IP Library Granted Patent US 10,940,145
Granted Patent B2
US 10,940,145 · App. 16/785,418 · Granted Mar 9, 2021

Ophthalmic composition

Inventors: Gregory I. Ostrow (San Diego, CA); Kenneth J. Widder (Rancho Santa Fe, CA); David S. Baker (Carlsbad, CA); Harun Takruri (Newport Beach, CA)
Assignee: SYDNEXIS, INC.
A61K31/46A61K9/0048A61K47/02
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Quick Facts
Patent No.
US 10,940,145
App. No.
16/785,418
Granted
Mar 9, 2021
Kind
B2
Abstract

Provided herein is an ophthalmic composition. In some embodiments, the ophthalmic composition includes a low concentration of an ophthalmic agent for treatment of an ophthalmic disorder or condition; and an ophthalmically acceptable carrier, wherein the ophthalmic agent is distributed with substantial uniformity throughout the ophthalmically acceptable carrier. Further disclosed herein include an ophthalmic composition including a low concentration of an ophthalmic agent and deuterated water. Also disclosed herein are methods of arresting or preventing myopia development by administering to an eye of an individual in need thereof an effective amount of an ophthalmic composition as described herein.

Claims (28)

1. A kit comprising:

a. a vial comprising a pharmaceutical composition, the pharmaceutical composition comprising:

i. about 0.01 mg/g to about 0.5 mg/g of atropine or atropine sulfate;

ii. water; and

iii. a buffer; and

b. instructions for use.

2. The kit of claim 1 , wherein the atropine or atropine sulfate is present in the pharmaceutical composition at a concentration of from about 0.01 mg/g to about 0.3 mg/g or from about 0.1 mg/g to about 0.2 mg/g.

3. The kit of claim 1 , wherein the atropine or atropine sulfate is present in the pharmaceutical composition at a concentration of about 0.1 mg/g, about 0.2 mg/g, about 0.25 mg/g, about 0.3 mg/g, about 0.4 mg/g, or about 0.5 mg/g.

4. The kit of claim 1 , wherein the buffer comprises a borate, a borate-polyol complex, a phosphate buffering agent, a citrate buffering agent, an acetate buffering agent, a carbonate buffering agent, an organic buffering agent, an amino acid buffering agent, or a combination thereof.

5. The kit of claim 1 , wherein the buffer comprises sodium dihydrogen phosphate, disodium hydrogen phosphate, or a combination thereof.

6. The kit of claim 1 , wherein the pharmaceutical composition further comprises a tonicity adjusting agent.

7. The kit of claim 6 , wherein the tonicity adjusting agent comprises a halide salt of a monovalent cation.

8. The kit of claim 1 , wherein the pharmaceutical composition further comprises a viscosity agent.

9. The kit of claim 8 , wherein the viscosity agent comprises hydroxyethyl cellulose, hydroxypropyl cellulose, or hydroxypropylmethyl-cellulose (HPMC).

10. The kit of claim 1 , wherein the pharmaceutical composition is substantially free of a preservative.

11. The kit of claim 1 , wherein the pharmaceutical composition comprises less than about 1% of a preservative.

12. The kit of claim 1 , wherein the pharmaceutical composition further comprises a preservative.

13. The kit of claim 12 , wherein a concentration of the preservative is from about 0.0001% to about 1%.

14. The kit of claim 12 , wherein the preservative is selected from benzalkonium chloride, cetrimonium, sodium perborate, stabilized oxychloro complex, polyquaternium-1, chlorobutanol, edetate disodium, polyhexamethylene biguanide, or combinations thereof.

15. The kit of claim 1 , wherein the pharmaceutical composition is essentially free of procaine and benactyzine, or pharmaceutically acceptable salts thereof.

16. The kit of claim 1 , wherein the pharmaceutical composition has an acidic pH.

17. The kit of claim 1 , wherein the pharmaceutical composition has a pH of from about 3.8 to about 6.4.

18. The kit of claim 1 , wherein the pharmaceutical composition has a pH of less than 5.

19. The kit of claim 1 , wherein the pharmaceutical composition is a solution.

20. The kit of claim 1 , wherein the pharmaceutical composition is sterile.

21. The kit of claim 1 , wherein the pharmaceutical composition further comprises a stabilizing agent.

22. The kit of claim 21 , wherein the stabilizing agent is selected from the group consisting of glycerol, methionine, monothioglycerol, ethylenediaminetetraacetic acid (EDTA), ascorbic acid, polysorbate 80, polysorbate 20, arginine, heparin, dextran sulfate, cyclodextrins, pentosan polysulfate, magnesium, zinc and combinations thereof.

23. The kit of claim 22 , wherein the stabilizing agent is EDTA.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 19, 2020
From: OSTROW, GREGORY I.; WIDDER, KENNETH J.; BAKER, DAVID S.
To: SYDNEXIS, INC.
Reel/Frame 052992/0984 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 19, 2020
From: TAKRURI, HARUN
To: NEWPORT RESEARCH, INC.
Reel/Frame 052993/0048 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 19, 2020
From: NEWPORT RESEARCH, INC.
To: SYDNEXIS, INC.
Reel/Frame 052993/0183 →
Continuity (6)
Continuation 16677538 · Nov 7, 2019
Continuation 15568381
Continuation In Part PCTUS2015037249 · Jun 23, 2015
Continuation In Part 14726139 · May 29, 2015
Provisional Application 62151926 · Apr 23, 2015
Related Publication 20200297714A1 · Sep 24, 2020
Cited By (2)
US 12,213,912 US 12,629,360