Claims for Patent: 8,829,005

Summary for Patent: 8,829,005

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:	Aciex Therapeutics, Inc. (Boston, MA)
Application Number:	13/899,321
Patent Claims:	1. A method for alleviating a sign or symptom of allergic conjunctivitis by topically administering to an eye of a subject in need thereof an ophthalmic formulation comprising a single active ingredient consisting of 0.24% (w/v) cetirizine twice daily, wherein the ophthalmic formulation a) does not contain a cyclodextrin; b) comprises 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, 0.01% Benzalkonium Chloride, NF, and Purified Water, USP; and c) has a pH 6.8-7.2. 2. The method of claim 1, wherein ophthalmic formulation is an aqueous formulation, an ointment, an oil, a suspension, an emulsion, or incorporated in a drug delivery device. 3. The method of claim 1, wherein the sign or symptom is itching. 4. The method of claim 1, wherein said subject has ocular itching, ocular redness and lid swelling. 5. The method of claim 1, wherein said subject has severe ocular itching, severe ocular redness or severe lid swelling. 6. The method of claim 1, wherein said composition is comfortable upon instillation. 7. The method of claim 1, wherein the sign or symptom is a nasal sign or symptom. 8. The method of claim 7, wherein the nasal sign or symptom is nasal congestion, nasal itching, ear itching, palate itching, or runny nose (rhinorrhea).