FDA okays higher-concentration gatifloxacin

Irvine, CA

-Gatifloxacin ophthalmic solution 0.5% (Zymaxid, Allergan) is expected to be available to U.S. physicians and patients this month, according to the manufacturer.

The FDA approved the drug in May for the treatment of bacterial conjunctivitis caused by susceptible strains of

Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis

group,

Streptococcus oralis

, and

Streptococcus pneumoniae

.

The new topical fluoroquinolone anti-infective is the highest-concentration gatifloxacin ophthalmic solution on the market in the United States, according to Allergan. It is formulated with the preservative benzalkonium chloride.

"As pathogens continue to evolve and become more resistant to antibiotics, it is important to develop more potent formulations of anti-infective drugs," said Scott Whitcup, MD, Allergan's executive vice president of research and development and chief scientific officer.

Gatifloxacin 0.5% was assessed in two multicenter, double-masked, randomized dual-arm comparison studies involving 1,437 patients receiving either the solution or vehicle. Efficacy was defined as the complete clearance of conjunctival hyperemia and conjunctival discharge and the eradication of all bacterial species present at baseline.

Results of these studies demonstrated that at day six, complete clearance of conjunctival hyperemia and conjunctival discharge was achieved in 58% of patients (193 of 333) treated with gatifloxacin 0.5% compared with 45% (148 of 325) in the vehicle group, according to Allergan. The solution also demonstrated a statistically superior eradication of bacterial conjunctivitis-approximately 90% (301 of 333) compared with 70% (228 of 325) for vehicle-according to the company.

The recommended dosage is one drop every 2 hours in the affected eye(s) while awake, up to eight times on day one and then two to four times daily while awake on days two through seven.