Ocular Toxicity in Beagle Dogs with an Experimental Fluoromethane-Sulfonanilide Sympathomimetic Agent

ABSTRACT

Ocular lesions were detected in Beagle dogs receiving high doses of BA6650, an experimental fluoromethane-sulfonanilide sympathomimetic agent, during a preclinical safety evaluation study. The oral dose of BA6650 was increased during the 14-day study from 20 mg/kg twice daily (bid) for days 1–3 to 30 mg/kg bid for days 4–6 and finally to 40 mg/kg bid for days 7–14. Two males and two females received BA6650 while one male and one female were not dosed. Intraocular pressure in the untreated controls fluctuated during the study between 17 and 22 mmHg. Intraocular pressure decreased in 3 of 4 BA6650 treated dogs from an initial mean value of 17 to a final mean value of 8 mmHg. Ocular lesions consisting of conjunctival hyperemia, corneal opacities, epiphora, mydriasis followed by miosis, corneal herniation, hypopyon, ptosis, and anterior synechia developed in three of the animals.