Ophthalmic composition
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.
1. A method of treating progression of myopia or reducing the progression rate of myopia in an individual in need thereof, comprising administering to an eye of the individual (a) an aqueous solution comprising atropine or atropine sulfate and less than about 10% of a degradant of atropine or atropine sulfate formed from degradation of the atropine or atropine sulfate and (b) a buffering agent.
2. The method of claim 1 , wherein the atropine or atropine sulfate is present in the aqueous solution at a concentration of from about 0.01 mg/g to about 0.5 mg/g, 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 method of claim 1 , wherein the atropine or atropine sulfate is present in the aqueous solution 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 method of claim 1 , wherein the buffering agent 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 method of claim 1 , wherein the buffering agent comprises sodium dihydrogen phosphate, disodium hydrogen phosphate, or a combination thereof.
6. The method of claim 1 , wherein the aqueous solution further comprises a tonicity adjusting agent.
7. The method of claim 6 , wherein the tonicity adjusting agent comprises a halide salt of a monovalent cation.
8. The method of claim 1 , wherein the aqueous solution further comprises a viscosity agent.
9. The method of claim 8 , wherein the viscosity agent comprises hydroxyethyl cellulose, hydroxypropyl cellulose, or hydroxypropylmethyl-cellulose (HPMC).
10. The method of claim 1 , wherein the aqueous solution is substantially free of a preservative.
11. The method of claim 1 , wherein the aqueous solution further comprises a preservative.
12. The method of claim 11 , wherein a concentration of the preservative is from about 0.0001% to about 1%.
13. The method of claim 11 , wherein the preservative is selected from benzalkonium chloride, cetrimonium, sodium perborate, stabilized oxychloro complex, polyquaternium-1, chlorobutanol, edetate disodium, polyhexamethylene biguanide, or combinations thereof.
14. The method of claim 1 , wherein the aqueous solution is essentially free of procaine and benactyzine, or pharmaceutically acceptable salts thereof.
15. The method of claim 1 , wherein the aqueous solution is sterile.
16. The method of claim 1 , wherein the aqueous solution has a pH of from about 3.8 to about 6.4.
17. The method of claim 1 , wherein the aqueous solution is an ophthalmic composition.
18. The method of claim 1 , wherein the aqueous solution is administered at least once a day.
19. The method of claim 1 , wherein the aqueous solution is administered once a day.
20. The method of claim 1 , wherein the aqueous solution has a pH of less than 5.
21. The method of claim 1 , wherein the aqueous solution further comprises a stabilizing agent.
22. The method 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 method of claim 22 , wherein the stabilizing agent is EDTA.