2003 OMIG, Abstract 10

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Human Aqueous Humor Penetration Pharmacokinetics of Moxifloxacin After Topical Administration of Moxifloxacin 0.5% Ophthalmic Solution
Katz HR¹, Masket S², Lane SS³, Sail K⁴, Orr SC⁵, McCue BA⁵, Faulkner RD⁵ Dahlin DC⁵. ¹Krieger Eye Institute, Baltimore, Maryland; ²Private practice, Beverly Hills, California; ³Private practice, Stillwater, Minnesota; ⁴Private practice, Bellflower, California; ⁵Alcon, Inc., Fort Worth, Texas.

Purpose: To investigate the aqueous humor pharmacokinetics of Moxifloxacin 0.5% Ophthalmic Solution.
Methods: In this open-label, sparse-sampling, pharmacokinetic study at 4 U.S. centers, 60 adults requiring cataract surgery were randomly allocated to 1 of 2 treatment regimens of Moxifloxacin 0.5% Ophthalmic Solution. On the day of surgery, Group I (n=30) received a preoperative regimen of 1 drop every 15 minutes for 4 doses in the eye undergoing surgery. Group 2 (n=30) received 1 drop four times a day on the day before surgery, and on the day of surgery received the same preoperative regimen as Group I. In both groups, the last dose was administered either 0.25, 0.50, 1, 2, or 3 hours before aqueous humor sampling. In both groups, 6 samples (from 6 eyes) were obtained at each sampling time. Moxifloxacin concentrations in the aqueous humor were analyzed by HPLC/MS/MS.
Results: For Group 1, mean CMAX was 1.50±0.85 ug/mL (range 0.840 to 3.03ug/mL). For Group 2, mean CMAX was 1.74±0.66ug/mL (range 0.678 to 2.44ug/mL). Analysis of the complete data set is in progress.
Conclusion: Moxifloxacin 0.5% Ophthalmic Solution penetrates the cornea and enters the aqueous humor. The maximum concentration far exceeded the MIC values for S. aureus and for S. epidermidis.

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