Safety and Tolerability of Besifloxacin Ophthalmic Suspension 0.6% in the Treatment of Bacterial Conjunctivitis

Comstock, Timothy L.; Paterno, Michael R.; DeCory, Heleen H; Usner, Dale W

doi:10.2165/11536720-000000000-00000

Cited by 16 publications

(13 citation statements)

References 23 publications

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“…A pooled analysis of safety data from these three clinical studies reported that the most commonly reported ocular adverse events in besifloxacin-treated patients were, in order of frequency, blurred vision (2.1 %), eye pain (1.8 %), eye irritation (1.4 %), conjunctivitis (1.2 %), and eye pruritus (1.1 %) [18]. Blurred vision, eye irritation, and conjunctivitis were reported significantly less frequently by besifloxacin-treated patients than by patients given vehicle [18]. In the study comparing besifloxacin and moxifloxacin, eye irritation was significantly less common for besifloxacin-treated eyes (0.3 %) than in moxifloxacin-treated eyes (1.4 %; p = 0.02) [15].…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2013

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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.

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Section: Discussionmentioning

confidence: 99%

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

et al. 2013

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“…In this way, the study concluded that besifloxacin ophthalmic suspension 0.6% is well tolerated and has satisfactory safety profile. [40] Silverstein and coworkers (2011) evaluated the efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% when administrated twice daily for 3 days, in adults and children with bacterial conjunctivitis. Bacterial conjunctivitis, conjunctivitis, and allergic conjunctivitis were the most related adverse events, in a low percentage (<1.9%) and of mild or moderate severity.…”

Section: Side Effectsmentioning

confidence: 99%

Besifloxacin: A Critical Review of Its Characteristics, Properties, and Analytical Methods

Tótoli

Salgado

2018

Critical Reviews in Analytical Chemistry

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Bacterial conjunctivitis has high impact on the health of the population, since it represents more than a third of ocular pathologies reported by health services worldwide. There is a high incidence of bacterial resistance to the antimicrobials most commonly used for the treatment of conjunctivitis. In this context, besifloxacin stands out, since it is a fluoroquinolone developed exclusively for topical ophthalmic use, presenting a low risk of developing resistance due to its reduced systemic exposure. Bausch & Lomb markets it as ophthalmic suspension, under the trade name Besivance™. Literature review on besifloxacin is presented, covering its pharmaceutical and clinical characteristics, and the analytical methods used to measure the drug in pharmaceutical products and biological samples. High performance liquid chromatography is the most used method for this purpose. A discussion on Green Chemistry is also presented, focusing the importance of the development of green analytical methods for the analysis of drugs.

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“…53 The ophthalmic preparations of the fluoroquinolones ciprofloxacin, ofloxacin, levofloxacin, and gatifloxacin require more frequent administration (e.g., every 2 h for 2 days, then four times a day for the next 5 days) than moxifloxacin, which is administered 3 times a day for 7 days, and besifloxacin, which is administered 3 times a day at 4 to 12 h intervals for 7 days (Table 2). 6,11,12,54,55 Fluoroquinolone ophthalmic preparations are well tolerated 43,45,47,50,51,56 and are associated with less toxicity than older antibiotics. 10,11,12,23 Ocular adverse events with topical fluoroquinolones generally are mild and self-limiting and have included conjunctivitis, pruritus, discomfort, transient burning, stinging, and photophobia.…”

Section: Fluoroquinolonesmentioning

confidence: 99%

Limitations of Current Antibiotics for the Treatment of Bacterial Conjunctivitis

Karpecki

Paterno

Comstock

2010

Optometry and Vision Science

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Bacterial conjunctivitis is a common ocular infection that is generally treated empirically with a broad-spectrum antibiotic. The more common pathogens causing bacterial conjunctivitis include Staphylococcus aureus, Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus epidermidis, and Moraxella species. Several antibiotics traditionally used to treat bacterial conjunctivitis are no longer widely prescribed because of increased bacterial resistance and/or safety concerns. The introduction of the fluoroquinolone class of anti-infectives offered effective and better tolerated treatment options. Nonetheless, successful therapy for bacterial conjunctivitis continues to be limited by several factors. A primary concern is the development of bacterial resistance that may be impacted not only by widespread antibiotic use but also by antibacterial pharmacokinetics, such as maintenance of insufficient bactericidal concentrations at the site of infection. In addition, poor adherence to prescribed regimens that require frequent administration, along with undesirable adverse events, affects the development of bacterial resistance and the success of treatment regimens. This article reviews current antibacterial agents used to treat bacterial conjunctivitis, factors that limit their successful use in treatment, and options for future development of more effective topical ophthalmic anti-infective agents.

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Safety and Tolerability of Besifloxacin Ophthalmic Suspension 0.6% in the Treatment of Bacterial Conjunctivitis

Abstract: The results from this comprehensive data set of 1350 patients demonstrate that besifloxacin ophthalmic suspension 0.6% has a favourable safety profile and is well tolerated.

Cited by 16 publications

References 23 publications

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

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

Besifloxacin: A Critical Review of Its Characteristics, Properties, and Analytical Methods

Limitations of Current Antibiotics for the Treatment of Bacterial Conjunctivitis

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