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Generated: September 24, 2017

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Title:Combination of brimonidine and timolol for topical ophthalmic use
Abstract: Disclosed are pharmaceutical compositions comprising brimondine and timolol for topical ophthalmic delivery and a method of treatment comprising administering said composition when indicated for glaucoma and associated conditions such as elevated intraocular pressure in the eyes of humans.
Inventor(s): Chang; Chin-Ming (Tustin, CA), Beck; Gary J. (Fullerton, CA), Pratt; Cynthia C. (Mission Viejo, CA), Batoosingh; Amy L. (Mission Viejo, CA)
Assignee: Allergan, Inc. (Irvine, CA)
Application Number:13/308,507
Patent Claims: 1. A pharmaceutical composition comprising: brimonidine at a concentration of 0.2% w/v, and timolol at a concentration of 0.5% w/v in a single composition, wherein the composition is sterile and is suitable for topical ophthalmic use.

2. The composition of claim 1, further comprising a phosphate buffer.

3. The composition of claim 2, further comprising about 0.005% benzalkonium chloride.

4. The composition of claim 1, wherein the brimonidine is brimonidine tartrate.

5. The composition of claim 1, wherein the brimonidine is brimonidine free base.

6. The composition of claim 1, wherein the timolol is timolol maleate.

7. The composition of claim 1, wherein the timolol is timolol free base.

8. The composition of claim 1, having a pH of about 6.9.

9. The composition of claim 1, further comprising carboxymethyl cellulose at a concentration of about 0.01% w/v to about 2% w/v.

10. A method of reducing intraocular pressure in a patient with elevated intraocular pressure or glaucoma comprising administering a composition of claim 1 to an eye the patient.

11. The method of claim 10, wherein the composition is administered two times a day.

12. The method of claim 10, wherein the method results in a lower incidence of conjunctival hyperemia as compared to administration of brimonidine three times a day without the concurrent administration of timolol.

13. The method of claim 10, wherein the method results in a lower incidence of visual disturbance as compared to administration of brimonidine three times a day without the concurrent administration of timolol.

14. The method of claim 10, wherein the method results in a lower incidence of epiphora as compared to administration of brimonidine three times a day without the concurrent administration of timolol.

15. The method of claim 10, wherein the method results in a lower incidence of oral dryness as compared to administration of brimonidine three times a day without the concurrent administration of timolol.

16. The method of claim 10, wherein the method results in a lower incidence of eye pruritus as compared to administration of brimonidine three times a day without the concurrent administration of timolol.

17. The method of claim 10, wherein the method results in a lower incidence of allergic conjunctivitis as compared to administration of brimonidine three times a day without the concurrent administration of timolol.

18. The method of claim 10, wherein the method results in a lower incidence of asthenia as compared to administration of brimonidine three times a day without the concurrent administration of timolol.

19. The method of claim 10, wherein the method results in a lower incidence of foreign body sensation as compared to administration of brimonidine three times a day without the concurrent administration of timolol.

20. The method of claim 10, wherein the method results in a lower incidence of conjunctival folliculosis as compared to administration of brimonidine three times a day without the concurrent administration of timolol.

21. The method of claim 10, wherein the method results in a lower incidence of somnolence as compared to administration of brimonidine three times a day without the concurrent administration of timolol.
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Serving 500+ biopharmaceutical companies globally:

Citi
US Department of Justice
Baxter
US Army
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Novartis
Federal Trade Commission
Fuji
Argus Health

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