Drug safety evaluation of intravitreal triamcinolone acetonide.

INTRODUCTION: Triamcinolone acetonide (TA) is a steroidal drug that has been widely administered intravitreally for retinal and choroidal conditions. Safety of steroidal products for intraocular use is essential because of their risk of ocular adverse events. This review comprehensively discusses the safety of intravitreal administration of TA. AREAS COVERED: This paper analyzes the mechanisms of action and key pharmacokinetic attributes and provides a discussion of the main clinical trials investigating clinical applications of intravitreal TA. The safety of intravitreal TA is evaluated through a search of the Medline database from 1980 to 2011. The most relevant literature on the safety of intravitreal TA is also discussed. EXPERT OPINION: The complications of intravitreal TA therapy include secondary ocular hypertension in about 20 - 40% of eyes, steroid-induced cataract in about 15 - 20% of cases and postinjection infectious endophthalmitis and pseudoendophthalmitis in less than 1%. TA is an effective drug for various retinal and choroidal diseases when delivered intravitreally. It may imply an off-label use and it may be associated with ocular adverse events. Intravitreal TA is not associated with significant systemic safety risks.