Efficacy and Tolerability of Besifloxacin Ophthalmic Suspension 0.6% Administered Twice Daily for 3 Days in the Treatment of Bacterial Conjunctivitis: A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study in Adults and Children

Silverstein, Bruce E.; Allaire, Catherine; Bateman, Kirk; Gearinger, Lynne S.; Morris, Timothy W.; Comstock, Timothy L.

doi:10.1016/j.clinthera.2010.12.004

Cited by 43 publications

(36 citation statements)

References 31 publications

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“…Thus, although the methicillin-resistance phenotype does not affect fluoroquinolone relative potency, ciprofloxacin resistance, which is often concurrent with methicillin resistance, did. Silverstein et al recently reported that the in vitro potency of besifloxacin was similar to that of vancomycin against staphylococcal isolates, including ciprofloxacin-resistant MRSA 36. Vancomycin is often used in the treatment of ocular MRSA infections 28,37,38…”

Section: Discussionmentioning

confidence: 99%

Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: etiology of bacterial conjunctivitis and antibacterial susceptibility profile

Haas¹,

Gearinger²,

Usner³

et al. 2011

OPTH

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BackgroundThe purpose of this paper is to report on the bacterial species isolated from patients with bacterial conjunctivitis participating in three clinical trials of besifloxacin ophthalmic suspension, 0.6%, and their in vitro antibacterial susceptibility profiles.MethodsMicrobial data from three clinical studies, conducted at multiple clinical sites in the US and Asia were integrated. Species were identified at a central laboratory, and minimum inhibitory concentrations were determined for various antibiotics, including β-lactams, fluoroquinolones, and macrolides.ResultsA total of 1324 bacterial pathogens representing more than 70 species were isolated. The most common species were Haemophilus influenzae (26.0%), Streptococcus pneumoniae (22.8%), Staphylococcus aureus (14.4%), and Staphylococcus epidermidis (8.4%). H. influenzae was most frequently isolated among patients aged 1–18 years, while S. aureus was most prevalent among those >65 years. Drug resistance was prevalent: Of H. influenzae isolates, 25.3% were β-lactamase positive and 27.2% of S. pneumoniae isolates were penicillin-intermediate/ resistant; of S. aureus isolates, 13.7% were methicillin-resistant (MRSA), and of these, 65.4% were ciprofloxacin-resistant, while 45.9% of S. epidermidis isolates were methicillin-resistant (MRSE), and, of these, 47.1% were ciprofloxacin-resistant. Besifloxacin was more potent than comparator fluoroquinolones overall, and particularly against Gram-positive bacteria. Against ciprofloxacin-resistant MRSA and MRSE, besifloxacin was four-fold to ≥ 128-fold more potent than other fluoroquinolones.ConclusionsWhile the pathogen distribution in bacterial conjunctivitis has not changed, drug resistance is increasing. Patient age and local antibiotic resistance trends should be considered in the treatment of this ocular infection. Besifloxacin showed broad-spectrum in vitro activity and was particularly potent against multidrug-resistant staphylococcal isolates.

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Section: Discussionmentioning

confidence: 99%

Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: etiology of bacterial conjunctivitis and antibacterial susceptibility profile

Haas¹,

Gearinger²,

Usner³

et al. 2011

OPTH

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“…Besifloxacin ophthalmic suspension 0.6% (Besivance ® ; Bausch and Lomb Inc, Rochester, NY) was approved in 2009 by the US Food and Drug Administration for ophthalmic use, and has been shown to be effective for the treatment of bacterial conjunctivitis 18–22. It is a topical chlorofluoroquinolone that targets both DNA gyrase and topoisomerase IV,23 and has been indicated for use against a broad range of bacteria, including Staphylococcus , Streptococcus , and Corynebacterium species 24.…”

Section: Introductionmentioning

confidence: 99%

Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study

Malhotra¹,

Gira²,

Berdy³

et al. 2012

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BackgroundThe purpose of this study was to evaluate the safety and tolerability of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5%, when used for infection prophylaxis following uncomplicated phacoemulsification clear cornea surgery using sutureless corneal incision.MethodsThis prospective, two-site, parallel-group, investigator-masked clinical study included patients aged ≥18 years scheduled to undergo phacoemulsification with intraocular lens implantation. Patients received one drop of either besifloxacin ophthalmic suspension or moxifloxacin ophthalmic solution four times daily, beginning 3 days prior to surgery, which was continued for 7 days postoperatively. The primary endpoint was the rate of adverse events. Secondary endpoints included endothelial cell count, central corneal thickness, and overall and central corneal staining measured on days 7 (±1 day) and 28 (±2 days) following surgery, and intraocular pressure and best-corrected visual acuity measured on days 1, 7 (±1 day), and 28 (±2 days) following surgery.ResultsOf the 60 patients enrolled, 58 (29 per treatment group) completed the study. No adverse events were reported in either treatment group. Changes in the central corneal thickness, endothelial cell count, and corneal staining were small and similar between treatments at follow-up visits (P ≥ 0.1549). Intraocular pressure was similar between treatment groups at each visit, as was the distribution of best-corrected visual acuity. The final best-corrected visual acuity was 20/30 or better in 85% of the patients.ConclusionIn this study, besifloxacin ophthalmic suspension 0.6% was well tolerated when used prophylactically to prevent postoperative endophthalmitis following sutureless cataract surgery.

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“…Samples for microbial cultures were taken from the conjunctival cul de sac of the affected eye(s), avoiding contact with eyelids, and patients were randomized to study treatment. Patients were instructed to administer one drop of study medication in the affected eye(s) three times daily at approximately 6-hour intervals for 5 days25–27 or twice daily at approximately 8-hour intervals during waking hours for a total of 3 days 28,29. Patients returned to the study site at or near the end of treatment (visit 2) and ≥48 hours after treatment ended (visit 3) for clinical assessment of ocular signs and symptoms, visual acuity testing, biomicroscopy, ophthalmoscopy (visit 3 only), and culture of infected eye(s).…”

Section: Methodsmentioning

confidence: 99%

“…It is currently approved for the treatment of bacterial conjunctivitis in the US, Canada, and some Latin American and Asian countries 23,24. Besifloxacin ophthalmic suspension was found to be safe and effective in the treatment of bacterial conjunctivitis in multicenter, randomized, double-masked, controlled clinical studies whether administered three times daily for 5 days25–27 or twice daily for 3 days 28,29. Besifloxacin has potent broad spectrum in vitro activity, including activity against P. aeruginosa .…”

Section: Introductionmentioning

confidence: 99%

Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with Pseudomonas aeruginosa infections

Silverstein

Morris²,

Gearinger³

et al. 2012

OPTH

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BackgroundThe purpose of this study was to determine the efficacy of besifloxacin ophthalmic suspension 0.6% when used in the treatment of bacterial conjunctivitis infections due to Pseudomonas aeruginosa.MethodsWe undertook a post hoc analysis of clinical outcomes in patients with bacterial conjunctivitis due to P. aeruginosa across four prospective, multicenter, double-masked, randomized, controlled, clinical studies of besifloxacin ophthalmic suspension 0.6%. Efficacy outcomes included bacterial eradication and clinical resolution of the baseline infection at follow-up visits. Bacterial eradication was defined as the absence of ocular bacterial species present at or above threshold at baseline, while clinical resolution was defined as grade 0 ocular discharge and bulbar conjunctival injection. Safety outcomes included the incidence of adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings. Patient outcomes were summarized and bacterial eradication and clinical resolution rates integrated.ResultsOf 1317 patients with culture-confirmed bacterial conjunctivitis across four clinical studies, nine (0.7%) were infected with P. aeruginosa at baseline, and of these, five were randomized to treatment with besifloxacin ophthalmic suspension 0.6%. Bacterial eradication of the baseline infection was observed at both follow-up visits in all five patients. Clinical resolution was achieved in two of five patients by the first follow-up visit and four of five patients by the second follow-up visit. There were no adverse events reported in these patients. There were no clinically meaningful biomicroscopy findings or changes in ophthalmoscopy or visual acuity.ConclusionThe incidence of bacterial conjunctivitis due to P. aeruginosa was low. Treatment of patients with P. aeruginosa infections with besifloxacin ophthalmic suspension 0.6% led to bacterial eradication of P. aeruginosa by the first follow-up visit and high rates of clinical resolution.

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Efficacy and Tolerability of Besifloxacin Ophthalmic Suspension 0.6% Administered Twice Daily for 3 Days in the Treatment of Bacterial Conjunctivitis: A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study in Adults and Children

Cited by 43 publications

References 31 publications

Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: etiology of bacterial conjunctivitis and antibacterial susceptibility profile

Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: etiology of bacterial conjunctivitis and antibacterial susceptibility profile

Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study

Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with Pseudomonas aeruginosa infections

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