FDA Approves 0.5% Gatifloxacin Eye Drops for Pinkeye

Yael Waknine

May 24, 2010

May 24, 2010 — The US Food and Drug Administration (FDA) has approved gatifloxacin 0.5% ophthalmic solution (Zymaxid; Allergan, Inc) for the treatment of bacterial conjunctivitis caused by susceptible strains of Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, and Streptococcus pneumonia in patients aged 1 year and older.

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.

According to a company news release, the 0.5% gatifloxacin eye drops represent the highest-concentration gatifloxacin ophthalmic solution to be approved by the FDA. The medication will be available in June 2010.

"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, Research and Development, and chief scientific officer, in a company news release. "Allergan has a history of innovation in ocular anti-infective drugs dating back to Ocuflox ophthalmic solution in the early 1990s, and we are pleased to offer a new option to eye care professionals and their patients."

FDA approval was based on data from 2 multicenter, double-masked, randomized dual-arm comparison clinical trials of 1437 patients aged 1 to 89 years, showing that 0.5% gatifloxacin solution was significantly more effective than the nonmedicated vehicle alone for achieving complete clearance of conjunctival hyperaemia and discharge and eradicating all baseline bacterial species by day 6 (58% vs 45%). Microbiologic outcomes also revealed a statistically significant increase in eradication rate for causative pathogens (90% vs 70%).

The recommended dose of gatifloxacin 0.5% ophthalmic solution is 1 drop instilled in the affected eye or eyes every 2 hours while awake on day 1 (up to 8 times), followed by 1 drop instilled 2 to 4 times daily in the affected eye or eyes while awake on days 2 through 7. Contact lenses should not be worn during treatment.

Adverse events most commonly reported in clinical trials (≥1%) included worsening of the conjunctivitis, eye irritation, dysgeusia, and eye pain. Other formulations of gatifloxacin ophthalmic solution have also been associated with chemosis, conjunctival hemorrhage, dry eye, eye discharge, eyelid edema, headache, increased lacrimation, keratitis, papillary conjunctivitis, and reduced visual acuity.

As with other anti-infectives, prolonged use of gatifloxacin may result in overgrowth of nonsusceptible organisms, such as fungi. Alternative therapy should be instituted if superinfection occurs.