Drug Delivery System and Methods of Treating Open Angle Glaucoma and Ocular Hypertension

Abstract

A method of decreasing intraocular pressure (IOP) in an eye of a patient in need thereof includes implanting a first lacrimal implant through an upper punctum and into an upper lacrimal canaliculus of the eye of the patient. The method may further comprise implanting a second lacrimal implant through a lower punctum and into a lower lacrimal canaliculus of the eye of the patient, and releasing, on a sustained basis a therapeutically effective amount of an intraocular pressure-reducing therapeutic agent.

1 . A kit for treating a patient with Open Angle Glaucoma (OAG) or Ocular Hypertension (OH) in an eye, comprising:
 a unit dosage format per eye of a prostaglandin analog comprising a first lacrimal implant and a second lacrimal implant, wherein the first lacrimal implant comprises a sustained release formulation of a prostaglandin analog configured for release in a therapeutically effective dose from the first lacrimal implant over a treatment period; and, wherein the second lacrimal implant is a blank lacrimal implant that does not comprise a prostaglandin analog.   
     
     
         2 . The kit of  claim 1 , wherein the first or second lacrimal implant is a punctual plug. 
     
     
         3 . The kit of  claim 1 , wherein the first or second lacrimal implant comprises a first member defining a first axis and having a first end along the first axis; a second member defining a second axis and having a second end along the second axis; and a third member connecting the first end of the first member and the second end of the second member at a first angle to form an angled intersection. 
     
     
         4 . The kit of  claim 3 , wherein in the second member of the first or second lacrimal implant further comprises a cavity for insertion of a drug core comprising the prostaglandin analog. 
     
     
         5 . The kit of  claim 3 , wherein the third member of the first or second lacrimal implant further comprises a bore that is characterized by a third axis and a second angle, wherein the first angle is defined by the first axis with respect to the second axis, the second angle is defined by the first axis with respective to the third axis, and the bore is configured to be accessible to an insertion tool for facilitating insertion of the implant. 
     
     
         6 . The kit of  claim 3 , wherein the lacrimal implant further comprises the prostaglandin analog dispersed throughout the implant. 
     
     
         7 . The kit of  claim 1 , wherein the first or second lacrimal implant is configured with a retention rate of about 90% or greater at week 12 in a lower punctum. 
     
     
         8 . The kit of  claim 1 , wherein the first or second lacrimal implant is configured with a retention rate of about 85% or greater at week 8 in the upper punctum. 
     
     
         9 . The kit of  claim 1 , wherein the first or second lacrimal implant is made of a material that comprises a plastic, a rubber, a polymer, a composite or a material that comprises a liquid silicone rubber, or a mixture including a liquid silicone rubber. 
     
     
         10 . The kit of  claim 9 , wherein the first or second lacrimal implant further comprises a green colorant. 
     
     
         11 . The kit of  claim 1 , wherein the first or second lacrimal implant comprises a first member, a second member and a heel that is at least partially fabricated with silicone 
     
     
         12 . (canceled) 
     
     
         13 . (canceled) 
     
     
         14 . The kit of  claim 1 , wherein the first lacrimal implant is configured for insertion into an upper punctum of the eye. 
     
     
         15 . The kit of  claim 1 , wherein the second lacrimal implant is configured for insertion into a lower punctum of the eye. 
     
     
         16 - 24 . (canceled) 
     
     
         25 . The kit of  claim 1 , wherein the sustained release formulation is configured to provide a dosage of the prostaglandin analog sufficient to reduce the intraocular pressure of the eye by at least 5 mm Hg from baseline for a continuous period of time selected from at least 12 weeks after implantation of the first lacrimal implant and second lacrimal implant. 
     
     
         26 . The kit of  claim 1 , wherein the treatment period is at least 4 weeks. 
     
     
         27 . The kit of  claim 1 , wherein the treatment period is at least 8 weeks. 
     
     
         28 . The kit of  claim 1 , wherein the treatment period is at least 12 weeks. 
     
     
         29 . The kit of  claim 1 , further comprising an insertion tool. 
     
     
         30 . The kit of  claim 1 , wherein the patient has a baseline TOP between about 22 mm Hg and about 33 mm Hg. 
     
     
         31 . The kit of  claim 1 , wherein the first or second lacrimal implant comprises a first member defining a first axis and having a first end along the first axis; a second member defining a second axis and having a second end along the second axis; and a third member connecting the first end of the first member and the second end of the second member at a first angle to form an angled intersection and wherein the third member of the lacrimal implant further comprises a bore defining a third axis and a second angle having an upper surface, wherein the first angle is defined by the first axis with respect to the second axis, the second angle is defined by the first axis with respect to the third axis, and the bore is configured to be accessible to an insertion tool for facilitating insertion of the implant and extended from the upper surface into the third member.