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2005 OMIG, Abstract 5

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Human Corneal Stroma and Epithelium Concentrations of Moxifloxacin and Gatifloxacin Following Topical Ocular Dosing with VIGAMOX® and ZYMAR ®

T Kim1, S Lane2, E Holland3, M Raizman4, S Dunn5, A Martin6, H Katz7, R Faulkner6, D Dahlin6, D Jasheway6, S Robertson6

1Duke University Eye Center, Durham NC 2Associated Eye Care, Stillwater MN 3Cincinnati Eye Institute, Cincinnati OH 4Ophthalmic Consultants of Boston, Boston MA 5Michigan Cornea Consultants, Southfield Ml 6Alcon Research, Ltd, Fort Worth, TX 7Krieger Eye Institute, Baltimore MD

Purpose: To evaluate the corneal penetration of moxifloxacin and gatifloxacin following topical administration of VIGAMOX® or ZYMAR® by measuring the concentrations of moxifloxacin and gatifloxacin in the'corneal stroma and epithelium of patients undergoing penetrating keratoplasty.

Methods: In a controlled, randomized, open-label, parallel, multi-center, multiple- dose study, corneas from 48 patients undergoing penetrating keratoplasty were analyzed following administration of either VIGAMOX® (moxifloxacin 0.5%) or ZYMAR® (gatifloxacin 0.3%). Prior to surgery, the study eye was treated with two doses of test article (one drop each) given 5 minutes apart, with the last pre- operative dose administered either 0.25, 0.5, 1, or 2 hours prior to corneal tissue sampling. Following excision of the corneal button, the sample was immediately placed in a storage container on dry ice and shipped for analysis. Samples were assayed using a validated simultaneous HPLC-fluorescence method.

Results: Peak stroma levels of moxifloxacin (48.5 ug/g) were 3-fold higher than those for gatifloxacin (15.7 ug/g). A 7-fold higher peak epithelium level was observed for moxifloxacin (81.2 ug/g) versus gatifloxacin (12.3 ug/g). Mean Cmax:MIC ratios for the most common endophthalmitis and keratitis pathogens (including atypical mycobacteria) were considerably higher for moxifloxacin than for gatifloxacin.

Conclusions: The superior corneal penetration and greater antimicrobial activity of moxifloxacin suggest that moxifloxacin would provide enhanced prophylaxis against endophthalmitis and keratitis pathogens.

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