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T. L. Comstock, M. R. Paterno, J. A. Lynch, D. W. Usner; Efficacy and Safety of Besifloxacin Ophthalmic Suspension 0.6% in Pediatric Patients With Bacterial Conjunctivitis. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2667.
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© ARVO (1962-2015); The Authors (2016-present)
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 efficacy and safety of besifloxacin in pediatric subjects (<6 years of age).
Efficacy and safety data were drawn from 3 randomized, double-masked, parallel-group studies (two were vehicle-controlled and one was active-controlled with moxifloxacin ophthalmic solution 0.5%) of subjects with BC. Efficacy assessments included clinical resolution of baseline conjunctivitis and eradication of baseline infection; safety assessments included analysis of adverse events (AEs).
A total of 195 pediatric subjects were treated with besifloxacin (331 eyes); Efficacy data were available for 142 subjects with culture confirmed conjunctivitis, including 36 subjects less than 2 years of age. In the vehicle-controlled studies, clinical resolution was observed in 58.3% and 89.3% of besifloxacin-treated subjects (N=84) at visit 2 and visit 3 compared to 47.4% and 75.6% of vehicle-treated subjects (N=78), respectively, while microbial eradication was observed in 81.0% and 76.2% of besifloxacin-treated subjects compared to 51.3% and 65.4% of vehicle-treated subjects, respectively. In the active-controlled study, visit 2/visit 3 clinical resolution and microbial eradication in besifloxacin-treated subjects (N=58) were 75.9%/86.2% and 93.1%/82.8%, respectively; and 79.4%/87.3% and 88.9%/82.5% in moxifloxacin-treated subjects (N=63), respectively. The most commonly reported ocular AEs among all besifloxacin-treated eyes were conjunctivitis (2.1%, 7/331), bacterial conjunctivitis (1.8%, 6/331), conjunctival haemorrhage (1.2%, 4/331), viral conjunctivitis (1.2%, 4/331) and eye pain (1.2%, 4/331). Conjunctivitis as an adverse event was less frequently reported in subjects receiving besifloxacin than in subjects receiving vehicle.
Data from 3 trials with pediatric subjects demonstrate that besifloxacin ophthalmic suspension 0.6% is safe and effective in this patient population.
Clinical Trial: :
www.clinicaltrials.gov 00347932, 00622908, 00348348
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