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November 1991

Secondary Glaucoma and Uveitis Associated With Orcolon-Reply

Author Affiliations

Azusa, Calif

Arch Ophthalmol. 1991;109(11):1497-1498. doi:10.1001/archopht.1991.01080110030019

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In Reply.  —The viscoelastic agent, Orcolon, received premarket approval from the Food and Drug Administration in March 1991. More than 4 years of preclinical and clinical work was performed to establish clinical safety and efficacy. Since this is a response to speculation about possible product toxicity, it must by nature appear somewhat defensive.In vitro studies were performed for testing mutagenicity, hemolytic activity, cell growth inhibition, and cytotoxicity. In vivo studies included tests for oral toxic effects, dermal sensitization, ocular irritation, and intraocular toxic effects. From these studies it was established that Orcolon (and its extract) is nonmutagenic, does not lyse red blood cells, and is neither inhibitory nor toxic to mammalian cells in culture. Moreover, after oral administration in rats; dermal application or injections in rabbits, guinea pigs, and humans; and ocular or intraocular instillation in rabbits and monkeys, Orcolon was found to be both nontoxic and nonsensitizing.Data

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