Claims for Patent: 9,993,471

Summary for Patent: 9,993,471

Title:	Ophthalmic formulations of cetirizine and methods of use
Abstract:	The present invention provides stable topical formulations of cetirizine that provide a comfortable formulation when instilled in the eye and is effective in the treatment of allergic conjunctivitis and/or allergic conjunctivitis. The invention further provides methods of treating allergic conjunctivitis and/or allergic rhinoconjunctivitis in a subject in need of such treatment by topical application of the cetirizine formulations of the invention directly to the eye.
Inventor(s):	Abelson; Mark Barry (Andover, MA), Chapin; Matthew J. (Amesbury, MA), Gomes; Paul (Andover, MA), Minno; George (Windham, NH), Nice; Jackie (Medford, MA)
Assignee:	NICOX OPHTHALMICS, INC. (Fort Worth, TX)
Application Number:	15/456,249
Patent Claims:	1. A method for the treatment of the signs and symptoms of allergic conjunctivitis comprising topically administering to an eye of a subject in need thereof a topical ophthalmic formulation comprising 0.1% to 0.25% (w/v) cetirizine hydrochloride or dihydrochloride, wherein cetirizine is the only active agent in the formulation and the formulation is formulated in a vehicle comprising 1% Polyethylene Glycol 400, NF, 0.2% Dibasic Sodium Phosphate, Anhydrous, USP, 0.25% Hypromellose, USP, 0.1% Polysorbate 80, NF, 1.2% to 1.8% Glycerin, USP, 0.025% Edetate disodium, USP; 0.01% Benzalkonium Chloride, NF, and Purified Water, USP, wherein the formulation has a pH 7 and does not contain a cyclodextrin or other solubilizing compound. 2. The method of claim 1, wherein the signs and symptoms are ocular itching, ocular redness and lid swelling and associated nasal symptoms. 3. A method for the treatment of the signs and symptoms of allergic conjunctivitis comprising topically administering to an eye of a subject in need thereof a topical ophthalmic formulation consisting of 0.1% (w/v) cetirizine, 1% Polyethylene Glycol 400, NF, 0.2% Dibasic Sodium Phosphate, Anhydrous, USP, 0.25% Hypromellose, USP, 0.1% Polysorbate 80, NF, 1.8% Glycerin, USP, 0.025% Edetate disodium, USP; 0.025% Edetate disodium, 0.01% Benzalkonium Chloride, NF, and Purified Water, USP and wherein the formulation has a pH 7 and does not contain a cyclodextrin or other solubilizing compound. 4. The method according to claim 3 wherein the cetirizine is present as cetirizine hydrochloride or dihydrochloride. 5. The method according to claim 3, wherein the signs and symptoms are ocular itching, ocular redness and lid swelling and associated nasal symptoms. 6. The method according to claim 4, wherein the signs and symptoms are ocular itching, ocular redness and lid swelling and associated nasal symptoms.