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| |  Besifloxacin Ophthalmic Suspension as Effective as Moxifloxacin for Bacterial Conjunctivitis in Children: Presented at ARVO By Cameron Johnston FT. LAUDERDALE, Fla -- May 13, 2009 -- Besifloxacin ophthalmic suspension 0.6% appears to be as safe and effective as moxifloxacin in treating bacterial conjunctivitis in children, researchers stated here at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting. Timothy Comstock, Department of Global Pharmaceutical Affairs, Bausch and Lomb Inc., Rochester, New York, presented the study here on May 5. Besifloxacin ophthalmic suspension 0.6% was tested in 195 patients (331 eyes) and compared with 87 patients (138 eyes) who were treated with moxifloxacin. Full evaluable data were available for 142 children who received besifloxacin, including 36 who were aged younger than 2 years, and 63 children who received moxifloxacin (12 aged <2 years). Children with conjunctivitis received 1 drop of besifloxacin 0.6% in their eyes 3 times daily for 5 days. In the vehicle-controlled studies, clinical resolution was seen in 58.3% of besifloxacin-treated subjects (n = 84) at the second visit, 5 days after the first instillation, and 89.3% at the third visit, 8 days after the first instillation. This compares with clinical resolution of 47.4% and 75.6% of vehicle-treated patients at visits 2 and 3 respectively (n = 78). In the active-controlled studies, clinical resolution of the conjunctivitis in the besifloxacin group was seen in 72.2% of the children aged younger than 2 years and 77.5% of children aged 2 to 6 years. For children treated with moxifloxacin, these numbers were 83.3% and 78.4% respectively. Despite the numerical difference, these results were not statistically significant. All traces of the microbial organisms causing the conjunctivitis were eradicated in more children treated with besifloxacin (88.9% of children aged <2 years, and 95.0% of children aged >=2 years) compared with moxifloxacin (66.7% <2 years and 94.1% >=2 years). These differences were not statistically significant. As for treatment-emergent adverse effects, 3 out of 21 (14.3%) of children aged younger than 2 years who were treated with moxifloxacin developed further conjunctivitis compared with 2 out of 79 children (2.5%) treated with besifloxacin. Children receiving moxifloxacin were also more likely to develop further bacterial conjunctivitis, as well as eye discharge, to develop limbal hyperaemia, and more likely to complain about eye pain. There were no differences in adverse events recorded among children aged 2 to 6 years in either group. [Presentation title: Efficacy and Safety of Besifloxacin Ophthalmic Suspension 0.6% in Pediatric Patients With Bacterial Conjunctivitis. Abstract 2667-D899]
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