Besifloxacin ophthalmic suspension 0.6%.
Besifloxacin is a novel fluoroquinolone that, like other fluoroquinolones, acts by inhibiting the essential bacterial enzymes DNA gyrase and topoisomerase IV. Topical besifloxacin ophthalmic suspension 0.6% is indicated for use in patients with bacterial conjunctivitis caused by susceptible bacteria. Besifloxacin had in vitro activity against a broad spectrum of Gram-positive and -negative bacteria that commonly cause ocular infections (e.g. Haemophilus influenzae, Staphylococcus aureus, S. epidermidis and Streptococcus pneumoniae), including drug-resistant strains. In two randomized, double-blind, multicentre trials, besifloxacin ophthalmic suspension 0.6% administered at the recommended dose for 5 days in patients aged > or =1 year with bacterial conjunctivitis was significantly (p < 0.01) more effective than vehicle in terms of clinical resolution and microbial eradication rates (coprimary endpoints) at study visit two (day 5+/-1) or three (day 8 or 9) [primary timepoints]. Besifloxacin ophthalmic suspension 0.6% was noninferior to moxifloxacin ophthalmic solution 0.5% in patients aged > or =1 year with bacterial conjunctivitis with regard to clinical resolution (58.3% vs 59.4%) and microbial eradication (93.3% vs 91.1%) rates on day 5 +/- 1 of treatment (coprimary endpoints) in a randomized, double-blind, multicentre trial; both drugs were administered at a dosage of one drop in the affected eye(s) three times daily for 5 days. Besifloxacin ophthalmic suspension 0.6% was generally well tolerated in clinical trials, with most adverse events being mild in severity. The tolerability profile of besifloxacin ophthalmic suspension 0.6% was similar to that of moxifloxacin ophthalmic solution 0.5%.
Carter
Natalie J
NJ
Adis, a Wolters Kluwer Business, Auckland, New Zealand. demail@adis.co.nz
Scott
Lesley J
LJ
D000287:Administration, Topical; D000900:Anti-Bacterial Agents / Q000494:pharmacology; D000935:Antifungal Agents / Q000494:pharmacology; D001372:Aza Compounds / Q000494:pharmacology / Q000627:therapeutic use; D001381:Azepines / Q000627:therapeutic use*; D015169:Colony Count, Microbial; D003234:Conjunctivitis, Bacterial / Q000188:drug therapy; D027081:DNA Gyrase / Q000378:metabolism; D027101:DNA Topoisomerase IV / Q000378:metabolism; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005123:Eye; D024841:Fluoroquinolones / Q000627:therapeutic use*; D006801:Humans; D016106:Methicillin Resistance; D055624:Methicillin-Resistant Staphylococcus aureus; D008826:Microbial Sensitivity Tests; D000077266:Moxifloxacin; D009883:Ophthalmic Solutions / Q000627:therapeutic use*; D011804:Quinolines / Q000494:pharmacology / Q000627:therapeutic use; D013203:Staphylococcal Infections / Q000188:drug therapy; D013211:Staphylococcus aureus / Q000187:drug effects; D013296:Streptococcus pneumoniae / Q000187:drug effects; D013535:Suspensions / Q000627:therapeutic use
D000900:Anti-Bacterial Agents; D000935:Antifungal Agents; D001372:Aza Compounds; D001381:Azepines; D024841:Fluoroquinolones; D009883:Ophthalmic Solutions; D011804:Quinolines; D013535:Suspensions; C522124:besifloxacin; D027101:DNA Topoisomerase IV; D027081:DNA Gyrase; D000077266:Moxifloxacin