OCULAR INSERT CONTAINING A GLUCOCORTICOID
In certain embodiments, the invention relates to a sustained release biodegradable intracanalicular insert containing a glucocorticoid dispersed in a hydrogel for the treatment of dry eye disease.
1 . A sustained release biodegradable ocular insert comprising a hydrogel and a glucocorticoid, wherein glucocorticoid particles are dispersed within the hydrogel, and wherein the insert in its dry state has a length of less than about 2.75 mm.
2 . The sustained release biodegradable ocular insert of claim 1 , wherein the insert contains less than about 375 μg dexamethasone or an equivalent dose of another glucocorticoid.
3 . The sustained release biodegradable insert of claim 1 , wherein the insert provides for a release of a therapeutically effective amount of the glucocorticoid for a period of up to about 1 month after administration.
4 . The sustained release biodegradable ocular insert of claim 1 , wherein the glucocorticoid is dexamethasone.
5 . The sustained release biodegradable ocular insert of claim 1 , wherein the insert is an intracanalicular insert.
6 . The sustained release biodegradable ocular insert of claim 1 , comprising from about 160 μg to about 250 μg dexamethasone.
7 . The sustained release biodegradable ocular insert of claim 6 , comprising from about 180 μg to about 220 μg dexamethasone,
8 . The sustained release biodegradable ocular insert of claim 7 , comprising about 200 μg dexamethasone.
9 . The sustained release biodegradable ocular insert of claim 1 , comprising from about 240 μg to about 375 μg dexamethasone.
10 . The sustained release biodegradable ocular insert of claim 9 , comprising from about 270 μg to about 330 μg dexamethasone.
11 . The sustained release biodegradable ocular insert of claim 10 , comprising about 300 μg dexamethasone.
12 . The sustained release biodegradable ocular insert of claim 1 , wherein the insert is cylindrical or essentially cylindrical.
13 . The sustained release biodegradable ocular insert of claim 1 , wherein the insert is non-cylindrical.
14 . The sustained release biodegradable ocular insert of claim 1 , wherein the insert is cylindrical or essentially cylindrical and in its dry state has a length of less than about 2.5 mm.
15 . The sustained release biodegradable ocular insert of claim 1 , wherein the insert is cylindrical or essentially cylindrical and in its dry state has a diameter of less than about 0.75 mm.
16 . The sustained release biodegradable ocular insert of claim 1 , wherein the insert is cylindrical or essentially cylindrical and in its dry state has a length of about 2.14 mm to about 2.36 mm and a diameter of about 0.41 mm to about 0.55 mm.
17 . The sustained release biodegradable ocular insert of claim 1 , wherein the insert is cylindrical or essentially cylindrical and upon hydration (after 24 hours in phosphate-buffered saline at a pH of 7.2 at 37° C.) the diameter of the insert is increased and the length of the insert is decreased.
18 . The sustained release biodegradable ocular insert of claim 17 , wherein the ratio of the diameter of the insert in the hydrated state to the diameter of the insert in the dry state is in the range of about 1.5 to about 4.
19 . The sustained release biodegradable ocular insert of claim 18 , wherein the ratio of the diameter of the insert in the hydrated state to the diameter of the insert in the dry state is in the range of about 2 to about 3.5.
20 . The sustained release biodegradable ocular insert of claim 17 , wherein the ratio of the length of the insert in the hydrated state to the length of the insert in the dry state is about 0.9 or less.
21 - 141 . (canceled)