STEROID-CONTAINING SUSTAINED RELEASE INTRAOCULAR IMPLANTS AND RELATED METHODS

摘要

Biocompatible intraocular implant systems are formulated for discontinuous or intermittent release of therapeutic levels of a therapeutic agent (such as a steroid) to minimize development of side effects associated with continuous or long term use of such agent. The implant system may comprise one or more implant, and preferably, although not necessarily, also contains an auxiliary agent having an activity effective to lessen at least one side effect associated with said therapeutic agent compared to the use of an otherwise identical implant system lacking said auxiliary agent. The implants containing the therapeutic agent and auxiliary agent may be placed in an eye to treat one or more ocular conditions while reducing the ocular side effects otherwise accompanying the use of such therapeutic agent.

主权项

1. A method for treating an ocular condition, the method comprising the steps of:
(a) intravitreal placement of a biodegradable implant which comprises a therapeutic component, which is a steroid; and (b) pulsatile release of the therapeutic component from the implant into the vitreous, thereby treating the ocular condition; wherein the biodegradable implant comprises:
a combination of biodegradable poly(D,L,-lactide-co-glycolide) and poly(D,L,-lactide) polymers in a 1:2 ratio, respectively, and an alpha-2 adrenergic receptor agonist and the steroid in a 60:40 weight ratio of drug to polymer, wherein the alpha-2 adrenergic agonist and steroid are arranged in interleaved alternate layers;wherein the alpha-2 adrenergic receptor agonist is selected from the group consisting of apraclonidine, clonidine, oxymetazoline, epinephrine, norepinephrine, dexmedetomidine, mivazerol, xylazine, medetomidine, and brimonidine; andwherein the steroid is selected from the group consisting of cortisone, prednisolone, fluorometholone, dexamethasone, medrysone, loteprednol, fluazacort, hydrocortisone, betamethasone, prednisone, methylprednisolone, triamcinolone hexacatonide, paramethasone acetate, triamcinolone acetonide, diflorasone, fluocinonide, and mixtures thereof.