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The Food and Drug Administration has approved an ophthalmic formulation of a fluoroquinolone antibiotic, besifloxacin, for the treatment of bacterial conjunctivitis.
Besifloxacin ophthalmic suspension will be marketed as Besivance 0.6%, by Bausch & Lomb Inc. The recommended dosage is one drop in the affected eye or eyes three times a day, 4–12 hours apart for 7 days. The prescribing information summarizes a randomized study of almost 400 patients (aged 1–98 years) with bacterial conjunctivitis who were treated with besifloxacin or received placebo drops for 5 days. Clinical symptoms resolved in 45% of those on besifloxacin, compared with 33% of those on the vehicle. The eradication rate for causative pathogens in the besifloxacin group was statistically significant at 91%, compared with 60% in the vehicle group.
The most commonly reported ocular adverse event reported in treated patients has been conjunctival redness in about 2% of patients. To collect more safety data on besifloxacin, the FDA is requiring that the company conduct a postmarketing study comparing the recommended dosage of besifloxacin to vehicle in at least 300 patients with signs and symptoms of bacterial conjunctivitis.
The Food and Drug Administration has approved an ophthalmic formulation of a fluoroquinolone antibiotic, besifloxacin, for the treatment of bacterial conjunctivitis.
Besifloxacin ophthalmic suspension will be marketed as Besivance 0.6%, by Bausch & Lomb Inc. The recommended dosage is one drop in the affected eye or eyes three times a day, 4–12 hours apart for 7 days. The prescribing information summarizes a randomized study of almost 400 patients (aged 1–98 years) with bacterial conjunctivitis who were treated with besifloxacin or received placebo drops for 5 days. Clinical symptoms resolved in 45% of those on besifloxacin, compared with 33% of those on the vehicle. The eradication rate for causative pathogens in the besifloxacin group was statistically significant at 91%, compared with 60% in the vehicle group.
The most commonly reported ocular adverse event reported in treated patients has been conjunctival redness in about 2% of patients. To collect more safety data on besifloxacin, the FDA is requiring that the company conduct a postmarketing study comparing the recommended dosage of besifloxacin to vehicle in at least 300 patients with signs and symptoms of bacterial conjunctivitis.
The Food and Drug Administration has approved an ophthalmic formulation of a fluoroquinolone antibiotic, besifloxacin, for the treatment of bacterial conjunctivitis.
Besifloxacin ophthalmic suspension will be marketed as Besivance 0.6%, by Bausch & Lomb Inc. The recommended dosage is one drop in the affected eye or eyes three times a day, 4–12 hours apart for 7 days. The prescribing information summarizes a randomized study of almost 400 patients (aged 1–98 years) with bacterial conjunctivitis who were treated with besifloxacin or received placebo drops for 5 days. Clinical symptoms resolved in 45% of those on besifloxacin, compared with 33% of those on the vehicle. The eradication rate for causative pathogens in the besifloxacin group was statistically significant at 91%, compared with 60% in the vehicle group.
The most commonly reported ocular adverse event reported in treated patients has been conjunctival redness in about 2% of patients. To collect more safety data on besifloxacin, the FDA is requiring that the company conduct a postmarketing study comparing the recommended dosage of besifloxacin to vehicle in at least 300 patients with signs and symptoms of bacterial conjunctivitis.