Method of reducing incidence of intraocular pressure associated with intraocular use of corticosteroids

Abstract

A method of treating an ocular disease in a subject using a corticosteroid with reduced incidence of intraocular pressure lowering surgery comprises injecting an intravitreal insert capable of providing a therapeutic effect for an extended period of time. The intravitreal insert delivers sustained sub-microgram levels of corticosteroid.

We claim: 
     
         1 . A method of treating an ocular disease in a subject using a corticosteroid, wherein the incidence of TOP lowering surgery at 1 year or more after treatment is less than 10%, comprising injecting at least one free-floating intravitreal insert comprising a dosage of corticosteroid into an eye of the subject such that the intravitreal insert settles near the base of the eye, wherein the intravitreal insert is configured to release the corticosteroid in a controlled manner over a time period of at least one year. 
     
     
         2 . The method of  claim 1 , wherein the ocular disease is diabetic macular edema. 
     
     
         3 . The method of  claim 1 , wherein the incidence of TOP lowering surgery at 1 year after treatment is less than 5%. 
     
     
         4 . The method of  claim 1 , wherein the incidence of TOP lowering surgery at 2 years after treatment is less than 10%. 
     
     
         5 . The method of  claim 4 , wherein the incidence of TOP lowering surgery at 2 years after treatment is less than 5%. 
     
     
         6 . The method of  claim 1 , wherein the incidence of TOP lowering surgery at 3 years after treatment is less than 30%. 
     
     
         7 . The method of  claim 6 , wherein the incidence of TOP lowering surgery at 3 years after treatment is less than 20%. 
     
     
         8 . The method of  claim 7 , wherein the incidence of TOP lowering surgery at 3 years after treatment is less than 10%. 
     
     
         9 . The method of  claim 1 , wherein the dosage of the at least one intravitreal insert is at least 0.15 μg/day for at least 24 months. 
     
     
         10 . The method of  claim 9 , wherein the dosage of the at least one intravitreal insert is at least 0.20 μg/day for at least 24 months. 
     
     
         11 . The method of  claim 10 , wherein the dosage of the at least one intravitreal insert is at least 0.25 μg/day for at least 24 months. 
     
     
         12 . The method of  claim 1 , wherein the dosage of the at least one intravitreal insert is from about 0.1 μg/day to about 0.25 μg/day for at least 24 months. 
     
     
         13 . The method of  claim 1 , wherein the dosage of the at least one intravitreal insert is from about 0.2 μg/day to about 0.45 μg/day for at least 24 months. 
     
     
         14 . The method of  claim 13 , wherein the dosage of the at least one intravitreal insert is from about 0.3 μg/day to about 0.45 μg/day for at least 24 months. 
     
     
         15 . The method of  claim 1 , wherein the corticosteroid is Fluocinolone Acetonide (FA). 
     
     
         16 . The method of  claim 1 , wherein the time period of release is at least eighteen months. 
     
     
         17 . The method of  claim 16 , wherein the time period of release is at least twenty four months. 
     
     
         18 . The method of  claim 17 , wherein the time period of release is at least thirty months. 
     
     
         19 . The method of  claim 18 , wherein the time period of release is at least thirty six months. 
     
     
         20 . The method of  claim 1 , wherein the at least one intravitreal insert settles in the posterior portion of the eye after being inserted. 
     
     
         21 . The method of  claim 1 , wherein the at least one intravitreal insert comprises a polyimide tube, Fluocinolone Acetonide, and a polyvinyl alcohol matrix. 
     
     
         22 . The method of  claim 1 , wherein the at least one insert comprises from 100 to 300 μg of Fluocinolone Acetonide. 
     
     
         23 . The method of  claim 22 , wherein the at least one insert comprises from 180 to 200 μg of Fluocinolone Acetonide. 
     
     
         24 . The method of  claim 23 , wherein the at least one insert comprises 190 μg of Fluocinolone Acetonide. 
     
     
         25 . The method of  claim 1 , wherein the at least one insert is non-bioerodable. 
     
     
         26 . A method of administering a corticosteroid to the eye wherein the incidence of TOP lowering surgery at 1 year or more after treatment is less than 10%, comprising injecting at least one free-floating intravitreal insert comprising a corticosteroid into an eye of a subject such that the intravitreal insert settles near the base of the eye, wherein the intravitreal insert is configured to release the corticosteroid in a controlled manner over a time period of at least one year. 
     
     
         27 . A method of reducing the incidence of TOP lowering surgeries in patients receiving intraocular treatment with corticosteroids to less than 10% at 1 year or more after treatment, comprising injecting at least one free-floating intravitreal insert comprising a corticosteroid into an eye of the subject such that the intravitreal insert settles near the base of the eye, wherein the intravitreal insert is configured to release the corticosteroid in a controlled manner over a time period of at least one year.