DRUG DELIVERY DEVICES FOR DELIVERY OF OCULAR THERAPEUTIC AGENTS
Drug delivery devices comprising a non-bioabsorbable polymer structure configured to support a composition comprising an active agent. The devices include a plurality of portions fused together and a recess configured to support the composition. At least one of the portions includes an impermeable polymer and at least one other portion includes a rate-limiting water-permeable polymer. The rate-limiting water-permeable polymer allows for transportation of the active agent to an exterior of the device.
1 . A device for insertion in the eye, the device comprising:
a first portion including a recess configured to support a composition comprising an active agent, the first portion comprising an impermeable polymer; and
a second portion fused to the first portion, the second portion comprising a rate-limiting water-permeable polymer that allows for transportation of the active agent to an exterior of the device, wherein the rate-limiting water-permeable polymer includes a thickness in a range of about 20 μm to about 500 μm.
2 . The device set forth in claim 1 further comprising
a flange fused to the second portion.
3 . The device set forth in claim 1 wherein
the second portion includes a base and a flange integral with the base.
4 . A device for insertion in the eye, the device comprising:
a first portion comprising a rate-limiting water-permeable polymer;
a second portion fused to the first portion, the second portion including a recess configured to support a composition comprising an active agent, the second portion comprising a rate-limiting water-permeable polymer; and
a third portion fused to the second portion, the third portion comprising a rate-limiting water-permeable polymer,
wherein the rate-limiting water-permeable polymer includes a thickness in a range of about 20 μm to about 500 μm and allows for transportation of the active agent to an exterior of the device.
5 . A device for insertion in the eye, the device comprising:
a non-bioabsorbable polymer structure comprising a rate-limiting water-permeable polymer; and
a composition supported within an enclosure of the non-bioabsorbable polymer structure, the composition including an active agent;
wherein the non-bioabsorbable polymer structure includes a thickness in a range of about 200 μm to about 800 μm, and wherein the thickness is configured to control an elution rate of the active agent through the rate-limiting water-permeable polymer, wherein the rate-limiting water-permeable polymer is a copolymer having both hydrophobic and hydrophilic monomers.
6 . The device set forth in claim 5 , wherein the rate-limiting water-permeable polymer is selected from the group consisting of: ethylene vinyl acetate with a vinyl acetate content of about 10% to about 50% by weight (EVA-10-50) and ethylene vinyl alcohol with a vinyl alcohol content of about 40% to about 80% by weight (EVOH-40-80).
7 . (canceled)
8 . The device set forth in claim 5 , wherein the active agent is selected from the group consisting of: 3-hydroxy-2,2-bis(hydroxymethyl)propyl 7-((1R,2R,3R,5S)-2-((R)-3-(benzo[b]thiophen-2-yl)-3-hydroxypropyl)-3,5-dihydroxycyclopentyl)heptanoate (AR-102), 7-((1R,2R,3R,5S)-2-((R)-3-(benzo[b]thiophen-2-yl)-3-hydroxypropyl)-3,5-dihydroxycyclopentyl)heptanoic acid (AR-102 free acid), dorzolamide, ethacrynic acid, latanoprost, latanoprost free acid, travoprost, travoprost free acid, bimatoprost, bimatoprost free acid, tafluprost, tafluprost free acid, dexamethasone, brimonidine, timolol, or salts thereof.
9 . A method of treating an ocular condition comprising inserting the device of any one of claims 5 , 6 , and 8 to the conjunctiva of the eye.
10 . The method of claim 9 wherein the device is inserted into the upper or lower formix of the eye.
11 . A method of treating an ocular condition comprising implanting episclerally or supraconjunctivally a drug delivery device comprising an active agent, wherein the active agent is released at a rate of about 0.0001 to about 200 micrograms/hr.
12 . The method of claim 11 , wherein the active agent is released at a rate of about 0.0001 to about 30 micrograms/hr.
13 . The method of claim 11 , wherein the active agent is released at a rate of about 0.001 micrograms/hr to about 30 micrograms/hr.
14 . The method of claim 11 , wherein the active agent is released at a rate of about 0.001 micrograms/hr to about 10 micrograms/hr.
15 . The method of claim 11 , wherein the active agent comprises a prostaglandin active agent, the active agent being implanted episclerally and being released at a rate of about 0.00025 to about 0.0075 micrograms/hr.
16 . The method of claim 15 , wherein the active agent comprises latanoprost, travoprost, bimatoprost, each of their free acids or salts.
17 . The method of claim 11 , wherein the active agent comprises a prostaglandin active agent, the active agent being implanted supraconjunctivally and being released at a rate of about 0.0005 to about 0.015 micrograms/hr.
18 . The method of claim 17 , wherein the active agent comprises latanoprost, travoprost, bimatoprost, each of their free acids or salts.
19 . The method of claim 11 , wherein the active agent comprises a rho-kinase active agent, the active agent being implanted episclerally, and being released at a rate of about 0.02 to about 0.6 micrograms/hr.
20 . The method of claim 19 , wherein the active agent comprises a Y-39983 salt.
21 . The method of claim 11 , wherein the active agent comprises a rho-kinase active agent, the active agent being implanted supraconjunctivally and being released at a rate of about 0.04 to about 1.2 micrograms/hr.
22 . The method of claim 21 , wherein the active agent comprises a Y-39983 salt.
23 . The method of claim 11 , wherein the active agent is a non-prostaglandin and non-rho-kinase active agent, the active agent being implanted episclerally and being released at a rate of about 0.25 to about 7.5 micrograms/hr.
24 . The method of claim 23 , wherein the active agent comprises timolol or a salt thereof.
25 . The method of claim 11 , wherein the active agent is a non-prostaglandin and non-rho-kinase active agent, the active agent being implanted supraconjunctivally and being released at a rate of about 0.5 to about 15 micrograms/hr.
26 . The method of claim 25 , wherein the active agent comprises timolol or a salt thereof.
27 . The device set forth in claim 1 , wherein the device is substantially cylindrical-shaped.
28 . The device set forth in claim 4 , wherein the device is substantially cylindrical-shaped.
29 . The device set forth in claim 5 , wherein the device is substantially cylindrical-shaped.