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 - 25 . (canceled)
26 . A method for treating dry eye disease (DED) comprising: inserting an ocular insert into an eye of the subject, wherein the ocular insert releases azithromycin into the eye at a sub-antibiotic dose to reduce a symptom of the DED.
27 . The method of claim 26 , wherein the ocular insert is inserted into a fornix of the eye.
28 . The method of claim 26 , wherein the ocular insert is inserted into a cul-de-sac of the eye.
29 . The method of claim 26 , wherein the ocular insert comprises a formulation comprising azithromycin and a pharmaceutically acceptable carrier.
30 . The method of claim 29 , wherein the carrier comprises a solid filler.
31 . The method of claim 29 , wherein the carrier comprises a disintegration agent.
32 . The method of claim 29 , wherein the carrier is selected to obtain a release profile of the sub-antibiotic dose of azithromycin over at least 6 months.
33 . The method of claim 29 , wherein the formulation comprises a high molecular weight, anionic mucomimetic polymer, a gelling polysaccharide, a finely-divided drug carrier substrate, or a combination thereof.
34 . The method of claim 26 , wherein the DED is aqueous tear-deficient dry eye (ADDE) or evaporative dry eye (EDE).
35 . The method of claim 26 , wherein the dry eye disease is ADDE and EDE, and the ADDE and EDE are treated simultaneously.
36 . The method of claim 26 , 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, damage to corneal or conjunctival epithelium and tissues, or combinations thereof.
37 . The method of claim 26 , wherein the sub-antibiotic dose of azithromycin from the ocular insert increases tear break up time, increases a meibomian gland secretion score, decreases a corneal staining, decreases conjunctival staining, or combinations thereof.
38 . The method of claim 26 , wherein the sub-antibiotic dose of azithromycin from the ocular insert reduces a symptom of blepharitis.
39 . The method of claim 26 , wherein the sub-antibiotic dose of azithromycin from the ocular insert improves the amount or quality of meibum produced.
40 . The method of claim 26 , wherein the DED does not result from bacterial infection, parasitic infection, or inflammation of tissue.
41 . The method claim 26 , wherein the ocular insert maintains the release of azithromycin into the eye at the sub-antibiotic dose for a duration of between at least one month and at least one year.
42 . An ocular insert comprising a formulation comprising azithromycin and a pharmaceutically acceptable carrier, wherein the ocular insert is configured to provide sustained release of azithromycin to an eye at a sub-antibiotic dose to reduce a symptom of dry eye disease (DED).
43 . The ocular insert of claim 42 , wherein the carrier comprises a solid filler or a disintegration agent.
44 . The ocular insert of claim 42 , wherein the ocular insert is configured to be inserted into a fornix of the eye.
45 . The ocular insert of claim 42 , wherein the formulation comprises a high molecular weight, anionic mucomimetic polymer, a gelling polysaccharide, a finely-divided drug carrier substrate, or a combination thereof.