April 2009
Volume 50, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2009
Besifloxacin Ophthalmic Suspension 0.6% Is Safe and Well Tolerated in Patients With Bacterial Conjunctivitis
Author Affiliations & Notes
  • M. R. Paterno
    Global Pharmaceutical Clinical Development,
    Bausch & Lomb, Rochester, New York
  • T. L. Comstock
    Global Pharmaceutical Medical Affairs,
    Bausch & Lomb, Rochester, New York
  • J. A. Lynch
    Global Pharmaceutical Clinical Development,
    Bausch & Lomb, Rochester, New York
  • D. W. Usner
    Global Pharmaceutical Clinical Development,
    Bausch & Lomb, Rochester, New York
  • Footnotes
    Commercial Relationships  M.R. Paterno, Bausch & Lomb, E; T.L. Comstock, Bausch & Lomb, E; J.A. Lynch, Bausch & Lomb, E; D.W. Usner, Bausch & Lomb, E.
  • Footnotes
    Support  Bausch & Lomb
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 2674. doi:
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      M. R. Paterno, T. L. Comstock, J. A. Lynch, D. W. Usner; Besifloxacin Ophthalmic Suspension 0.6% Is Safe and Well Tolerated in Patients With Bacterial Conjunctivitis. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2674.

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

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Abstract

Purpose: : Besifloxacin ophthalmic suspension 0.6% is a novel fluoroquinolone with demonstrated efficacy in the treatment of bacterial conjunctivitis (BC). This analysis sought to evaluate the safety and tolerability of besifloxacin.

Methods: : Safety and tolerability data were drawn from Phase I studies in healthy adults, from a pharmacokinetic study of patients with BC, and from pooled safety data from 3 randomized, double-masked, parallel-group studies (two were vehicle-controlled and one was active-controlled with moxifloxacin ophthalmic solution 0.5%) of patients with BC. Safety assessments included analysis of adverse events (AEs), changes in visual acuity, and ocular assessments with biomicroscopy and ophthalmoscopy.

Results: : Data were available for 1350 subjects, including 1192 (1810 eyes) in the pooled analysis (median age 27.5 years), who received besifloxacin. Topical administration of besifloxacin resulted in negligible systemic exposure; there were no changes in corneal endothelial cell density. In the pooled studies (Table), the most commonly reported ocular AEs were conjunctivitis (2.6%), blurred vision (2.1%), bacterial conjunctivitis (1.8%), eye irritation (1.4%), eye pain (1.5%), and eye pruritus (1.0%); conjunctivitis, blurred vision and eye irritation occurred in significantly fewer patients receiving besifloxacin than vehicle (P<0.025). Headache (1.8%) was the most frequently reported non-ocular AE. Most AEs were mild in severity, and there were no treatment related serious adverse events. Besifloxacin did not have a significant effect on visual acuity, biomicroscopy, or ophthalmoscopy compared with vehicle or moxifloxacin.

Conclusions: : Data from 6 trials with 1350 subjects demonstrate that besifloxacin ophthalmic suspension 0.6% is safe and well tolerated.

Clinical Trial: : www.clinicaltrials.gov 00347932, 00622908, 00348348

Keywords: antibiotics/antifungals/antiparasitics • conjunctivitis • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials 
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