Sustained release intraocular implants and methods for preventing retinal dysfunction

a technology of intraocular implants and retinal dysfunction, which is applied in the field of sustained release intraocular implants and methods for preventing retinal dysfunction, can solve the problems that the technique of administering brimonidine to the posterior chamber of the eye is not sufficient to address this issue, and achieves the effect of few or no negative side effects

Inactive Publication Date: 2005-11-03
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007] It would be advantageous to provide eye implantable drug delivery systems, such as intraocular implants, and methods of using such systems, that are

Problems solved by technology

Currently available techniques for administering brimonidine to the p

Method used

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  • Sustained release intraocular implants and methods for preventing retinal dysfunction
  • Sustained release intraocular implants and methods for preventing retinal dysfunction
  • Sustained release intraocular implants and methods for preventing retinal dysfunction

Examples

Experimental program
Comparison scheme
Effect test

example 2

In Vivo Testing of Intraocular Implants Containing Brimonidine and a Biodegradable Polymer Matrix

[0157] Implants containing brimonidine tartrate, such as formulation #17 described in Example 1, and placebo implants without a therapeutic agent were placed in the vitreous of normal eyes of Dutch Belt pigmented rabbits (2.0-2.5 kg). Two weeks after implantation, electroretinograms (ERGs) were measured in each of the eyes of the rabbits as follows. As understood by persons of ordinary skill in the art understand, the ERG reflects the summation of electrical responses generated by neurons and non-neuronal cells in the retina and pigment epithelium in response to light. The major ERG components are the fast negative A-wave, the fast positive B-wave and the slow, positive C-wave. The leading edge of the A-wave provides a direct measure of photoreceptor activity, while the B-wave provides a reflection of the action of glial and other cells.

[0158] The rabbits were dark adapted for more tha...

example 3

Treatment of Ocular Conditions with Various Active Agents

[0167] An implant can be formulated with various active agents, including the agents described herein, following the procedures in the Examples above. These implants can provide an extended therapeutic treatment of an ocular condition, that is a therapeutic effect during a period of time during release of the active agent or after release of all of the active agent from the implant and during which there is no longer a therapeutic amount of the active agent present at the ocular site at which the implant was placed. Thus, an implant can be prepared containing an alpha-2 adrenergic receptor agonist, such as clonidine, apraclonidine, or brimonidine (available from Allergan, Irvine, Calif. as brimonidine tartrate ophthalmic solution, under the tradename Alphagan-P®). Thus, for example, a brimonidine extended therapeutic treatment implant can be implanted into an ocular site (i.e. into the vitreous) of a patient with an ocular co...

example 4

In Vivo Testing of Intraocular Microspheres Containing Brimonidine and a Biodegradable Polymer Matrix

[0168] I. Introduction

[0169] An experiment was carried out with microspheres containing an alpha 2 agonist as the active agent. The alpha-2 agonist used was brimonidine free base. The brimonidine microspheres were injected (or synonymously implanted) into various vitreal locations of one normal eye of four separate rabbits. Thus, four mammalian eyes were injected with the brimonidine microspheres. The vitreous of each other eye of the same four rabbits was injected with Kenalog® 40. Kenalog® 40 is a triamcinolone suspension. Each milliliter of Kenalog® 40 includes 40 milligrams of triamcinolone acetonide, sodium chloride as a tonicity agent, 10 mg of benzyl alcohol as a preservative, and 7.5 mg of carboxymethylcellulose and 0.4 mg of polysorbate 80 as resuspension aids.

[0170] This experiment determined that intravitreal alpha-2 agonist microspheres, such as brimonidine microsphere...

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Abstract

Biocompatible intraocular microspheres and implants include an alpha-2 adrenergic receptor agonist and a polymer associated with the alpha-2 adrenergic receptor agonist to facilitate release of the alpha-2 adrenergic receptor agonist into an eye for an extended period of time. The alpha-2 adrenergic receptor agonist may be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. The implants may be placed in an eye to treat or to prevent the occurrence of one or more ocular conditions, to reduce one or more symptoms of an ocular condition, such as an ocular neurosensory disorder and the like, to enhance normal retinal function and/or to lower intraocular pressure.

Description

CROSS REFERENCE [0001] This application is a continuation in part of application Ser. No. 10 / 837,143 filed Apr. 30, 2004, the entire content of which is incorporated herein by reference.BACKGROUND [0002] The present invention generally relates to devices and methods to treat an eye of a patient, and more specifically to intraocular implants that provide extended release of a therapeutic agent to an eye in which the implant is placed, and to methods of making and using such implants, for example, to enhance retinal function and / or to prevent retinal dysfunction. [0003] Brimonidine, 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline, is an alpha-2-selective adrenergic receptor agonist that is effective in the treatment of open-angle glaucoma by decreasing aqueous humor production and increasing uveoscleral outflow. Brimonidine is available in two chemical forms, brimonidine tartrate and brimonidine free base. Brimonidine tartrate (Alphagan P®) is available from Allergan, Inc., for tre...

Claims

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Application Information

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IPC IPC(8): A61F2/02A61K9/00A61K9/14A61K31/498
CPCA61K31/498A61K9/0051A61P27/02A61P27/16A61K47/34
Inventor BURKE, JAMESHUGHES, PATRICK M.ORILLA, WERHNER C.LIN, TONESCOBAR, MARIAHUANG, GLENNZHANG, KAI-MINGWHEELER, LARRY A.DONN, ROSY S.
Owner ALLERGAN INC
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