Ocular therapeutic agent delivery devices and methods for making and using such devices

Abstract

Ocular implant devices (10, 20, 121) for the delivery of a therapeutic agent to an eye (101, 301) in a controlled and sustained manner. Dual mode and single mode drug delivery devices (10, 20, 121) are illustrated and described. Implants (10, 20) suitable for subconjunctival placement are described. Implants (121, 10, 20) suitable for intravitreal placement also are described. The invention also includes fabrication and implementation techniques associated with the unique ocular implant devices (10, 20, 121) that are presented herein.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This patent application is a continuation of copending U.S. patent application Ser. No. 10 / 471,468, filed Sep. 12, 2003 [pending], which is a PCT national phase application of PCT / US0207836 filed Mar. 14, 2002, which is a continuation-in-part of U.S. patent application Ser. No. 09 / 808,149, filed Mar. 15, 2001 [issued Mar. 30, 2004 as U.S. Pat. No. 6,713,081].FIELD OF THE INVENTION [0002] The present invention generally relates to local therapies for the eye and, more particularly, to controlled-release ocular implant devices, including methods for making and using such devices, for delivery of therapeutic agents to the eye. BACKGROUND OF THE INVENTION [0003] In the treatment of many diseases and disorders of the eye, and especially in the case of degenerative or persistent conditions, implantable sustained-release delivery devices have been desired that would continuously administer a therapeutic agent to the eye for a prolonged period ...

AI Technical Summary

Benefits of technology

[0047] The implant subassembly of the intraocular reservoir implants of the invention provide a sustained, substantially constant delivery rate of drug over a prolonged period. The intraocular reservoir implants also can be modified to form dual mode release devices. For instance, in a dual mode configuration, additional therapeutic agent could be dispersed in the silicone fluid before being used to encapsulate the drug core to create an initial higher release rate, or loading dose; alternatively, additional amounts of the drug could be dispersed in or attached as a discrete inlay member onto a separate silicone adhesive used to attach a surface of the reservoir implant subassembly to a suture stub or the like. Alternatively, multi-drug therapy could be provided by including a drug different from the drug core in the silicone surrounding the pellet or, in or on the silicone adhesive used to affix the implant reservoir subassembly, each comprising an encapsulated drug core, can be attached to a common suture stub to provide concurrent delivery of different drugs or additive introduction of a common drug.

[0048] As another dual mode embodiment of the reservoir impla

Problems solved by technology

For instance, oral therapies for the eye fail to provide sustained-release of the drug into the eye.

Instead, oral therapies often only result in negligible actual absorption of the drug in the ocular tissues due to low bioavailability of the drug.

Moreover, adverse side effects have been associated with systemic administration of certain drugs to the eyes.

For instance, systemic treatments of the eye using the immune response modifier cyclosporine A (CsA) have the potential to cause nephrotoxicity or increase the risk of opportunistic infections, among other concerns.

However, therapeutic levels of the drug are not achieved and sustained in the middle or back portions of the eye.

This is a major drawback, as the back (posterior) chamber of the eye is a frequent site of inflammation or otherwise the site of action where, ideally, ocular drug therapy should be targeted for many indications.

Although only about ten percent of people with AMD have the wet form, it poses a much greater threat to vision.

With the wet form of the disease, rapidly growing abnormal blood vessels known as choroidal neovascular membranes (CNVM) develop beneath the macula, leaking fluid and blood that destroy light sensing cells and causing a blinding scar tissue, with resultant sever loss of central vision.

However, in that the macula is located at the back of the eye, treatmen

Images