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.