[Preservative-free triamcinolone versus purified triamcinolone preparations].
BACKGROUND
Intravitreal injections of triamcinolone are not only an important therapeutic tool for a variety of vitreo-retinal disorders, but can also be employed for visualisation of the vitreous during pars plana vitrectomy. Triesence® is a preservative-free triamcinolone suspension that has been approved for visualisation during vitrectomy via intravitreal administration and as intravitreal therapy for certain rare ocular diseases. However, the differences between Triesence® and purified (and thus also preservative-free) triamcinolones such as Volon A® or Kenalog® are not well specified, although the manufacturer of Triesence® advertises the product as "specifically formulated for the eye".


METHODS
The publicly available FDA application material and information provided by the manufacturer for Triesence®, Kenalog® and Volon A® were analysed with respect to the differences between Triesence® and older triamcinolone preparations.


RESULTS
According to the publicly available FDA documents the approval of Triesence mainly was based on studies that have been conducted with the older triamcinolone preparations Kenalog® or purified Volon A®. Apart from the absence of preservative the differences between Triesence® and the "older" triamcinolone preparation seem marginal. Published experimental or clinical studies in respect to the possible advantages of Triesence® compared to Kenalog® or Volon A® are lacking. Triesence® has been approved for sympathetic ophthalmia, temporal arteriitis, uveitis unresponsive to topical corticosteroids and for enhancing tissue visualisation during vitrectomy. Recently, the manufacturer of Kenalog® added a warning label ("not for intraocular use") on each vial of Kenalog®. The motifs for this re-labelling of Kenalog® remain unclear.


CONCLUSIONS
Apart from the intraoperative use during vitrectomy Triesence® has only been approved for sympathetic ophthalmia, temporal arteriitis, and ocular conditions unresponsive to topical steroids. Consequently, the use of Triesence® like the older triamcinolone preparations (Kenalog® or Volon A®) for diabetic macular oedema, for Irivine-Gass syndrome, for neovascular AMD or after retinal vein occlusion is off-label.
Augenklinik, Department für Augenheilkunde, Universitätsklinikum Tübingen. martin.spitzer@med.unituebingen.de
M S
MS
Spitzer
F
F
Ziemssen
E
E
Yörük
K U
KU
Bartz-Schmidt
M
M
Schultheiss
P
P
Szurman
D005260:Female; D006801:Humans; D008297:Male; D009879:Ophthalmia, Sympathetic / Q000188:drug therapy*; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects / Q000737:chemistry*; D012164:Retinal Diseases / Q000188:drug therapy*; D014222:Triamcinolone Acetonide / Q000009:adverse effects / Q000737:chemistry* / Q000627:therapeutic use*
D011310:Preservatives, Pharmaceutical; D014222:Triamcinolone Acetonide