FORMULATIONS AND METHODS FOR TREATING CONDITIONS OF THE EYE
The present disclosure relates to methods of treating chronic conditions of the eye, such as dry eye disease and blepharitis, as well as to methods for increasing secretion of meibum. This disclosure also relates to formulations suitable for treating chronic conditions of the eye such as dry eye disease and blepharitis.
1 - 82 . (canceled)
83 . A method of treating dry eye disease comprising administering to an external surface of an eyelid of a subject a pharmaceutical formulation comprising azelaic acid, wherein the administration of said pharmaceutical formulation reduces a symptom of dry eye disease.
84 . The method of claim 83 , wherein the dry eye disease is tear deficient dry eye.
85 . The method of claim 83 , wherein the dry eye disease is evaporative dry eye.
86 . The method of claim 83 , wherein the symptom of dry eye disease is meibomian gland dysfunction, redness, stinging, burning, itching, light sensitivity, watery eyes, blurry vision, irregularities of the ocular surface, or damage to corneal or conjunctival epithelium and tissues.
87 - 88 . (canceled)
89 . The method of claim 83 , wherein the pharmaceutical formulation is administered daily.
90 . (canceled)
91 . The method of claim 83 , wherein the pharmaceutical formulation is administered daily for at least 6 months.
92 . The method of claim 83 , wherein the pharmaceutical formulation is administered daily for at least 1 year.
93 . The method of claim 83 , wherein the pharmaceutical formulation is administered as a cream, gel, suspension, solution, ointment, or spray.
94 - 95 . (canceled)
96 . The method of claim 83 , wherein a concentration of azelaic acid in the pharmaceutical formulation is between about 1% and about 20%.
97 . (canceled)
98 . The method of claim 83 , wherein the pharmaceutical formulation further comprises azithromycin.
99 . The method of claim 98 , wherein a concentration of azithromycin in the pharmaceutical formulation is between about 0.1% and 0.5%.
100 - 103 . (canceled)
104 . A method of treating blepharitis comprising administering to an external surface of an eyelid of a subject a pharmaceutical formulation comprising azelaic acid, wherein the administration of said pharmaceutical formulation reduces a symptom of blepharitis.
105 . The method of claim 104 , wherein the blepharitis is anterior blepharitis.
106 . The method of claim 104 , wherein the blepharitis is posterior blepharitis.
107 . The method of claim 104 , wherein the symptom of blepharitis is irritation, reddening, itching, burning, edema, or crusting.
108 - 109 . (canceled)
110 . The method of claim 104 , wherein the pharmaceutical formulation is administered daily.
111 . (canceled)
112 . The method of claim 110 , wherein the pharmaceutical formulation is administered daily for at least 6 months.
113 . The method of claim 110 , wherein the pharmaceutical formulation is administered daily for at least 1 year.
114 . The method of claim 104 , wherein the pharmaceutical formulation is administered as a cream, gel, suspension, solution, ointment, or spray.
115 - 116 . (canceled)
117 . The method of claim 104 , wherein a concentration of azelaic acid in the pharmaceutical formulation is between about 1% and about 20%.
118 . (canceled)
119 . The method of claim 104 , wherein the pharmaceutical formulation further comprises azithromycin.
120 . The method of claim 119 , wherein a concentration of azithromycin in the pharmaceutical formulation is between about 0.1% and 0.5%.
121 - 123 . (canceled)
124 . A method for increasing secretion of meibum comprising administering to an external surface of an eyelid of a subject a pharmaceutical formulation comprising azelaic acid, wherein the administration of said pharmaceutical formulation reduces a symptom of inadequate tear production or poor quality of tears.
125 . The method of claim 124 , wherein meibum fluidity is increased.
126 . The method of claim 124 , wherein meibum melting temperature is lowered.
127 - 161 . (canceled)
162 . The method of any one of claim 183 , wherein the pharmaceutical formulation further comprises at least one polyol.
163 - 164 . (canceled)
165 . The method of claim 162 , wherein the at least one polyol is selected from propylene glycol, polyethylene glycol, glycerol, erythritol, mannitol, or sorbitol.
166 . The method of claim 165 , wherein the at least one polyol is propylene glycol.
167 - 171 . (canceled)
172 . The method of claim 83 , wherein the administration of the pharmaceutical formulation results in an increase in tear breakup time, an increase in meibomian gland secretion score, an increase in meibum quality, a decrease in corneal staining, or a decrease in conjunctival staining.
173 . The method of claim 104 , wherein the administration of the pharmaceutical formulation results in an increase in tear breakup time, an increase in meibomian gland secretion score, an increase in meibum quality, a decrease in corneal staining, a decrease in conjunctival staining, a decrease in the number of keratinized meibomian glands, a decrease in redness, a decrease in swelling, or a decrease in demodex mite counts.
174 . The method of claim 104 , wherein the administration of the pharmaceutical formulation results in an increase in tear breakup time, an increase in meibomian gland secretion score, an increase in meibum quality, a decrease in corneal staining, a decrease in conjunctival staining, a decrease in the number of keratinized meibomian glands, a decrease in redness, a decrease in swelling, or a decrease in demodex mite counts.
175 . The method of claim 83 , wherein the subject has meibomian gland dysfunction.
176 . The method of claim 104 , wherein the pharmaceutical formulation further comprises at least one polyol.
177 . The method of claim 124 , wherein the pharmaceutical formulation further comprises at least one polyol.