FDA Approves Besifloxacin for Bacterial Conjunctivitis

Yael Waknine

June 03, 2009

June 3, 2009 — The US Food and Drug Administration (FDA) has approved besifloxacin 0.6% ophthalmic suspension (Besivance, Bausch & Lomb, Inc [copromoted with Pfizer, Inc]) for the treatment of bacterial conjunctivitis caused by susceptible isolates of CDC coryneform group G, Corynebacterium pseudodiphtheriticum, Corynebacterium striatum, Haemophilus influenza, Moraxella lacunata, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus lugdunensis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumonia, and Streptococcus salivarius bacteria.

Also known as pinkeye, bacterial conjunctivitis is a contagious condition marked by eye irritation and mucus membrane discharge. Left untreated, the infection usually runs its course in 1 to 2 weeks.

"Bacterial conjunctivitis is a common condition that affects people of all ages," said Wiley A. Chambers, MD, in an agency news release. "It is important to have a variety of treatment options available to health care professionals and patients because an effective drug therapy can reduce the duration of the illness and reduce the chances of infecting others."

Dr. Chambers is acting director of the Division of Anti-Infective and Ophthalmology Products in the FDA's Center for Drug Evaluation and Research.

Approval of the topical fluoroquinolone was based primarily on data from a randomized, double-blind, multicenter clinical trial of patients aged 1 to 98 years, showing that use of besifloxacin was significantly more effective for achieving clinical resolution of bacterial conjunctivitis symptoms than the nonmedicated vehicle alone (45% vs 33%; 95% confidence interval, 3% – 22%). Microbiologic outcomes also revealed a statistically significant increase in eradication rate for causative pathogens (91% vs 60%).

According to the FDA, patients receiving the active formulation demonstrated a faster resolution rate compared with patients receiving the vehicle alone.

Adverse events reported in less than 3% of clinical trial patients included conjunctival redness, blurred vision, eye pain, irritation and itching, and headache.

The recommended dose regimen for besifloxacin is 1 drop instilled in the affected eye 3 times daily (4 – 12 hours apart) for 7 days. Wearing of contact lenses should be avoided during treatment.

Patients should be informed that skipping doses or not completing the full course of therapy may decrease the efficacy of current treatment and increase the likelihood for bacterial resistance in the future.

Although besifloxacin is for topical use only, systemically administered quinolones have been linked to a risk for hypersensitivity reactions after just 1 dose. Patients should be advised to discontinue use immediately and contact their clinician at the first sign of rash or allergic reaction.

Full Prescribing Information