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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