In December 2004, Bausch & Lomb received FDA approval to manufacture and distribute Zylet, a new ophthalmic suspension that combines loteprednol etabonate 0.5%, the first and only ester-based corticosteroid, and tobramycin 0.3%, a timetested aminoglycoside antibiotic.
Zylet is approved for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of a bacterial ocular infection exists.
Loteprednol is designed to be active at the site of application and deactivated in a predictable single reaction after achieving its therapeutic effect, thus minimizing ocular hypertension without sacrificing powerful steroid action. Unlike other steroids (prednisolone, dexamethasone, fluorometholone, rimexolone and medrysone), the number 20 position ketone group is absent. This group has been implicated in increasing the risk of cataract formation and elevated IOP with long-term use.
In contrast, loteprednol's high lipid solubility helps active ingredients penetrate the cornea, where they exert their anti-inflammatory effect before naturally occurring esterases convert loteprednol into an inactive metabolite. When added to tobramycin, an effective antibiotic, loteprednol is a well-tolerated agent for treating a wide spectrum of chronic inflammatory ocular conditions.
Copyright Boucher Communications, Inc. Mar 2005
Provided by ProQuest Information and Learning Company. All rights Reserved
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