Concentration is Essential
- Low drug levels may allow resistant strains of bacterial mutations to develop in vitro*1
- Increasing the drug concentration to at least 3 times the MIC90 values of pathogens can reduce frequency of mutational resistance in vitro*2
High Tear Concentration in Healthy Volunteers*†3
- Rapidly achieves high tear concentrations within 15 minutes
- Tear concentrations still exceed the in vitro MIC90 values of common ocular pathogens at 24 hours
Approved dosing is 1-2 drops every 30 min - 2 hr on the first day. Refer to PI for complete dosing regimen
†The clinical significance of prolonged tear concentration has not been established.
High Sustained Corneal Concentrations*4,5
- Quickly penetrates to concentrations 3-26 times the MIC90 values of common ocular pathogens
- Sustained concentrations nearly 1.5 times the MIC90 value of S. aureus at 8 hours
- Penetrates cornea to concentrations 20-166 times the MIC90 values of common ocular pathogens
High Sustained Aqueous Concentrations*4,5
- Penetrates aqueous humor to concentrations nearly 2 times the MIC90 value of S. aureus
- Concentration levels still measurable at 12 hours
- Penetrates aqueous humor to concentrations that exceed 2 times the MIC90 value for S. aureus
*The clinical relevance of in vitro activity has not been established.
1. World Health Organization. Fact sheet No. 194. Antimicrobial resistance; Rev. January 2002. Available at: http://www.who.int/mediacentre/factsheets/fs194/en/print.html. Accessed July 11, 2007. 2. Bui DP, Dang SB, Hwang DG. Effect of ciprofloxacin concentration on mutational resistance rates in S. aureus. Invest Ophthalmol Vis Sci. 1995;36:Abstract 4876. 3. Walters TR, Hart W. Tear concentration of 1.5% levofloxacin ophthalmic solution following topical administration in healthy adult volunteers. Invest Ophthalmol Vis Sci. 2003;44:E-Abstract 4453. 4. Data on file, VISTAKON® Pharmaceuticals. Pharmacokinetic report for comparative ocular penetration of levofloxacin, moxifloxacin and gatifloxacin following single topical administration to the rabbit eye. Study No. 74202. 4. Data on file, VISTAKON® Pharmaceuticals. A randomized, observer-masked, parallel-group, multicenter trial evaluating the ocular penetration of 1.5% levofloxacin ophthalmic solution and 0.3% gatifloxacin ophthalmic solution in subjects undergoing corneal transplant surgery. Clinical Study Report 16-007R. August 2, 2005.


