The Safety of Besifloxacin Ophthalmic Suspension 0.6 % Used Three Times Daily for 7 Days in the Treatment of Bacterial Conjunctivitis

Abstract

BackgroundBesifloxacin ophthalmic suspension 0.6 % (Besivance®; Bausch & Lomb, Rochester, NY, USA) was approved by the FDA in 2009 for the treatment of bacterial conjunctivitis, with a recommended 7-day dosing regimen.ObjectiveThe objective of this study was to compare the safety of besifloxacin ophthalmic suspension 0.6 %, administered three times a day for 7 days, with that of its vehicle.MethodsThis randomized, multicenter, double-masked, vehicle-controlled, parallel-group study involved 518 patients ≥1 year of age with a clinical diagnosis of bacterial conjunctivitis. Patients were randomized 2:1 to treatment with besifloxacin 0.6 % ophthalmic suspension or vehicle, one drop in the infected eye(s) TID for 7 days. Main outcomes included the incidence and types of adverse events reported by the subject or observed by the investigator at each study visit.ResultsThirty-one ocular treatment-emergent adverse events (TEAEs) were reported by 28 subjects in the study eye; 19 occurred in 17/344 (4.9 %) besifloxacin patients, and 12 occurred in 11/170 (6.5 %) vehicle patients (p = 0.5362). Only two ocular events (mild instillation site reaction, one case in each group) were considered “definitely related” to study treatment. One event of self-limited dysgeusia in the besifloxacin group was considered definitely related to treatment; there were no other nonocular TEAEs considered related to treatment. There were no serious adverse events, and other safety outcomes (visual acuity, biomicroscopy, ophthalmoscopy) were unremarkable.ConclusionThese findings indicate that besifloxacin ophthalmic suspension 0.6 % is safe in patients aged 1 year and older when used TID for 7 days.

Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6%

“…A chlorinated fluoroquinolone, besifloxacin has potent activity against both Gram-positive and Gram-negative bacteria, including multidrugresistant strains [25][26][27], and is rapidly bactericidal [28][29][30]. Besifloxacin is formulated with DuraSite 1 (Sun Pharma Global FZE), which helps increase retention on the ocular surface, and has demonstrated effectiveness in several bacterial conjunctivitis clinical trials [31][32][33][34][35][36].…”

Besifloxacin: Efficacy and Safety in Treatment and Prevention of Ocular Bacterial Infections

“…More recently, Malhotra et al [ 90 ] examined the safety of besifloxacin used 3 times daily for 7 days—the FDA-established recommended dosing regimen—in 514 patients with bacterial conjunctivitis in a randomized, multicenter, vehicle-controlled, parallel-group study. The rates of ocular treatment-emergent adverse events were similar for besifloxacin-treated and vehicle-treated patients (4.9% vs. 6.5%, P = 0.5362).…”

Besifloxacin in the management of bacterial infections of the ocular surface

“…48 Besifloxacin administered tid for 7 days was safe and well-tolerated, with similar rates of treatment-emergent AEs as for vehicle. Similarly, besifloxacin dosed bid was found to be safe in comparison with vehicle.…”