An Anterior Chamber Toxicity Study Evaluating Besivance, AzaSite, and Ciprofloxacin

Department of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah, Salt Lake City, UT 84132, USA.
American Journal of Ophthalmology (Impact Factor: 3.87). 10/2010; 150(4):498-504.e1. DOI: 10.1016/j.ajo.2010.05.006
Source: PubMed


We determined whether Besivance (Bausch & Lomb), AzaSite (Inspire Pharmaceuticals, Inc; both with DuraSite bioadhesive [InSite Vision, Inc]) and ciprofloxacin are toxic inside the anterior chamber.
Randomized, masked, placebo-controlled animal study.
Twenty New Zealand white rabbits (40 eyes) were randomized to 1 of 4 study groups: Besivance, AzaSite, ciprofloxacin, and balanced salt solution. Each eye was injected with 0.1 mL of the study medication. Clinical slit-lamp examinations were conducted at 24 and 48 hours after injection. All rabbits then were killed and all eyes were enucleated. We randomized eyes to either corneal vital staining or histopathologic examination. The main outcome measures were clinical and pathologic signs of toxicity.
The 2 DuraSite-based study groups (Besivance and AzaSite) showed clinically and pathologically significant differences when compared with the ciprofloxacin and balanced salt solution groups. Besivance and AzaSite eyes exhibited significantly similar and severe clinical damage, including severe corneal edema. Ciprofloxacin and balanced salt solution eyes appeared very similar and had only mild conjunctival injection and limbal vascularity. Vital staining and histopathologic evaluation revealed glaucomatous and toxic damage in eyes given DuraSite-based medications, whereas non-DuraSite groups showed minimal changes.
DuraSite blocks the trabecular meshwork and may be additionally toxic when introduced as a large bolus. Until the safety of these medications is established with further studies using smaller injected volumes, we recommend placement of a suture over a clear corneal wound if DuraSite-based medications are used.

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    • "Azasite® has been shown to have high conjunctival tissue concentrations which could be helpful to prevent microbial infections, but the low aqueous humor concentrations make it less than ideal to treat endophthalmitis. One study evaluated the safety of DuraSite® if introduced into the anterior chamber.51 These results lead the authors to conclude that DuraSite® antibiotics could cause both acute glaucoma and anterior chamber toxicity. "
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    • "For the polycarbophil polymer (DuraSite), ocular topical administration at 0.6% and 1.3% concentrations to albino rabbits three times a day for at least 52 weeks was reported to elicit no evidence of ocular or systemic toxicity.27 However, in another randomized, masked, placebo-controlled animal study, DuraSite medications injected into the anterior chamber were found to induce acute inflammatory reaction with direct toxic effect and acute glaucoma by trabecular meshwork blockage.35 "
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