 10 , wherein the human subject has a mutation selected from an RPE65 mutation and an LRAT mutation.

13. The method of claim 10 , wherein the synthetic retinal derivative is a synthetic retinyl ester.

14. The method of claim 13 , wherein the synthetic retinyl ester is a 9-cis-retinyl ester or an 11-cis-retinyl ester.

15. The method of claim 14 , wherein synthetic retinyl ester comprises a carboxylate radical of a C 1 to C 10 monocarboxylic acid or a C 2 to C 22 polycarboxylic acid.

16. The method of claim 15 , wherein the synthetic retinyl ester is 9-cis-retinyl acetate or 9-cis-retinyl succinate.

17. The method of claim 15 , wherein the synthetic retinyl ester is 11-cis-retinyl acetate or 11-cis-retinyl succinate.

18. The method of claim 10 , wherein the synthetic retinal derivative is locally administered by eye drops, intraocular injection or periocular injection to the human subject.

19. The method of claim 10 , wherein the synthetic retinal derivative is orally administered to the human subject.

20. The method of claim 19 , wherein the synthetic retinal derivative is orally administered at a dose of about 1.0 to about 1000 mg.

21. The method of claim 20 , wherein the synthetic retinal derivative is orally administered at a dose of about 10 to about 250 mg.

22. The method of claim 10 , wherein the synthetic retinal derivative is administered to the human subject by intravenous injection or intramuscular injection.

23. The method of claim 2 , wherein the synthetic retinyl ester is 9-cis-retinyl succinate or 11-cis-retinyl succinate.

24. The method of claim 3 , wherein the synthetic retinyl ester is 9-cis-retinyl acetate or 11-cis-retinyl acetate.

25. The method of claim 8 , wherein the synthetic retinyl ester is orally administered at a dose of about 1.0 to about 1000 mg.

26. The method of claim 25 , wherein the synthetic retinyl ester is orally administered at a dose of about 10 to about 250 mg.

Assignments (2)
CONFIRMATORY LICENSE Recorded Jun 10, 2016
From: UNIVERSITY OF WASHINGTON
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 038955/0413 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 6, 2016
From: PALCZEWSKI, KRZYSZTOF; BATTEN, MATTHEW
To: UNIVERSITY OF WASHINGTON
Reel/Frame 037422/0414 →
Continuity (4)
Continuation 13042308 · Mar 7, 2011
Continuation 11629875
Provisional Application 60580889 · Jun 18, 2004
Related Publication 20130072560A1 · Mar 21, 2013