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Claims for Patent: 8,933,127

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Claims for Patent: 8,933,127

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:13/551,362
Patent Claims: 1. A first composition administered once daily for lowering intraocular pressure in a person with glaucoma or ocular hypertension, the first composition comprising 0.01% w/v bimatoprost and 0.02% w/v benzalkonium chloride, wherein the first composition lowers intraocular pressure and results in less conjunctival hyperemia or less severe macroscopic hyperemia 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 composition of claim 1 wherein the first composition has a pH of about 7.3.

3. The composition of claim 1 wherein the first composition is effective in treating glaucoma.

4. The composition of claim 1 wherein the first composition is non-inferior in treating ocular hypertension at 15/17 timepoints in comparison to the second composition.

5. A first composition administered at least once daily for lowering intraocular pressure in a person with glaucoma or ocular hypertension, the first composition comprising about 0.01% w/v bimatoprost and about 0.02% w/v benzalkonium chloride, wherein the first composition results in a decrease in at least one ocular-related adverse event selected from the group consisting of macroscopic hyperemia, conjunctival hyperemia, punctate keratitis, and corneal abnormalities, and wherein the first composition lowers intraocular pressure without a substantial reduction in the intraocular pressure lowering benefit provided by the once daily administration of a second composition comprising about 0.03% w/v bimatoprost and about 0.005% w/v benzalkonium chloride.

6. The composition of claim 5 wherein the first composition has a pH of 7.3.

7. The composition of claim 5 wherein the first composition comprises 0.01% w/v bimatoprost and 0.02% w/v benzalkonium chloride.

8. The composition of claim 5 wherein the first composition has greater ocular surface tolerability than the second composition.

9. The composition of claim 5 wherein the first composition is effective in treating glaucoma.

10. The composition of claim 5 wherein the first composition is effective in treating ocular hypertension.

11. A first composition for reducing the amount of bimatoprost administered to a person in a once daily treatment for glaucoma or ocular hypertension, the first composition comprising 0.01% w/v bimatoprost and 0.02% w/v benzalkonium chloride, wherein the first composition remains useful in treating glaucoma or ocular hypertension despite a lower concentration of bimatoprost as compared to the once daily administration of a second composition comprising 0.03% w/v bimatoprost and 0.005% w/v benzalkonium chloride wherein the once daily administration of the first composition results in less hyperemia as compared to the once daily administration of the second composition.

12. The composition of claim 11 wherein the first composition has a pH of 7.3.

13. The composition of claim 11 wherein the first composition has improved ocular surface tolerability as compared to the second composition.

14. The composition of claim 11 wherein the first composition is a solution.

15. The composition of claim 11 wherein the first composition is effective in treating elevated intraocular pressure.

16. The composition of claim 11 wherein the first composition is effective at treating glaucoma.

17. The composition of claim 11 wherein the first composition is effective in treating ocular hypertension.

18. A first composition administered once daily for lowering intraocular pressure in a person with glaucoma or ocular hypertension, the first composition comprising 0.01% w/v bimatoprost and 0.02% w/v benzalkonium chloride, wherein the first composition lowers intraocular pressure and results in less adverse events, less hypermia and less 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.

19. The composition of claim 18 wherein the first composition is effective at treating glaucoma.

20. The composition of claim 18 wherein the first composition is effective in treating ocular hypertension.

21. The composition of claim 18 wherein the first composition is equivalent in efficacy to the second composition over a three month period.
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