Original articleIntracameral Vigamox® (Moxifloxacin 0.5%) is Non-Toxic and Effective in Preventing Endophthalmitis in a Rabbit Model
Section snippets
Methods
The safety and bactericidal efficacy of Vigamox® were evaluated in three stages using 189 New Zealand White (NZW) rabbits. (Stage 1) The toxicity of 100 μl and 50 μl of intracameral Vigamox®, equivalent to 500 μg and 250 μg of moxifloxacin, was compared with intracameral vancomycin (1 mg) (standard intracameral dose for endophthalmitis therapy)5 and saline. (Stage 2) A reproducible rabbit model of Staphylococcus aureus endophthalmitis was established. (Stage 3) The bactericidal effect of 100,
Stage 1 - toxicity studies
Table 1 presents the toxicity data as median total scores for noninfected rabbits that were administered intracameral injections of Vigamox®, vancomycin, or saline. Table 2 summarizes the statistical score analysis of all the clinical parameters. The total clinical scores were statistically equivalent for Vigamox® (100 μl, 50 μl), vancomycin, and saline. The total clinical scores (regardless of treatment) were higher on day 1 than on day 3 and day 7. Analysis indicated that this was mainly from
Discussion
Any new antibiotic therapy must be relatively nontoxic to the patient, effective in eliminating the infection, and be at least comparable or better than standard therapy. Moxifloxacin, before the FDA approval of Vigamox®, had been approved by the FDA (December 10, 1999) as Avelox (Bayer Corporation, West Haven, Connecticut, USA) for the systemic treatment of bacterial infections of the lungs, sinuses, and skin. Although considered relatively safe, systemic administration of Avelox is
Regis P. Kowalski, MS, [M]ASCP, University of Pittsburgh, Pittsburgh, Pennsylvania; Assistant Professor of Ophthalmology; Associate Clinical Medical Director, Charles T. Campbell Ophthalmic Microbiology Laboratory; Clinical Ophthalmic Microbiologist (University of Pittsburgh Medical Center). His research interests include: clinical microbiology testing, antibiotic discovery and testing.
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Regis P. Kowalski, MS, [M]ASCP, University of Pittsburgh, Pittsburgh, Pennsylvania; Assistant Professor of Ophthalmology; Associate Clinical Medical Director, Charles T. Campbell Ophthalmic Microbiology Laboratory; Clinical Ophthalmic Microbiologist (University of Pittsburgh Medical Center). His research interests include: clinical microbiology testing, antibiotic discovery and testing.
Eric G. Romanowski, MS, is the Associate Research Director of the Charles T. Campbell Ophthalmic Microbiology Laboratory at the UPMC Eye Center, Ophthalmology and Visual Sciences Research Center, Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, PA. He is also a member of the Institutional Animal Care and Use Committee (IACUC) at the University of Pittsburgh. His primary research interests include ocular antiviral and antibiotic development and the pathogenesis of ocular adenovirus infections.
This research project was supported by a grant from Alcon Laboratories, Inc, Fort Worth, Texas. The agreement between the University of Pittsburgh, Pittsburgh, Pennsylvania, and Alcon Laboratories states that the authors have the right to publish the data regardless of the study outcome. Alcon Laboratories did review the study protocol and were granted the courtesy to review the manuscript before submission but did not have any role in collection, management, analysis, and interpretation of the data.
The authors are paid consulting fees from Alcon Laboratories (Ft. Worth, Texas).