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