title: Further characterization of ocular safety profile of commercially available preserved and preservative-free triamcinolone acetonide.
abstract: OBJECTIVE
  To characterize the safety profile of triamcinolone acetonide (TA) for intraocular application.
  
  
  METHODS
  In vitro cell viability assay was performed on 2 types of human ocular cells to evaluate the cytotoxicity of the simulated different vitreal concentrations (from a 1:15 dilution as if injected into 1.5 mL of rabbit vitreous to 1:50 dilution as if injected into 5 mL of human vitreous) of preservative and excipient (supernatant) from Kenalog-40. In vivo 35 guinea pigs were used for evaluating either a dose of intravitreal triamcinolone acetonide (Kenalog-40 and Triesence) or the supernatant of Kenalog-40. The animal eyes were monitored by biomicroscopy, ophthalmoscopy, tonometry, electroretinography, and histology.
  
  
  RESULTS
  A ≥ 1:15 dilution of triamcinolone acetonide supernatant from Kenalog-40 did not show cytotoxicity on cultured human pigment epithelial (retinal pigment epithelium) cells or Müller cells. In vivo, neither intravitreal 6 μL (0.248 mg, equivalent to 4 mg in 0.1 mL for human eyes) nor 18 μL (0.744 mg, equivalent to 4 mg in 0.1 mL for rabbit eyes and equivalent to 12 mg in 0.1 mL for human eyes) of triamcinolone acetonide suspension showed ocular toxicity. No significant difference was noted between Kenalog-40 and Triesence clinically and histopathologically.
  
  
  CONCLUSIONS
  The equivalent triamcinolone acetonide doses to 0.1 mL (4 or 12 mg) intravitreal injection for human eye were found safe in guinea pig eyes. No significant difference was noted for 0.1 mL intravitreal injection between Kenalog-40 and Triesence.
authors: Institute of Ocular Pharmacology, School of Ophthalmology and Optometry, Wenzhou Medical College, Wenzhou, Zhejiang, China.
authors: Yuli
authors: Y
authors: Li
authors: Hao
authors: H
authors: Chen
authors: Jiangping
authors: J
authors: Hou
authors: Yin
authors: Y
authors: Zhang
authors: Guoxing
authors: G
authors: Li
authors: Xin
authors: X
authors: Gu
authors: Li
authors: L
authors: Luo
authors: Huanjun
authors: H
authors: Shen
authors: Jia
authors: J
authors: Qu
authors: Lingyun
authors: L
authors: Cheng
mesh_terms: D000818:Animals; D017209:Apoptosis / Q000187:drug effects*; D019905:Benzyl Alcohol / Q000633:toxicity*; D002470:Cell Survival; D002478:Cells, Cultured; D004338:Drug Combinations; D004596:Electroretinography; D005938:Glucocorticoids / Q000633:toxicity*; D006168:Guinea Pigs; D006801:Humans; D058449:Intravitreal Injections; D008365:Manometry; D009457:Neuroglia / Q000187:drug effects* / Q000502:physiology; D009887:Ophthalmoscopy; D011310:Preservatives, Pharmaceutical / Q000633:toxicity*; D012160:Retina / Q000187:drug effects / Q000502:physiology; D055213:Retinal Pigment Epithelium / Q000187:drug effects* / Q000502:physiology; D014222:Triamcinolone Acetonide / Q000633:toxicity*
chemical_list: D004338:Drug Combinations; D005938:Glucocorticoids; D011310:Preservatives, Pharmaceutical; D014222:Triamcinolone Acetonide; D019905:Benzyl Alcohol