A topical ophthalmic emulsion for treating an eye of a human, the topical ophthalmic emulsion comprising: cyclosporin A in an amount of about 0.05% by weight; castor oil in an amount of about 1.25% by weight; polysorbate 80 in an amount of about 1.0% by weight; acrylate/C10-30 alkyl acrylate cross-polymer in an amount of about 0.05% by weight; glycerine in an amount of about 2.2% by weight; sodium hydroxide; and water; wherein cyclosporin A is the only peptide present in the topical ophthalmic emulsion. view more

The topical ophthalmic emulsion of claim 18, wherein the topical ophthalmic emulsion is therapeutically effective in treating keratoconjunctivitis sicca.

The topical ophthalmic emulsion of claim 18, wherein the topical ophthalmic emulsion is therapeutically effective in increasing tear production.

A method of increasing tear production in the eye of a human, the method comprising topically administering to the eye of the human in need thereof an emulsion at a frequency of twice a day, wherein the emulsion comprises cyclosporin A in an amount of about 0.05% by weight, polysorbate 80, acrylate/C10-30 alkyl acrylate cross-polymer, water, and castor oil in an amount of about 1.25% by weight; and wherein the topical ophthalmic emulsion is effective in increasing tear production. view more

The method of claim 1, wherein, when the emulsion is administered to an eye of a human in an effective amount in increasing tear production, the blood of the human has substantially no detectable concentration of cyclosporin A.

The method of claim 1, wherein the emulsion is as substantially therapeutically effective as a second emulsion administered to a human in need thereof at a frequency of twice a day, the second emulsion comprising cyclosporin A in an amount of 0.1% by weight and castor oil in an amount of 1.25% by weight. view more

The method of claim 1, wherein the emulsion achieves at least as much therapeutic effectiveness as a second emulsion administered to a human in need thereof at a frequency of twice a day, the second emulsion comprising cyclosporin A in an amount of 0.1% by weight and castor oil in an amount of 1.25% by weight. view more

A method comprising: administering an emulsion topically to the eye of a human having keratoconjunctivitis sicca at a frequency of twice a day, wherein the emulsion comprises: cyclosporin A in an amount of about 0.05% by weight; castor oil in an amount of about 1.25% by weight; polysorbate 80 in an amount of about 1.0% by weight; acrylate/C10-30 alkyl acrylate cross-polymer in an amount of about 0.05% by weight; glycerine in an amount of about 2.2% by weight; sodium hydroxide; and water; and wherein the emulsion is effective in increasing tear production in the human having keratoconjunctivitis sicca. view more

The method of claim 22, wherein the emulsion has a pH in the range of about 7.2 to about 7.6.

A topical ophthalmic emulsion for increasing tear production in an eye of a human having keratoconjunctivitis sicca, wherein the topical ophthalmic emulsion comprises cyclosporin A in an amount of about 0.05% by weight, polysorbate 80, acrylate/C10-30 alkyl acrylate cross-polymer, water, and castor oil in an amount of about 1.25% by weight; and wherein the topical ophthalmic emulsion is therapeutically effective in increasing tear production in the eye of the human having keratoconjunctivitis sicca. view more

The topical ophthalmic emulsion of claim 25, wherein, when the topical ophthalmic emulsion is administered to an eye of a human in an effective amount in increasing tear production in the eye of the human having keratoconjunctivitis sicca, the blood of the human has substantially no detectable concentration of cyclosporin A. view more

A method of enhancing tearing in a human eye, the method comprising topically administering to a human eye in need thereof a first topical ophthalmic emulsion at a frequency of twice a day, wherein the first topical ophthalmic emulsion comprises cyclosporin A in an amount of about 0.05% by weight, polysorbate 80, acrylate/C10-30 alkyl acrylate cross-polymer, water, and castor oil in an amount of about 1.25% by weight; wherein the method is therapeutically effective in treating dry eye disease and wherein the method achieves at least as much therapeutic efficacy as administration of a second topical ophthalmic emulsion to a human eye in need thereof at a frequency of twice a day, the second emulsion comprising cyclosporin A in an amount of about 0.1% by weight and castor oil in an amount of about 1.25% by weight; and wherein the method results in a concentration of cyclosporin A in the blood of the human of less than about 0.1 ng/ml. view more

The method of claim 13, wherein the method is effective in enhancing lacrimal gland tearing.

A method of restoring tearing, the method comprising topically administering to a human eye in need thereof a first topical ophthalmic emulsion at a frequency of twice a day, wherein the first topical ophthalmic emulsion comprises cyclosporin A in an amount of about 0.05% by weight, polysorbate 80, acrylate/C10-30 alkyl acrylate cross-polymer, water, and castor oil in an amount of about 1.25% by weight; wherein the method demonstrates a reduction in adverse events in the human, compared to administration of a second topical ophthalmic emulsion to a human eye in need thereof at a frequency of twice a day, the second topical ophthalmic emulsion comprising cyclosporin A in an amount of about 0.1% by weight and castor oil in an amount of about 1.25% by weight; and wherein the method achieves at least as much therapeutic efficacy as administration of the second topical ophthalmic emulsion to a human eye in need thereof at a frequency of twice a day. view more

The method of claim 21, wherein the method results in a concentration of cyclosporin A in the blood of the human of less than about 0.1 ng/ml.

The method of claim 21, wherein the method is effective in restoring lacrimal gland tearing.

The method of claim 21, wherein the adverse events are selected from the group consisting of visual distortion and eye irritation and wherein the method results in a concentration of cyclosporin A in the blood of the human of less than about 0.1 ng/ml. view more