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M.V. Bergamini, J. Heaton, D. McGee, R. Hackett, J. Hiddemen; A Three Month Topical Ocular Toxicity Study of Moxifloxacin Ophthalmic Solutions in Cynomolgus Monkeys . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4457.
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Purpose: To determine the ocular irritation and systemic toxicity potential of moxifloxacin ophthalmic solutions in repeated-dose topical ocular studies in the monkey. Methods: In this 3 month study, 0% (vehicle), 0.5%, 1.0% or 3.0% moxifloxacin solutions were administered topically to the right eyes of Cynomolgus monkeys. Moxifloxacin solutions or vehicle (control) were instilled 6 times daily for the first 16 days and 3 times daily for the remainder of the 3 months. The left eye of each animal served as an untreated contralateral control. Body weights, ocular findings and clinical pathology were assessed during the study. Results: No adverse treatment-related clinical signs or body weight changes were observed during the three-month period. Indirect ophthalmoscopic and slit lamp biomicroscopic examinations determined that all animals treated with moxifloxacin solutions remained within normal limits during the study period. Statistical analyses of intraocular pressure, specular microscopy, pachymetry and clinical pathology measurements revealed no findings attributed to topical ocular treatment with moxifloxacin solutions. At necropsy, no treatment-related gross observations or effects on the absolute or relative organ weights were observed. AUC values at the time of maximum exposure [Day 14] ranged from 47 to 265 ng-hr/mL. The increase in AUC between Days 1 and 14 was minimal across the dose range, indicating little accumulation of drug in plasma. The maximum individual plasma drug concentration observed in this study was 216 ng/mL. Histopathological examination of the eyes and adnexa revealed no treatment-related changes or evidence of ocular irritation. Histopathological examination of non-ocular tissues from male and female monkeys indicated no changes attributed to topical administration of moxifloxacin solutions. Three months of topical ocular treatment with 0.5%, 1.0% or 3.0% moxifloxacin solution did not elicit any treatment-related toxicity. Conclusions: Based on the results of this 3 month evaluation in monkeys, topical ocular application of 0.5% to 3.0% solutions of moxifloxacin was not toxic and exhibited low potentials for ocular irritation and ocular or systemic toxicity.
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