Lower Cytotoxicity than Gatifloxacin and Moxifloxacin in Human Cells*1

  • Human corneal endothelial cell and corneal keratocyte cytotoxicity were evaluated in vitro at clinically relevant concentrations and at multiple exposure times

 

Comprehensive Evaluation of Ocular Toxicity in Rabbits*2

  • No ocular toxicity was demonstrated in rabbits after administration of levofloxacin concentrations up to and including 3%
    • Ocular toxicity was measured under various treatment regimens, including multiple daily dosing for up to 26 weeks

Well-Tolerated Concentration With Little or No Stinging

  • Preservative-free, near neutral pH formulation
  • Comfortable administration for patients
  • The ocular adverse events occurring in 1%-2% of patients included decreased/blurred vision, instillation site irritation/discomfort, ocular infection, and ocular pain/discomfort
  • The non-ocular adverse events occurring in approximately 8%-10% of patients were headache and taste disturbance

*Clinical relevance of in vitro cytotoxicity and in vivo animal data has not been established.

1. Skelnik DL, Clark LA, Bezwada P. In vitro effect of drug concentration and exposure time of levofloxacin, ofloxacin, ciprofloxacin, gatifloxacin, and moxifloxacin on human corneal endothelial cells and keratocytes. Presented at: ARVO Annual Meeting; May 4-9, 2003. Ft. Lauderdale, Fla. Poster #4739.

2. Clark L, Bezwada P, Hosoi K, et al. Comprehensive evaluation of ocular toxicity of topical levofloxacin in rabbit and primate models. J Toxicol Cutan Ocul Toxicol. 2004;23(1):1-18.