DRUG ELUTING OCULAR IMPLANT WITH INTERNAL PLUG
Disclosed herein are drug delivery devices and methods for the treatment of ocular disorders requiring targeted and controlled administration of a drug to an interior portion of the eye for reduction or prevention of symptoms of the disorder. The devices are capable of controlled release of one or more drugs and may also include structures which allows for treatment of increased intraocular pressure by permitting aqueous humor to flow out of the anterior chamber of the eye through the device.
1 . A drug delivery ocular implant comprising:
an optionally biodegradable elongate outer shell having a first and second end portions, the outer shell being shaped to define an interior lumen;
at least a first drug positioned within the interior lumen;
one or more orifices positioned in the first end portion of the outer shell;
an internal plug comprising a hydrogel located in the interior lumen in the first end portion of the outer shell and located between the first drug and the one or more orifices;
wherein the internal plug is permeable to the first drug, thereby allowing passage of the drug through the internal plug, through the orifices and out of the implant.
2 . The implant of claim 1 , wherein the first end portion is the distal portion of the implant and includes the distal ⅔ of the implant.
3 . The implant of claim 1 , wherein the first drug is an anti-vascular endothelial growth factor (anti-VEGF) drug.
4 . The implant of claim 3 , wherein the anti-VEGF drug is selected from ranibizumab (LUCENTIS®), bevacizumab (AVASTIN®), pegaptanib (MACUGEN®), sunitinib, and sorafenib.
5 . The implant of claim 4 , wherein the drug is combined with a poly-hydroxy or carbohydrate excipient.
6 . The implant of claim 5 wherein the poly-hydroxy or carbohydrate excipient is selected from ethylcellulose, methylcellulose, hydroxymethylcellulose, dextrans, dextrose, fructose, glycerin, monoglycerides, diglycerides, lactose, maltodextrins, and starch.
7 . The implant of claim 1 , wherein the first drug is a steroid.
8 . The implant of claim 1 , wherein the implant further comprises a shunt portion comprising one or more outflow apertures and an inflow at or near a proximal end of the implant.
9 . The implant of claim 8 , wherein the implant further comprises an optionally biodegradable partition located within the interior lumen between the drug and the shunt portion.
10 . The implant of claim 1 , wherein the internal plug is closely fit to an inner wall of the interior lumen.
11 . The implant of claim 1 , wherein the implant fits within a hollow needle having a diameter of 21 to 27 gauge.
12 . The implant of claim 1 , wherein at least one orifice is covered by an optionally biodegradable membrane.