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2003
OMIG, Abstract 12
OMIG
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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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