IP Library Granted Patent US 10,675,279
Granted Patent B2
US 10,675,279 · App. 16/001,679 · Granted Jun 9, 2020

Ophthalmic formulations of cetirizine and methods of use

Inventors: Mark Barry Abelson (Andover, MA); Matthew J. Chapin (Amesbury, MA); Paul Gomes (Andover, MA); George Minno (Windham, NH); Jackie Nice (Medford, MA)
Assignee: NICOX OPTHALMICS, INC.
A61K31/495A61K9/0048A61K9/08A61K31/4174A61K31/4965A61K31/56A61K31/569A61K47/02A61K47/10A61K47/183A61K47/186A61K47/26A61K47/38
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Quick Facts
Patent No.
US 10,675,279
App. No.
16/001,679
Granted
Jun 9, 2020
Kind
B2
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.

Claims (16)

1. A method for the treatment of signs and symptoms of allergic conjunctivitis and/or rhinoconjunctivitis, the method comprising topically administering to an eye of a subject in need thereof a topical ophthalmic formulation comprising cetirizine at a concentration of from 0.05% to 0.5% (w/v) and naphazoline at a concentration of from 0.01% to 0.5% (w/v).

2. The method according to claim 1 wherein the symptoms of allergic conjunctivitis are ocular itching, redness and eyelid swelling, and nasal symptoms.

3. A method for the treatment of signs and symptoms of allergic conjunctivitis, the method comprising topically administering to an eye of a subject in need thereof a topical ophthalmic formulation comprising:

cetirizine at a concentration of from 0.05% to 0.25% (w/v);

naphazoline at a concentration of from 0.01% to 0.2% (w/v); and

hydroxypropylmethyl cellulose or carboxymethyl cellulose at a concentration of from 0.5% to 1% (w/v), wherein:

the formulation has a viscosity of 60-80 cpi, the formulation does not contain cyclodextrin, and the formulation has a pH of from 5.0 to 7.5.

4. The method according to claim 3 wherein the symptoms of allergic conjunctivitis are ocular itching, redness and eyelid swelling, and associated nasal symptoms.

5. A method for the treatment of signs and symptoms of allergic conjunctivitis and/or rhinoconjunctivitis, the method comprising topically administering to an eye of a subject in need thereof a topical ophthalmic formulation comprising cetirizine at a concentration of from 0.05% to 0.25% (w/v) and oxymetazoline at a concentration of from 0.01% to 0.2% (w/v).

6. The method according to claim 5 wherein the symptoms of allergic conjunctivitis are ocular itching, redness and eyelid swelling, and associated nasal symptoms.

7. A method for the treatment of signs and symptoms of allergic conjunctivitis and/or rhinoconjunctivitis, the method comprising topically administering to an eye of a subject in need thereof a topical ophthalmic formulation comprising:

cetirizine at a concentration of from 0.01% to 0.25% (w/v);

oxymethazoline at a concentration of from 0.01% to 0.1% (w/v); and

hydroxypropylmethyl cellulose or carboxymethyl cellulose at a concentration of from 0.5% to 1% (w/v),

wherein the formulation has a viscosity of 60-80 cpi, the formulation does not contain cyclodextrin, and the formulation has a pH of from 5.0 to 7.5.

8. The method according to claim 7 wherein the symptoms of allergic conjunctivitis are ocular itching, redness and eyelid swelling, and nasal symptoms.

Assignments (3)
CHANGE OF ADDRESS Recorded May 11, 2020
From: NICOX OPHTHALMICS, INC
To: NICOX OPHTHALMICS, INC
Reel/Frame 052628/0538 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 8, 2018
From: ABELSON, MARK BARRY; CHAPIN, MATTHEW JONATHAN; GOMES, PAUL; MINNO, GEORGE; NICE, JACKIE
To: ACIEX THERAPEUTICS, INC.
Reel/Frame 046032/0835 →
CHANGE OF NAME Recorded Jun 8, 2018
From: ACIEX THERAPEUTICS, INC.
To: NICOX OPHTHALMICS, INC.
Reel/Frame 046341/0346 →
Continuity (6)
Continuation 15456249 · Mar 10, 2017
Continuation 14982258 · Dec 29, 2015
Continuation 12724128 · Mar 15, 2010
Provisional Application 61161006 · Mar 17, 2009
Provisional Application 61174850 · May 1, 2009
Related Publication 20180280383A1 · Oct 4, 2018