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J.M. Griffin, O. Dembinska, R. Rice, J. Wheeler, J. Heaton, J. Hiddemen; A Ten–Week Toxicity Evaluation of VIGAMOX (0.5% moxifloxacin solution) Following a Single Intravitreal Injection in Nonhuman Primates . Invest. Ophthalmol. Vis. Sci. 2006;47(13):3578.
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To evaluate the ocular toxicity potential of VIGAMOX® (0.5% moxifloxacin solution) following a single intravitreal injection in the monkey.
In a 10 week study, either 60 µL of vehicle or 10, 20 or 60 µL of VIGAMOX (0, 50, 100 or 300 µg moxifloxacin, respectively) was administered via a single intravitreal injection into the right eyes of cynomolgus monkeys. The left eye of each animal served as an untreated, contralateral control. Ocular findings were assessed over a ten week period.
Slit lamp biomicroscopic examinations determined that all animals treated with VIGAMOX remained within normal limits during the study period. Indirect ophthalmic examination of the optic nerve head, retina, choroid and vitreous determined there that were no treatment related abnormal findings. Analyses of intraocular pressure (IOP) and corneal thickness revealed no adverse findings attributed to intravitreal injection of VIGAMOX. The group mean IOP values 8 days following injection of vehicle, 10, 20 or 60 µL VIGAMOX were 26.8 + 3.1, 25.1 + 4.1, 25.8 + 2.3, and 24.9 + 2.2 mmHg, respectively and the group mean corneal thickness values measured 8 days following injection were 466 + 38, 441 + 26, 446 + 17 and 458 + 33 microns, respectively. Specular image analysis determined there were no changes in the mean endothelial cell area or mean cell density following intravitreal injection of VIGAMOX. Histopathological examination of the eyes and adnexa revealed no treatment–related changes or evidence of ocular irritation.
Single intravitreal injection in monkeys of either 10, 20 or 60 µL of VIGAMOX was non–irritative and exhibited low potential for ocular toxicity over a ten week study period.
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