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Claims for Patent: 8,586,630

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Claims for Patent: 8,586,630

Title:Enhanced bimatoprost ophthalmic solution
Abstract: A composition comprising from 0.005% to 0.02% bimatoprost by weight and from 100 ppm to 250 ppm benzalkonium chloride, wherein said composition is an aqueous liquid which is formulated for ophthalmic administration is disclosed herein. A method which is useful in treating glaucoma or ocular hypertension related thereto is also disclosed herein.
Inventor(s): Chang; Chin-Ming (Tustin, CA), Chang; James N. (Newport Beach, CA), Schiffman; Rhett M. (Laguna Beach, CA), Jordan; R. Scott (Trabuco Canyon, CA), Chang-Lin; Joan-En (Tustin, CA)
Assignee: Allergan, Inc. (Irvine, CA)
Application Number:13/715,332
Patent Claims: 1. A method of reducing intraocular pressure in patients with open angle glaucoma or ocular hypertension comprising applying to the eyes of the patient an aqueous composition comprising: about 0.01%-0.015% w/v bimatoprost; about 200 ppm benzalkonium chloride; and, water.

2. The method of claim 1 wherein the bimatoprost is present in a concentration of 0.01% w/v.

3. The method of claim 1 wherein the method results in reduced side effects as compared to an aqueous composition comprising 0.03% w/v bimatoprost and 50 ppm benzalkonium chloride.

4. The method of claims 1 and 2 wherein the patient applies the aqueous solution once a day.

5. The method of claim 3 wherein the reduced side effects include a lower incidence of hyperemia.

6. A method of reducing intraocular pressure in patients with open angle glaucoma or ocular hypertension comprising applying to the eyes of the patient an aqueous composition comprising: 0.01%-0.015% w/v bimatoprost; about 200 ppm benzalkonium chloride; the solution having a pH of about 7.3; a citric acid buffer; and, water.

7. The method of claim 6 wherein the method is applied to patients suffering from glaucoma.

8. The method of claim 6 wherein the citric acid buffer is present in a concentration of about 0.014% w/v.

9. The method of claim 6 wherein the method is applied once a day.

10. The method of claim 7 wherein the glaucoma is open angle glaucoma.

11. The method of claim 6 wherein the solution comprises 200 ppm benzalkonium chloride.

12. A method of reducing intraocular pressure in patients with open angle glaucoma or ocular hypertension comprising applying to the eyes of the patient an aqueous composition comprising the following step: applying at least once a day a formulation comprising: about 0.01%-0.15% w/v bimatoprost; a preservative benzalkonium chloride in the amount of about 200 ppm; at least one buffering agent selected from the group consisting of dibasic sodium phosphate heptahydrate, citric acid monohydrate and EDTA; and wherein the formulation has a pH of about 7.3.

13. The method of claim 12 wherein the formulation is an aqueous solution.

14. The method of claim 12 wherein the formulation is an emulsion.

15. The method of claim 12 wherein the buffering agent is dibasic sodium phosphate heptahydrate.

16. The method of claim 12 wherein the buffering agent is citric acid monohydrate.

17. The method of claim 12 wherein the buffering agent is EDTA.

18. The method of claim 13 further comprising purified water.

19. A method of reducing intraocular pressure in patients with open angle glaucoma or ocular hypertension comprising applying to the eyes of the patient an aqueous composition once a day an aqueous solution comprising: 0.01%-0.15% w/v bimatoprost; 0.02% w/v benzalkonium chloride; at least one buffering agents selected from the group consisting of dibasic sodium phosphate heptahydrate, citric acid monohydrate and EDTA; and, at least one selected from the group consisting of hydrochloric acid and sodium hydroxide to adjust the solution to a pH of about 7.3; and, purified water.

20. The method of claim 19 wherein the at least one buffering agents is citric acid monohydrate.
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