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2003 OMIG, Abstract 12

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Intraocular Safety of Gatifloxacin in a Rabbit Model
R.W. Snyder1, M. Chang2, W. Hare3, M. Stem3, S. Donnenfeld4 and T. Kramer1. 1University of Arizona, Tucson, AZ, 2Janesville, WI, 3Allergan, Inc., Irvine, CA, 4North Shore Hospital, Long Island, NY, and 5Emory University, Atlanta, GA

Purpose: We believe that intracameral (IC) antibiotics may be useful to prevent endophthalmitis. In this study we assess the safety of an intraocular injection of gatifloxacin in the rabbit eye. Our goal of therapy is to achieve 2 x the susceptibility break point for Staph. epidermidis at 6 hours after injection. We evaluated toxicity of gatifloxacin concentrations that would achieve >4ugm/cc at 6 hours as well as concentrations which were 2.5 and 5 times greater.
Methods: Three groups of six New Zealand white rabbits received 0.05cc IC containing 367ugm/cc, 918ugm/cc, or 1836ugm/cc of gatifloxacin in one eye and BSS in the other (final concentration estimate 64ugm/cc, 160ugm/cc, and 320ugm/cc of aqueous). Animals were examined pre-injection and on days 1, 3, and 28 with slit lamp photography and intraocular pressure measurement Pachymetry was done on days 1 and 3. A second group of 7 animals received an intravitreous injection to yield a vitreal concentration of 160ugm/cc gatifloxacin in the right eye. They had recordings of the ERG and VECP as well as fundus photography at 1 day and 28 days post treatment. Tissue samples from all animals were obtained for histology at either 28 or 29 days post treatment.
Results: There were no significant changes in lOP at days 1, 3, and 28 and no change in pachymetry on days 1 and 3. Endothelial cell counts looked similar to control eyes in all but one of the 320ugm/cc rabbit eyes which was difficult to distinguish from artifact. There were no abnormalities seen on fundus photographs and the ERG and VECP responses were unaffected.
Conclusions: Gatifloxacin appears to be safe and well tolerated when injected at concentrations up to 320ugm/cc in the aqueous and 160ugm/cc in the vitreous.

Support: Allergan Pharmaceuticals, Inc., Irvine, CA


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