Purchase this article with an account.
B Brar, C Vangyi, K Tarlo, B Short; Preclinical Safety of Ophthalmic Epinastine in Rabbits and Monkeys . Invest. Ophthalmol. Vis. Sci. 2002;43(13):108.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Purpose:Ocular toxicity studies were conducted in rabbits and monkeys with epinastine hydrochloride ophthalmic solution, a new-generation histamine H1 receptor antagonist being developed for the treatment of allergic conjunctivitis. Methods:Epinastine hydrochloride (HCl) ophthalmic solution 0.05%, 0.1%, 0.5%, or placebo was administered in the left eye of New Zealand White rabbits (n=96) and cynomolgus monkeys (n=32) 3 times daily for 6 months. Results:No drug-related effects were seen on clinical signs, gross ocular observation, biomicroscopy, IOP, pupillary reflex, ophthalmoscopy, body/organ weight, hematology, serum chemistry, or histopathology. Pharmacokinetic parameters measured at 6 months showed very low systemic exposure that was dose-dependent. Conclusion:Ophthalmic epinastine is well tolerated in rabbits and monkeys. Long term administration does not produce ocular or systemic toxicity. Pharmacokinetic Parameters For Ophthalmic Epinastine View OriginalDownload SlideView OriginalDownload Slide
This PDF is available to Subscribers Only