December 2002
Volume 43, Issue 13
ARVO Annual Meeting Abstract  |   December 2002
Preclinical Safety of Ophthalmic Epinastine in Rabbits and Monkeys
Author Affiliations & Notes
  • B Brar
    Allergan Inc Irvine CA
  • C Vangyi
    Allergan Inc Irvine CA
  • K Tarlo
    Allergan Inc Irvine CA
  • B Short
    Allergan Inc Irvine CA
  • Footnotes
    Commercial Relationships    B. Brar, Allergan, Inc. E; C. Vangyi, Allergan, Inc. E; K. Tarlo, Allergan, Inc. E; B. Short, Allergan, Inc. E.
Investigative Ophthalmology & Visual Science December 2002, Vol.43, 108. doi:
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      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.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract: : 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  

Keywords: 390 drug toxicity/drug effects • 316 animal model 

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