Phase 3 Safety Comparisons for 1.0% Azithromycin in Polymeric Mucoadhesive Eye Drops versus 0.3% Tobramycin Eye Drops for Bacterial Conjunctivitis

Protzko, Eugene; Bowman, Lyle M.; Abelson, Mark B.; Shapiro, Aron

doi:10.1167/iovs.06-1413

Cited by 42 publications

(36 citation statements)

References 10 publications

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“…Bacteriologic eradication rates with azithromycin 1% for the most common causative pathogens ranged from 83 to 94%. 33 Rates of microbial eradication and bacterial infection recurrence were the same with azithromycin 1% and tobramycin 0.3% in studies by Abelson et al 34 and Protzko et al 35 Ocular adverse events with azithromycin include eye irritation, headache, worsening conjunctivitis, and conjunctival hyperemia and edema and are usually well tolerated by patients. 33,35 Azithromycin 1% ophthalmic solution offers twice-daily administration for 2 days followed by once-daily administration for 5 days (Table 2).…”

Section: Macrolidesmentioning

confidence: 91%

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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Section: Macrolidesmentioning

confidence: 91%

Limitations of Current Antibiotics for the Treatment of Bacterial Conjunctivitis

Karpecki

Paterno

Comstock

2010

Optometry and Vision Science

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“…The exclusive topical ophthalmic use of besifloxacin precludes any bacterial exposure resulting from systemic use, which reduces the likelihood of resistance development. Besifloxacin ophthalmic suspension 0.6% is formulated in a mucoadhesive polymer (DuraSite ® ; InSite Vision, Inc., Alameda, CA), designed to prolong the drug’s residence time on the ocular surface 16. The suspension includes 0.01% benzalkonium chloride as a preservative.…”

Section: Enhanced Technologies and Improved Therapeutics – Besifloxacinmentioning

confidence: 99%

Besifloxacin: a novel anti-infective for the treatment of bacterial conjunctivitis

Comstock¹,

Karpecki²,

Morris³

et al. 2010

OPTH

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Bacterial conjunctivitis, commonly known as pink eye, is demographically unbiased in its prevalence and can be caused by a variety of aerobic and anaerobic bacteria. Timely empiric treatment with a broad-spectrum anti-infective, such as a topical fluoroquinolone, is critical in preventing potentially irreversible ocular damage. However, the rise in ocular methicillin- resistant Staphylococcus aureus isolates and the patterns of fluoroquinolone resistance for patients with other ocular bacterial infections mandate the need for new agents targeted for ocular use. Besifloxacin, a novel broad-spectrum fluoroquinolone, is approved for the treatment of bacterial conjunctivitis. It has a uniquely balanced dual-targeting activity that inhibits both DNA gyrase and topoisomerase IV and is associated with a lower incidence of resistance development. Besifloxacin is not marketed in other formulations, ensuring that its exposure is limited to bacterial populations in and around the eye. This specifically precludes any bacterial exposure to besifloxacin resulting from systemic use, which further reduces the likelihood of emergence of bacterial resistance. In vitro, besifloxacin has demonstrated equivalent or superior activity compared with other commonly used topical antibiotics. In clinical trials, besifloxacin has consistently demonstrated efficacy and safety in the treatment of patients with bacterial conjunctivitis. Besifloxacin is considered safe and is well tolerated with no observed contraindications.

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“…Besifloxacin ophthalmic suspension 0.6% is formulated in a mucoadhesive polymer (DuraSite ® , InSite Vision., Inc., Alameda, CA), designed to prolong the drug's residence time on the ocular surface [29]. Besifloxacin ophthalmic suspension 0.6% includes 0.01% benzalkonium chloride (BAK) as a formulation preservative.…”

Section: Mechanism Of Actionmentioning

confidence: 99%

Besifloxacin, a new ophthalmic fluoroquinolone for the treatment of bacterial conjunctivitis

Bertino

Zhang

2009

Expert Opinion on Pharmacotherapy

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Besifloxacin is a new fluoroquinolone anti-infective developed for ophthalmic use. Besifloxacin ophthalmic suspension 0.6% (Besivance) was recently approved for the treatment of bacterial conjunctivitis. The objective of this article is to provide a comprehensive overview of microbiological, pharmacokinetic/pharmacodynamic and clinical studies with besifloxacin. Microbiological studies have demonstrated that besifloxacin has wide-spectrum and potent activity against common ocular pathogens, including Gram-negative and Gram-positive pathogens associated with bacterial conjunctivitis, and retained activity against fluoroquinolone-resistant staphylococci and multidrug-resistant strains. In preclinical and human studies, topically applied besifloxacin had a prolonged ocular concentration and minimal systemic exposure. In clinical studies, patients randomized to besifloxacin ophthalmic suspension 0.6% experienced significantly higher rates of clinical resolution and microbial eradication than patients randomized to vehicle. Besifloxacin ophthalmic suspension 0.6% was also found to be as effective and well tolerated as moxifloxacin ophthalmic solution 0.5%. The low minimum inhibitory concentrations and high attainment of pharmacodynamic targets with besifloxacin may contribute to a lower risk for the emergence of bacterial resistance, although further studies are needed. These data indicate that besifloxacin ophthalmic suspension 0.6% is an important new option for the treatment of bacterial conjunctivitis.

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Phase 3 Safety Comparisons for 1.0% Azithromycin in Polymeric Mucoadhesive Eye Drops versus 0.3% Tobramycin Eye Drops for Bacterial Conjunctivitis

Cited by 42 publications

References 10 publications

Limitations of Current Antibiotics for the Treatment of Bacterial Conjunctivitis

Limitations of Current Antibiotics for the Treatment of Bacterial Conjunctivitis

Besifloxacin: a novel anti-infective for the treatment of bacterial conjunctivitis

Besifloxacin, a new ophthalmic fluoroquinolone for the treatment of bacterial conjunctivitis

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