# US 2013/0156841 A1 · Method of reducing incidence of intraocular pressure associated with intraocular use of corticosteroids > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0156841 A1 - Document ID: US20130156841A1 - Status: Published application - Kind: A1 - Application number: 13/757,298 - Filed: 2013-02-01 - Published: 2013-06-20 - Earliest claimed: 2009-12-23 - Assignees: Alimera Sciences, Inc. - Inventors: Ken GREEN - Web page: https://patentgrep.com/patent/US20130156841A1 ## CPC - A61K 9/0051: {Ocular inserts or implants} - A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048}) - A61P 3/10: for hyperglycaemia, e.g. antidiabetics - A61P 27/02: Ophthalmic agents - A61P 27/06: Antiglaucoma agents or miotics - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## 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. ## Claims ### 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. ### Claim 2 (depends on 1) The method of claim 1, wherein the ocular disease is diabetic macular edema. ### Claim 3 (depends on 1) The method of claim 1, wherein the incidence of TOP lowering surgery at 1 year after treatment is less than 5%. ### Claim 4 (depends on 1) The method of claim 1, wherein the incidence of TOP lowering surgery at 2 years after treatment is less than 10%. ### Claim 5 (depends on 4) The method of claim 4, wherein the incidence of TOP lowering surgery at 2 years after treatment is less than 5%. ### Claim 6 (depends on 1) The method of claim 1, wherein the incidence of TOP lowering surgery at 3 years after treatment is less than 30%. ### Claim 7 (depends on 6) The method of claim 6, wherein the incidence of TOP lowering surgery at 3 years after treatment is less than 20%. ### Claim 8 (depends on 7) The method of claim 7, wherein the incidence of TOP lowering surgery at 3 years after treatment is less than 10%. ### Claim 9 (depends on 1) 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. ### Claim 10 (depends on 9) 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. ### Claim 11 (depends on 10) 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. ### Claim 12 (depends on 1) 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. ### Claim 13 (depends on 1) 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. ### Claim 14 (depends on 13) 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. ### Claim 15 (depends on 1) The method of claim 1, wherein the corticosteroid is Fluocinolone Acetonide (FA). ### Claim 16 (depends on 1) The method of claim 1, wherein the time period of release is at least eighteen months. ### Claim 17 (depends on 16) The method of claim 16, wherein the time period of release is at least twenty four months. ### Claim 18 (depends on 17) The method of claim 17, wherein the time period of release is at least thirty months. ### Claim 19 (depends on 18) The method of claim 18, wherein the time period of release is at least thirty six months. ### Claim 20 (depends on 1) The method of claim 1, wherein the at least one intravitreal insert settles in the posterior portion of the eye after being inserted. ### Claim 21 (depends on 1) The method of claim 1, wherein the at least one intravitreal insert comprises a polyimide tube, Fluocinolone Acetonide, and a polyvinyl alcohol matrix. ### Claim 22 (depends on 1) The method of claim 1, wherein the at least one insert comprises from 100 to 300 μg of Fluocinolone Acetonide. ### Claim 23 (depends on 22) The method of claim 22, wherein the at least one insert comprises from 180 to 200 μg of Fluocinolone Acetonide. ### Claim 24 (depends on 23) The method of claim 23, wherein the at least one insert comprises 190 μg of Fluocinolone Acetonide. ### Claim 25 (depends on 1) The method of claim 1, wherein the at least one insert is non-bioerodable. ### Claim 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. ### Claim 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.