Abstract
Purpose: :
To evaluate the corneal penetration of moxifloxacin (moxi) and gatifloxacin (gati) following topical ocular administration of VIGAMOX or ZYMAR by measuring the concentrations of moxi and gati in corneal tissue and aqueous humor (AH) of patients undergoing penetrating keratoplasty (PK).
Methods: :
In a controlled, randomized, open–label, multiple–dose study, corneas from 48 patients undergoing PK were analyzed following administration of either VIGAMOX (moxifloxacin 0.5%) or ZYMAR (gatifloxacin 0.3%). Prior to surgery, the study eye was treated with 2 doses of test article (1 drop per dose) given 5 minutes apart, with the last dose at 0.25, 0.5, 1, or 2 hours prior to AH and cornea collection. Following AH sampling and excision of the corneal button, samples were placed on dry ice and shipped for analysis. Corneas were dissected into epithelium, stroma and endothelium and were assayed using a validated simultaneous HPLC–fluorescence method.
Results: :
The mean peak epithelial level of moxi (81.2 µg/g) was approximately 7–fold higher than that for gati (12.3 µg/g). A 3–fold higher peak stromal level was observed for moxi (48.5 µg/g) versus gati (15.7 µg/g). A mean peak endothelial level of moxi (76.1 µg/g) was approximately 10–fold higher than that for gati (7.3 µg/g). Consistent with prior clinical studies, the mean peak AH level of moxi was approximately 3–fold higher than gati. Peak levels of moxi were considerably higher relative to MIC values for the most common endophthalmitis and keratitis pathogens (including atypical mycobacteria).
Conclusions: :
The higher corneal and AH concentrations and greater antimicrobial activity of moxi demonstrate that VIGAMOX provides enhanced activity against common ocular pathogens associated with endophthalmitis and keratitis. Licensed to Alcon, Inc. by Bayer AG
*Zymar is a reg. tm of Allergan, Inc.
Keywords: antibiotics/antifungals/antiparasitics