IP Library Granted Patent US 11,738,012
Granted Patent B2
US 11,738,012 · App. 16/078,929 · Granted Aug 29, 2023

Treatment of neurodegenerative eye disease using pridopidine

Inventors: Hermann Kurt Russ (Altendorf, CH); Michal Geva (Even-yehuda, IL); Ralph Laufer (Tel Aviv, IL); Aric Orbach (Rehovot, IL)
Assignee: PRILENIA NEUROTHERAPEUTICS LTD.
A61K31/451A61K45/06A61P27/02A61P27/06
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Quick Facts
Patent No.
US 11,738,012
App. No.
16/078,929
Granted
Aug 29, 2023
Kind
B2
Abstract

The subject invention provides a method of treating a subject afflicted with a neurodegenerative eye disease comprising administering to the subject an amount of pridopidine effective to treat the subject.

Claims (42)

1. A method of treating a human subject afflicted with a neurodegenerative eye disease comprising administering to the subject an amount of pridopidine effective to treat the subject, wherein the pridopidine is administered via a systemic administration in an amount of pridopidine administered is 100 mg/day-315 mg/day, or via a local administration to the eye in an amount of 0.1 mg/day-50 mg/day.

2. The method of claim 1 , wherein the administration of pridopidine is effective to reduce or inhibit a symptom of the neurodegenerative eye disease in the subject.

3. The method of claim 1 , wherein the neurodegenerative eye disease is selected from the group consisting of glaucoma, Age-related Macular Degeneration, optic neuropathy, and retinitis pigmentosa.

4. The method of claim 3 , wherein the neurodegenerative eye disease is Wet Age-related Macular Degeneration (“Wet AMD”) or Dry Age-related Macular Degeneration (“Dry AMD”).

5. The method of claim 3 , wherein the neurodegenerative eye disease is Leber hereditary optic neuropathy.

6. The method of claim 3 , wherein the neurodegenerative eye disease is glaucoma.

7. The method of claim 2 , wherein the symptom is retinal ganglion cell damage or retinal ganglion cell loss.

8. The method of claim 1 , wherein the amount of pridopidine is effective to reduce or prevent retinal ganglion cell loss or damage in the subject.

9. The method of claim 8 , wherein the retinal ganglion cell loss is reduced by at least 10%, by at least 20%, by at least 30%, by at least 40% or by at least 50%.

10. The method of claim 8 , wherein the retinal ganglion cell loss is reduced by more than 50%, more than 60%, more than 70%, or more than 80%.

11. The method of claim 1 , wherein the amount of pridopidine is effective to improve retinal ganglion cell viability in a subject.

12. The method of claim 1 , wherein the amount of pridopidine is effective to protect a retinal ganglion cell from cell death in the subject.

13. The method of claim 12 , wherein the cell death is induced by elevated intraocular pressure.

14. The method of claim 1 , wherein treating comprises slowing progression of the neurodegenerative disease of the eye in the subject.

15. The method of claim 1 , wherein treating comprises slowing progression of visual field loss towards blindness in a subject afflicted with glaucoma.

16. The method of claim 1 , wherein treating comprises preventing blindness in a subject afflicted with glaucoma.

17. The method of claim 1 , wherein the treating comprises reducing axonal degeneration in the subject.

18. The method of claim 1 , wherein pridopidine is pridopidine hydrochloride.

19. The method of claim 1 , wherein the pridopidine is administered via a systemic administration.

20. The method of claim 19 , wherein the pridopidine is administered in the form of an aerosol, an inhalable powder, an injectable, a liquid, a gel, a solid, a capsule or a tablet.

21. The method of claim 1 , wherein the pridopidine is administered via a local administration to the eye.

22. The method of claim 21 , wherein the pridopidine is administered in the form of a liquid, a gel, a cream or a contact lens.

23. The method of claim 21 , wherein the pridopidine is administered in the form of eye drops, an intraocular depot injection, eye gels, a tablet inserted into the conjunctiva, or a lens loaded with pridopidine.

24. The method of claim 19 wherein the amount of pridopidine administered is 100 mg/day-250 mg/day or 100 mg/day-180 mg/day.

25. The method of claim 21 , wherein the amount of pridopidine administered in a dose is 0.2 mg-20 mg.

26. The method of claim 1 , wherein the pridopidine is administered periodically.

27. The method of claim 26 , wherein pridopidine is administered daily.

28. The method of claim 26 , wherein pridopidine is administered more often than once daily or less often than once daily.

29. The method of claim 26 , wherein pridopidine is administered twice daily or thrice daily.

30. The method of claim 26 , wherein pridopidine is administered every other day or weekly.

31. The method of claim 26 , wherein the periodic administration of pridopidine continues for at least 3 days, more than 30 days, more than 42 days, 8 weeks or more, at least 12 weeks, at least 24 weeks, more than 24 weeks, 6 months or more, more than 12 months, more than 18 months, or more than 24 months.

32. The method of claim 1 , wherein the subject is a human patient.

33. The method of claim 1 , further comprising the administration of a second agent for the treatment of the neurodegenerative eye disease to the subject.

34. The method of claim 33 , wherein the second agent is a β-adrenergic antagonist, adrenergic agonist, parasympathomimetic, agonist prostaglandin analog, or carbonic anhydrase inhibitor.

35. The method of claim 33 , wherein the second agent reduces elevated intraocular pressure in a subject.

36. The method of claim 35 , wherein the second agent is a prostaglandin agonist, a beta blocker, a carbonic anhydrase inhibitor, an alpha agonist, or a combination thereof.

37. The method of claim 35 , wherein the second agent is latanoprost, bimatoprost, travoprost ophthalmic, unoprostone ophthalmic, tafluprost, Betaxolol ophthalmic, Carteolol, timolol, levobunolol, metipranolol, Dorzolamide, brinzolamide, acetazolamide, methazolamide, brimonidine, Apraclonidine, or a combination thereof.

38. The method of claim 33 , wherein the subject is administered a fixed-dose combination comprising pridopidine and the second agent.

39. The method of 19 , wherein the amount of pridopidine administered is 100 mg/day-180 mg/day.

40. The method of claim 19 , wherein the pridopidine is administered via an oral administration.

41. The method of claim 21 , wherein the pridopidine is administered via is a topical administration or via an intraocular, periocular, or ocular administration.

42. The method of claim 41 , wherein the pridopidine is administered by an eye drop application to the conjunctiva.

Assignments (4)
CHANGE OF ADDRESS Recorded Sep 11, 2023
From: PRILENIA NEUROTHERAPEUTICS LTD.
To: PRILENIA NEUROTHERAPEUTICS LTD.
Reel/Frame 064854/0167 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 13, 2023
From: RUSS, HERMANN KURT; GEVA, MICHAL; LAUFER, RALPH; ORBACH, ARIC
To: TEVA PHARMACEUTICALS INTERNATIONAL GMBH
Reel/Frame 064573/0319 →
CHANGE OF NAME Recorded Jul 23, 2019
From: PRILENIA THERAPEUTICS DEVELOPMENT LTD.
To: PRILENIA NEUROTHERAPEUTICS LTD.
Reel/Frame 049827/0527 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2018
From: TEVA PHARMACEUTICALS INTERNATIONAL GMBH
To: PRILENIA THERAPEUTICS DEVELOPMENT LTD.
Reel/Frame 047716/0148 →