Extended therapeutic effect ocular implant treatments

Abstract

Methods for treating ocular conditions by inserting an implant comprising an active agent into an ocular site of a patient thereby obtaining an amelioration of a symptom of the ocular condition (i.e. a therapeutic effect) for an extended period of time during which a therapeutic amount or a detectable amount of the active agent is not present at the ocular site.

1 . A method for treating an ocular condition, the method comprising the steps of: 
 (a) inserting an implant into an ocular site of a patient with an ocular condition, the implant comprising (i) an active agent, and (ii) a carrier associated with the active agent;    (b) releasing substantially all of the active agent from the implant, and;    (c) obtaining an improvement in the ocular condition at a time when a therapeutic amount of the active agent is not present at the ocular site.    
     
     
         2 . The method of  claim 1 , further comprising the step of maintaining the improvement in the ocular condition for an extended period of time during which a therapeutic amount of the active agent is not present at the ocular site.  
     
     
         3 . The method of  claim 2 , wherein the releasing step occurs over a first period of time X, and the subsequent extended period of time during which an improvement in the ocular condition is maintained, although a therapeutic amount of the active agent is not present at the ocular site, is a second period of time between 0.5× and 100×.  
     
     
         4 . The method of  claim 1 , wherein the active agent is an anti-inflammatory agent.  
     
     
         5 . The method of  claim 1 , wherein the carrier is a bioerodible polymer.  
     
     
         6 . The method of 1, wherein the implant has a weight between about 1 μg and about 100 mg.  
     
     
         7 . The method of  claim 1 , wherein the implant has no dimension less than about 0.1 mm and no dimension greater than about 20 mm.  
     
     
         8 . The method of  claim 1  wherein the improvement of the ocular condition is determined by observing an improved visual acuity.  
     
     
         9 . The method of  claim 1  wherein the improvement of the ocular condition is determined by observing an improved visual contrast sensitivity.  
     
     
         10 . The method of  claim 1  wherein the improvement of the ocular condition is determined by observing a decreased retinal or choroidal blood vessel leakage.  
     
     
         11 . The method of  claim 1  wherein the improvement of the ocular condition is determined by observing a decreased retinal or macular thickness.  
     
     
         12 . The method of  claim 1 , wherein the improvement in the ocular condition occurs at a time when a detectable amount of the active agent is not present at the ocular site.  
     
     
         13 . The method of  claim 1 , wherein the ocular site is the vitreous.  
     
     
         14 . The method of  claim 1 , wherein the active agent is dexamethasone.  
     
     
         15 . The method of  claim 3 , wherein the first period of time is between about 30 days and about 40 days.  
     
     
         16 . The method of  claim 3 , wherein the first period of time is about 35 days.  
     
     
         17 . The method of  claim 15 , wherein the second period of time is between about 30 days and about 180 days.  
     
     
         18 . A method for treating a chronic ocular condition, the method comprising the steps of: 
 (a) inserting an implant into an ocular site of a patient with an ocular condition, the implant comprising (i) an active agent, and (ii) a carrier associated with the active agent;    (b) releasing substantially all of the active agent from the implant;    (c) obtaining an improvement in the ocular condition at a time when a therapeutic amount of the active agent is not present at the ocular site, and;    (d) maintaining the improvement in the ocular condition for an extended period of time during which a therapeutic amount of the active agent is not present at the ocular site.    
     
     
         19 . A method for treating an inflammatory posterior ocular condition, the method comprising the steps of: 
 (a) inserting a biodegradable implant into a posterior ocular site of a patient with an inflammatory posterior ocular condition, the biodegradable implant comprising (i) an anti-inflammatory active agent mixed with (ii) a biodegradable polymer;    (b) releasing substantially all of the anti-inflammatory active agent from the biodegradable implant;    (c) obtaining an improvement in the inflammatory posterior ocular condition at a time when a therapeutic amount of the anti-inflammatory active agent is not present at the posterior ocular site, and;    (d) maintaining the improvement in the inflammatory ocular condition for an extended period of time during which a therapeutic amount of the anti-inflammatory active agent is not present at the posterior ocular site.    
     
     
         20 . The method of  claim 19 , wherein the inserting step comprises the step of placing the biodegradable implant into the vitreous through the pars plana and placing the implant adjacent thereto in the vitreous cavity.  
     
     
         21 . A method for treating persistent macular edema, the method comprising the steps of: 
 (a) inserting a biodegradable implant deep into the vitreous of a patient with persistent macular edema, the biodegradable implant comprising (i) dexamethasone mixed with (ii) a bioerodible PLGA co-polymer;    (b) releasing all of the dexamethasone from the biodegradable implant;    (c) obtaining an improvement in the persistent macular edema at a time when a therapeutic amount of the dexamethasone is not present in the vitreous, and;    (d) maintaining the improvement in the persistent macular edema for an extended period of time during which a therapeutic amount of the dexamethasone is not present in the vitreous.    
     
     
         22 . The method of  claim 21 , wherein the inserting step comprises the step of placing the biodegradable implant into the vitreous about 2 mm to about 6 mm anterior of the macular  
     
     
         23 . The method of  claim 21 , wherein the releasing step comprises the step of releasing about 700 μg of dexamethasone from the biodegradable implant.  
     
     
         24 . The method of  claim 23 , wherein the releasing step comprises the step of releasing about 700 μg of dexamethasone from the biodegradable implant within about 30 days to 40 days after the inserting step.  
     
     
         24 . The method of  claim 21 , wherein the obtaining step comprises obtaining an improvement in the visual acuity of the patient.  
     
     
         25 . The method of  claim 24 , wherein the improvement in the visual acuity of the patient is obtained within about 30 days to about 180 days after the inserting step.  
     
     
         26 . The method of  claim 25 , wherein the maintaining step, by which the improvement in the visual acuity of the patient with persistent macular edema is maintained for an extended period of time during which a therapeutic amount of the dexamethasone is not present in the vitreous, is a period of time of about 30 days to about 150 days after the obtaining step.  
     
     
         27 . A method for improving the visual acuity of a patient with persistent macular edema, the method comprising the steps of: 
 (a) inserting a biodegradable implant into the vitreous of a patient with persistent macular edema by placing the biodegradable implant about 2 mm to about 6 mm anterior of the macular, the biodegradable implant comprising (i) about 700 μg dexamethasone mixed with (ii) a bioerodible PLGA co-polymer;    (b) releasing the 700 μg of dexamethasone from the biodegradable implant within about 30 days to about 40 days after the inserting step;    (c) obtaining an improvement in the visual acuity of the patient with the persistent macular edema at a time within about 30 days and 180 days after the inserting step during which time a therapeutic amount of the dexamethasone is not present in the vitreous, and;    (d) maintaining the improvement in the visual acuity of the patient with the persistent macular edema for about 30 days to about 150 days after the obtaining step during a time a therapeutic amount of the dexamethasone is not present in the vitreous.    
     
     
         28 . A method for treating an ocular condition, the method comprising the steps of: 
 (a) inserting an implant into the vitreous cavity of a patient with an ocular condition, the implant comprising (i) a steroid, and (ii) a carrier associated with the steroid;    (b) releasing substantially all of the steroid from the implant, and;    (c) obtaining an improvement in the ocular condition with no increase in intraocular pressure above about 25 mm Hg.    
     
     
         29 . A method for treating an ocular condition, the method comprising the steps of: 
 (a) inserting an implant into the vitreous cavity of a patient with an ocular condition, the implant comprising (i) a steroid, and (ii) a carrier associated with the steroid;    (b) releasing substantially all of the steroid from the implant, and;    (c) obtaining an improvement in the ocular condition with no occurrence of an ocular cataract in the patient.