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
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.
Available from: Jennifer Harthan
- "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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ABSTRACT: AzaSite(®) (azithromomycin 1.0%) ophthalmic solution was approved in 2007 by the US Food and Drug Administration (FDA) as the first commercially available formulation of ophthalmic azithromycin for the treatment of bacterial conjunctivitis. AzaSite(®) utilizes a vehicle delivery system called DuraSite(®), which stabilizes and sustains the release of azithromycin to the ocular surface, leading to a longer drug residence time, less frequent dosing, and an increase in patient compliance. AzaSite(®) is a broad spectrum antibiotic, effective against Gram-positive, Gram-negative, and atypical bacteria. AzaSite(®) has been studied for the treatment of ocular conditions beyond its clinical indication. A number of clinical studies have evaluated its efficacy and safety in the management of ocular conditions such as bacterial conjunctivitis and blepharitis on both the pediatric and adult populations. This article aims to evaluate the peer-reviewed published literature on the use of azithromycin 1.0% ophthalmic for current and possible future ophthalmic uses.
Opthalmology and Eye Diseases 02/2012; 4:1-14. DOI:10.4137/OED.S7791
Available from: Canan A Utine
- "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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ABSTRACT: Azithromycin is an azalide that acts by binding to the 50S ribosomal subunit of susceptible microorganisms and interfering with microbial protein synthesis. Azithromycin is also noted by anti-inflammatory and immunomodulatory activity. AzaSite(®) (Inspire Pharmaceuticals, Inc, Durham, NC) is azithromycin ophthalmic solution, 1% formulated in polycarbophil (the aqueous mucoadhesive polymer contained in DuraSite(®)) that delivers high and prolonged azithromycin concentrations in a variety of ocular tissues, including the conjunctiva, cornea and particularly the eyelid. AzaSite was approved by the Food and Drug Administration (FDA) in the US in 2007, for the treatment of bacterial conjunctivitis caused by susceptible isolates. This article aims to evaluate the peer-reviewed published scientific literature and to define well-established uses of AzaSite eye drops in the field of ocular infections.
Clinical Ophthalmology 06/2011; 5(1):801-9. DOI:10.2147/OPTH.S13785 · 0.76 Impact Factor
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ABSTRACT: The graph theory/network flow approach to the emergency-service
restoration problem is discussed. The mixer integer programming
formulation looks rigorous and concise. However, its usefulness appears
to be very limited due to computational difficulties. By introducing
artificial branches and a source and sink, the problem may be formulated
as a maximal-flow problem in a restricted sense. In this case, zero-one
decision variables representing switch status should be handled
separately after the solution to the completely connected network is
obtained. It is shown that the straight-forward application of the graph
theory/network flow approach is not suitable for the problem. This
simply points out difficulties associated with the problem and also
suggests that heuristic algorithms need to be used to handle problems of
Circuits and Systems, 1988., IEEE International Symposium on; 07/1988
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