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Claims for Patent: 9,155,716

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Claims for Patent: 9,155,716

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:13/826,047
Patent Claims: 1. A method of lowering intraocular pressure in a person with glaucoma or ocular hypertension, the method comprising administering once daily to an eye of the person a first composition comprising about 0.01% w/v bimatoprost and about 0.02% w/v benzalkonium chloride, wherein the method lowers intraocular pressure as effectively and results in improved ocular surface tolerability as compared to the once daily administration of a second composition comprising 0.03% w/v bimatoprost and 0.005% w/v benzalkonium chloride.

2. The method of claim 1, wherein the first composition has a pH of about 7.3.

3. The method of claim 1, wherein the first composition comprises 0.01% w/v bimatoprost and 0.02% w/v benzalkonium chloride.

4. The method of claim 2 wherein the first composition has a pH of 7.3.

5. The method of claim 1 wherein the first composition results in less punctate keratitis as compared to the second composition.

6. The method of claim 1 wherein the first composition results in less hyperemia as compared to the second composition over a 12 month period.

7. The method of claim 1 wherein the first composition results in less macroscopic hyperemia as compared to the second composition.

8. The method of claim 1 wherein the first composition results in less moderate/severe hyperemia as compared to the second composition.

9. The method of claim 1 wherein the first composition is further comprised of sodium phosphate heptahydrate, citric acid monohydrate and water.

10. The method of claim 1 wherein the first composition is further comprised of sodium phosphate heptahydrate, citric acid monohydrate, water, sodium chloride and hydrochloric acid and sodium hydroxide to adjust the pH.

11. The method of claim 1 wherein the method results in less overall adverse events, ocular adverse events, overall treatment-related adverse events and ocular treatment-related adverse events as compared to the once daily administration of a second composition comprising 0.03% w/v bimatoprost and 0.005% w/v benzalkonium chloride.

12. The method of claim 10 wherein the first composition is further comprised of about 0.26% w/v dibasic sodium phosphate heptahydrate and about 0.8% w/v sodium chloride.
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