Method of treating blepharitis
Inventors
Brubaker, Kurt E. • Brazzell, Romulus K. • Haque, Reza M. • Ice, Jr., John C. • BOYER JOSE L., null • Boyer, José L. • Boyd, Joseph B. • Dempsey, Robert J.
Assignees
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Publication Number
US-8349806-B2
Publication Date
2013-01-08
Expiration Date
Abstract
The present invention relates to a method for treating non-infectious, inflammatory chronic posterior blepharitis in a subject. The present invention also relates to a method for treating chronic posterior blepharitis in a subject for over two weeks. The method comprises identifying a subject in need thereof, and topically administering to the eye of the subject a pharmaceutical formulation consisting essentially of an effective amount azithromycin. The present invention further relates to a method for treating dry eye secondary to blepharitis in a subject. The method comprises the steps of: identifying a subject suffering from dry eye secondary to posterior blepharitis, and topically administering to the eye of the subject a pharmaceutical formulation comprising an effective amount of azithromycin. The present invention further relates to method for reducing contact lens intolerance of a subject due to blepharitis or dry eye secondary to blepharitis.
Core Innovation
The invention relates to methods of using a topical ophthalmic formulation consisting essentially of an effective amount of azithromycin to treat non-infectious, inflammatory chronic posterior blepharitis. The method includes identifying a subject suffering from non-infectious, inflammatory chronic posterior blepharitis and topically administering the pharmaceutical formulation to the eye. The formulation is described as an azithromycin ophthalmic solution in a polycarbophil vehicle, including DURASITE®, such as AZASITE®.
The invention also addresses chronic posterior blepharitis for more than two weeks, including treatment for at least two weeks and regimens in which administration continues for more than two weeks, and may be daily then intermittent. It further provides treatment coverage for dry eye secondary to non-infectious, inflammatory blepharitis, including identifying a subject with that condition and topically administering an azithromycin-containing pharmaceutical formulation to the eye.
The invention further addresses contact lens intolerance due to non-infectious, inflammatory blepharitis or dry eye secondary to non-infectious, inflammatory blepharitis by identifying a subject suffering from contact lens intolerance and topically administering an azithromycin-containing pharmaceutical formulation to the eye. The provided content also states that anti-inflammatory and tissue-penetration/sustained concentration rationale is independent of bacterial infection.
Claims Coverage
The independent claims cover five main treatment and use cases. Across these independent claims, the inventive focus is on identifying a subject with a specified non-infectious inflammatory ocular condition and topically administering an azithromycin-containing pharmaceutical formulation consisting essentially of or comprising an effective amount of azithromycin to the eye, including specified time-based regimens and outcome-oriented goals.
Topical azithromycin for non-infectious inflammatory chronic posterior blepharitis
A method for treating non-infectious, inflammatory chronic posterior blepharitis in a subject, comprising identifying a subject suffering from non-infectious, inflammatory chronic posterior blepharitis, and topically administering to the eye of the subject a pharmaceutical formulation consisting essentially of an effective amount of azithromycin.
Topical azithromycin for non-infectious inflammatory chronic posterior blepharitis for more than two weeks
A method for treating non-infectious, inflammatory chronic posterior blepharitis in a subject, comprising identifying a subject suffering from non-infectious, inflammatory chronic posterior blepharitis, and topically administering to the eye of the subject a pharmaceutical formulation consisting essentially of an effective amount of azithromycin for more than two weeks.
Intermittent topical azithromycin regimen over two weeks
A method for treating inflammatory chronic posterior blepharitis in a subject, comprising identifying a subject suffering from non-infectious, inflammatory chronic posterior blepharitis, and topically administering to the eye of the subject a pharmaceutical formulation comprising an effective amount of azithromycin intermittently for over two weeks.
Topical azithromycin for dry eye secondary to non-infectious inflammatory blepharitis
A method for treating dry eye secondary to non-infectious, inflammatory blepharitis in a subject, comprising identifying a subject suffering from dry eye secondary to non-infectious, inflammatory blepharitis, and topically administering to the eye of the subject a pharmaceutical formulation comprising an effective amount of azithromycin.
Reducing contact lens intolerance by increasing comfortable wearing time with topical azithromycin
A method for reducing contact lens intolerance of a subject due to non-infectious, inflammatory blepharitis or dry eye secondary to non-infectious, inflammatory blepharitis, comprising identifying a subject suffering from contact lens intolerance due to non-infectious, inflammatory blepharitis or dry eye secondary to non-infectious, inflammatory blepharitis, and topically administering to the eye of the subject a pharmaceutical formulation comprising an effective amount of azithromycin, whereby the comfortable contact lens wearing time per day in the subject is increased.
Across the independent claims, the core claim coverage is directed to topical azithromycin therapy based on identifying non-infectious, inflammatory posterior blepharitis, including chronic posterior blepharitis for more than two weeks and intermittent administration for over two weeks, as well as treating dry eye secondary to non-infectious, inflammatory blepharitis and reducing contact lens intolerance by increasing comfortable contact lens wearing time.
Stated Advantages
Improved blepharitis sign severity when azithromycin is combined with warm compress over warm compress alone.
Improved meibomian gland dysfunction signs/symptoms after azithromycin (AZASITE®) treatment.
Normalized meibum lipid properties after four weeks, including lipid ordering/trans-rotamers and phase transition temperature.
Improved dry-eye symptoms after four weeks of AZASITE® treatment.
Improved tear-film break-up time (TBUT) after four weeks of AZASITE® treatment.
Increased comfortable contact lens wearing time per day in the subject.
Documented Applications
Treating non-infectious, inflammatory chronic posterior blepharitis.
Treating chronic posterior blepharitis for more than two weeks, including daily or intermittent regimens.
Treating dry eye secondary to non-infectious, inflammatory blepharitis.
Reducing contact lens intolerance due to non-infectious, inflammatory blepharitis or dry eye secondary to non-infectious, inflammatory blepharitis by increasing comfortable contact lens wearing time per day.
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