Patients treated with intravitreal triamcinolone acetonide.

The paper by Kocabora and coworkers (2008) underlines the message that patients treated with intravitreal triamcinolone acetonide are at risk of increased intraocular pressure (IOP) even after the clearance period of the drug. Furthermore, the development of intractable secondary glaucoma requiring surgical intervention is clear advice to monitor these patients carefully. However, the study was performed in the period 2003–2006, before the prescribing information for the drug changed in 2007. The new information states that the intravitreal use of triamcinolone acetonide is not suggested because the high risk of complications, particularly because of the increase of IOP. After this modification, intravitreal triamcinolone acetonide is now an against-label and no more an off-label drug. Currently, other drugs based on triamcinolone from different producers can be injected in vitreous. A recently introduced micronized gel triamcinolone (on-label for vitreous staining during vitreoretinal surgery) if used for intravitreal therapy (AMD, Myopia, Diabetes, CRVO/BRVO) is also correlated with increased IOP increase and can lead to filtering surgery in more than 50% of patients. In these cases the filtering surgery is frequently ineffective, leading to valve surgery in more than 25% of all cases. It must be underlined that this intravitreal use is absolutely off-label and that micronized triamcinolone is not a drug, but a surgical device. To remain adherent to the on-label indications (verified by GCP trials) is mandatory for routine therapy. The European Commission document for “‘Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use, April 2004” is a useful guide to communicate these adverse reactions to the central national/supranational Agency (EMEA, FDA). Pharmacovigilance is always important and the Ophthalmological Community must continue to be aware of the potential harm of these important drugs.