|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)|
1. A first ophthalmic composition for the treatment of glaucoma or elevated intraocular pressure comprising about 0.01% w/v bimatoprost, about 200 ppm benzalkonium chloride,
about 0.268% w/v dibasic sodium phosphate heptahydrate, about 0.014% w/v citric acid monohydrate, about 0.81% w/v sodium chloride, and water, wherein administration thereof results in a lower incidence of one or more adverse events as compared to the
administration of a second ophthalmic composition comprising 0.03% w/v bimatoprost and 50 ppm benzalkonium chloride, and wherein the one or more adverse events are selected from the group consisting of macroscopic hyperemia, conjunctival hyperemia,
corneal abnormalities, and punctate keratitis.
2. The composition of claim 1 wherein the concentration of benzalkonium chloride is 200 ppm.
3. The composition of claim 2 having a pH of 7.3 which consists essentially of 0.01% w/v bimatoprost, 200 ppm benzalkonium chloride, 0.268% w/v dibasic sodium phosphate heptahydrate, 0.014% w/v citric acid monohydrate, 0.81% w/v sodium chloride, one or more selected from the group of sodium hydroxide and hydrochloric acid, and water.
4. A method comprising administering to a mammal suffering from glaucoma or intraocular hypertension the composition of claim 1.
5. The composition of claim 1 or 3, wherein the adverse event is macroscopic hyperemia.
6. The composition of claim 1 or 3, wherein the adverse event is conjunctival hyperemia.
7. The composition of claim 1 or 3, wherein the adverse event is corneal abnormalities.
8. The composition of claim 1 or 3, wherein the adverse event is punctate keratitis.