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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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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.
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.
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.
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
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