Elsevier

American Journal of Ophthalmology

Volume 140, Issue 3, September 2005, Pages 497.e1-497.e11
American Journal of Ophthalmology

Original article
Intracameral Vigamox® (Moxifloxacin 0.5%) is Non-Toxic and Effective in Preventing Endophthalmitis in a Rabbit Model

Data from this article has been presented at the 2004 Ocular Microbiology and Immunology Group meeting in New Orleans, Louisiana, and 2005 ARVO meeting in Fort Lauderdale, Florida.
https://doi.org/10.1016/j.ajo.2005.04.015Get rights and content

Purpose

To determine whether Vigamox® (moxifloxacin 0.5% ophthalmic solution) can be safely injected intracamerally to prevent Staphylococcus aureus endophthalmitis in a rabbit model.

Design

Animal study.

Methods

The safety and bactericidal-effectiveness of Vigamox® were evaluated in three stages using 189 New Zealand White rabbits. (Stage 1) The toxicity of two intravitreal doses of Vigamox® (moxifloxacin 500, 250 μg) was compared with vancomycin (1 mg) and saline. (Stage 2) A reproducible rabbit model of Staphylococcus aureus endophthalmitis was established. (Stage 3) The bactericidal effect of intracameral Vigamox® (moxifloxacin 500, 250, 125, 50 μg) was compared with vancomycin (1 mg) and saline. Intracameral antibiotic therapy commenced immediately after Staphylococcus aureus intravitreal challenge (5000 cfu). Toxicity was evaluated by masked clinical examination using a slit-lamp, an indirect ophthalmoscope, and corneal-ultrasound pachymetry. The clinical examination included the exterior eye, cornea, anterior chamber, vitreous, and retina. The presentations were graded on a severity scale of 0, 0.5, 1, 2, and 3. The bactericidal efficacy was determined using intracameral colony counts.

Results

In the toxicity studies without bacterial challenge, the clinical scores of rabbits injected intracamerally with Vigamox® were statistically equivalent to rabbits given intracameral vancomycin or saline. In the efficacy studies, eyes treated intravitreally with Vigamox®, at all doses, or vancomycin were negative for Staphylococcus aureus and nontreated controls remained culture-positive.

Conclusions

Vigamox® appears to be nontoxic for intracameral injection and effective in preventing experimental endophthalmitis in the rabbit model. Further studies will determine the clinical role of intracameral Vigamox® for surgical prophylaxis and postoperative therapy.

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.

References (15)

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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).

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