IP Library Granted Patent US 11,890,277
Granted Patent B2
US 11,890,277 · App. 18/055,940 · Granted Feb 6, 2024

Ophthalmic composition

Inventors: Gregory I. Ostrow (San Diego, CA); Kenneth J. Widder (Rancho Santa Fe, CA); David S. Baker (Carlsbad, CA)
Assignee: SYDNEXIS, INC.
A61K31/46A61K9/0048A61K47/02
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Quick Facts
Patent No.
US 11,890,277
App. No.
18/055,940
Granted
Feb 6, 2024
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 (20)

1. A stabilized ophthalmic composition for treating pre-myopia, myopia, or progression of myopia, comprising from about 0.001 wt % to about 0.05 wt % of atropine or atropine sulfate and deuterated water, wherein the stabilized ophthalmic composition further comprises a buffering agent at a pD from about 4.2 to about 7.9, wherein the stabilized ophthalmic composition is a liquid, wherein the buffering agent has a buffer capacity sufficient to maintain the pD of the solution between about 4.2 to about 7.9 for an extended period of time of at least 1 month.

2. The stabilized ophthalmic composition of claim 1 , wherein the buffering agent has a pD from about 4.2 to about 6.8, wherein the buffering agent has a buffer capacity sufficient to maintain the pD of the solution between about 4.2 to about 6.8 for an extended period of time of at least 1 month.

3. The stabilized ophthalmic composition of claim 1 , further comprising noratropine, atropine-N-oxide, tropine, tropic acid, hyoscine, scopolamine, tropicamide, cyclopentolate, pirenzepine, homatropine, or a combination thereof.

4. The stabilized ophthalmic composition of claim 1 , wherein the atropine or atropine sulfate is present in the composition at a concentration of from about 0.001 wt % to about 0.03 wt %.

5. The stabilized ophthalmic composition of claim 1 , wherein the atropine or atropine sulfate is present in the composition at a concentration of from about 0.001 wt % to about 0.02 wt %.

6. The stabilized ophthalmic composition of claim 1 , wherein the atropine or atropine sulfate is present in the composition at a concentration of from about 0.001 wt % to about 0.01 wt %.

7. The stabilized ophthalmic composition of claim 1 , wherein the buffering agent comprises an acetate buffering agent, a citrate buffering agent, a carbonate buffering agent, an organic buffering agent, an amino acid buffering agent, or a combination thereof.

8. The stabilized ophthalmic composition of claim 1 , wherein the buffering agent comprises an acetate buffering agent or a citrate buffering agent, or a combination thereof.

9. The stabilized ophthalmic composition of claim 1 , wherein the stabilized ophthalmic composition further comprises a tonicity adjusting agent.

10. The stabilized ophthalmic composition of claim 9 , wherein the tonicity adjusting agent comprises a halide salt of a monovalent cation.

11. The stabilized ophthalmic composition of claim 1 , further comprising an ophthalmically acceptable viscosity agent.

12. The stabilized ophthalmic composition of claim 11 , wherein the ophthalmically acceptable viscosity agent comprises hydroxyethyl cellulose, hydroxypropyl cellulose, or hydroxypropylmethyl-cellulose (HPMC).

13. The stabilized ophthalmic composition of claim 1 , further comprising a preservative.

14. The stabilized ophthalmic composition of claim 13 , wherein a concentration of the preservative is from about 0.00010% to about 1%.

15. The stabilized ophthalmic composition of claim 13 , wherein the preservative is selected from benzalkonium chloride, certrimonium, sodium perborate, stabilized oxychloro complex, polyquaternium-1, chlorobutanol, edetate disodium, polydexamethylene biguanide, or combinations thereof.

16. The stabilized ophthalmic composition of claim 1 , wherein the stabilized ophthalmic composition is essentially free of procaine and benactyzine, or pharmaceutically acceptable salts thereof.

17. A method of treating the pre-myopia, myopia or progression of myopia in an individual in need thereof, comprising administering to an eye of the individual an effective amount of the stabilized ophthalmic composition of claim 1 .

18. The method of claim 17 , wherein the stabilized ophthalmic composition is administered topically.

19. The method of claim 17 , wherein the stabilized ophthalmic composition is administered by instillation.

20. The method of claim 17 , wherein the stabilized ophthalmic composition is administered through an eye drop bottle containing the stabilized ophthalmic composition.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 28, 2023
From: OSTROW, GREGORY I.; WIDDER, KENNETH J.; BAKER, DAVID S.
To: SYDNEXIS, INC.
Reel/Frame 065975/0717 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 16, 2022
From: OSTROW, GREGORY I.; WIDDER, KENNETH J.; BAKER, DAVID S.
To: SYDNEXIS, INC.
Reel/Frame 061791/0872 →
Continuity (10)
Continuation 17097930 · Nov 13, 2020
Continuation 16224286 · Dec 18, 2018
Continuation 15895933 · Feb 13, 2018
Continuation 15661816 · Jul 27, 2017
Continuation 15208537 · Jul 12, 2016
Continuation 14726139 · May 29, 2015
Provisional Application 62151926 · Apr 23, 2015
Provisional Application 62096433 · Dec 23, 2014
Provisional Application 62016502 · Jun 24, 2014
Related Publication 20230093205A1 · Mar 23, 2023
Cited By (1)
US 12,629,360