Hypertonic dextran solution and methods of treating and preventing recurrent corneal erosion

• US 9,351,990 B2
• Filed: 08/16/2013
• Issued: 05/31/2016
• Est. Priority Date: 09/22/2011
• Status: Expired due to Fees

• Current Assignee: Theo Holdings, LLC
• Original Assignee: Theo Holdings, LLC
• Inventors: Szabocsik, John M.
• Primary Examiner(s): Maier, Leigh C
• Application Number:
  US13/969,032
• Publication Number:
  US 20140045786A1
• Time in Patent Office: 1,019 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61J 1/067 Flexible ampoules, the contents of which are expelled by squeezing
• CPC Class Codes: A61K 31/715 Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• CPC Class Codes: A61K 31/721 Dextrans
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

An ophthalmic solution is provided. The ophthalmic solution is hypertonic. The ophthalmic solution includes a polysaccharide having an average molecular weight of between about 40,000 grams per mole and about 150,000 grams per mole. A packaged ophthalmic solution for preventing the ophthalmic solution from being exposed to CO₂ and other contaminants is also provided. The ophthalmic solution can be used to treat recurrent corneal erosion. The ophthalmic solution can also be used as a prophylactic to prevent recurrent corneal erosion.

Claims

1. A method of treating a human eye for recurrent corneal erosion comprising:

topically administering to the human eye an ophthalmic solution for treating recurrent corneal erosion, the solution consisting of;

between about 5% and 25% by weight of a polymer of glucose having an average molecular weight of between about 40,000 grams per mole and about 150,000 grams per mole;

one or more inorganic salts including between about 0.5% and 2% by weight NaCl;

between about 0.5% and 2% by weight hyaluronic acid;

at least about 71% by weight water; and

less than about 360 ppm carbon dioxide;

wherein the ophthalmic solution has a pH between about 6.5 and 7.5 and has an osmolality of between about 320-350 mOsmol/kg solution;

wherein the human eye to which the ophthalmic solution is administered suffers from recurrent corneal erosion; and

wherein the ophthalmic solution is administered to the eye about every 3 to 8 hours for about 2 to 16 weeks.

2. The method of claim 1 further comprising obtaining the ophthalmic solution from a plastic ampoule in a sealed foil pouch;

wherein the sealed foil pouch has an interior closed to the external atmosphere and provides a carbon dioxide and oxygen barrier preventing atmospheric carbon dioxide from entering the interior of the sealed foil pouch;

wherein the sealed foil pouch is opened within about 30 days prior to the administering.

3. The method of claim 1, wherein the polymer of glucose is dextran and has an average molecular weight of about 70,000 grams per mole.

4. The method of claim 3, wherein the dextran is present in a concentration of between about 8% and 12% by weight of dextran.

5. The method of claim 1, wherein the ophthalmic solution is administered about every 3 to 4 hours for about 7 to 10 weeks.

6. The method of claim 1, wherein the ophthalmic solution is administered at least 5 times daily for at least 8 weeks.

7. The method of claim 1, wherein the ophthalmic solution has less than about 100 ppm carbon dioxide.

8. The method of claim 1, wherein the dose of ophthalmic solution for each administration is between about 0.2 and 0.5 ml.

9. The method of claim 1, wherein the one or more inorganic salts further comprises potassium chloride, calcium chloride, magnesium chloride, a sulfate salt, a phosphate salt, a borate salt, a nitrate salt, a citrate salt, or an acetate salt.

10. The method of claim 1, wherein the water is distilled.

11. The method of claim 1 wherein the hyaluronic acid is present in the solution at a concentration of between about 0.75% and 1.5% by weight.

12. The method of claim 1 wherein the NaCl is present in the solution at a concentration of between about 0.7% and 1.2% by weight.

13. The method of claim 1 wherein the ophthalmic solution has a colloidal osmolality at least equal to the colloidal osmolality of the deturgescent cornea.