An anterior chamber toxicity study evaluating Besivance, AzaSite, and Ciprofloxacin

Am J Ophthalmol. 2010 Oct;150(4):498-504.e1. doi: 10.1016/j.ajo.2010.05.006. Epub 2010 Aug 3.

Abstract

Purpose: 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.

Design: Randomized, masked, placebo-controlled animal study.

Methods: 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.

Results: 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.

Conclusions: 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.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetates / administration & dosage
  • Animals
  • Anterior Chamber / drug effects*
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / toxicity*
  • Azepines / administration & dosage
  • Azepines / toxicity*
  • Azithromycin / administration & dosage
  • Azithromycin / toxicity*
  • Ciprofloxacin / administration & dosage
  • Ciprofloxacin / toxicity*
  • Corneal Opacity / chemically induced
  • Drug Combinations
  • Drug Delivery Systems*
  • Female
  • Fluoroquinolones / administration & dosage
  • Fluoroquinolones / toxicity*
  • Glaucoma / chemically induced
  • Intraocular Pressure / drug effects
  • Male
  • Minerals / administration & dosage
  • Rabbits
  • Random Allocation
  • Sodium Chloride / administration & dosage
  • Trabecular Meshwork / drug effects

Substances

  • Acetates
  • Anti-Bacterial Agents
  • Azepines
  • BSS solution
  • Drug Combinations
  • Fluoroquinolones
  • Minerals
  • Sodium Chloride
  • Ciprofloxacin
  • Azithromycin
  • besifloxacin