Levofloxacin 1.5% granted U.S. approval for bacterial corneal ulcer

OSAKA, Japan — U.S. regulators have approved levofloxacin ophthalmic solution 1.5% for the treatment of bacterial corneal ulcer, manufacturer Santen announced yesterday. The drug has been approved for both gram-positive and gram-negative causes of corneal ulcers, the company said.

Iquix (levofloxacin 1.5%) is a sterile topical ophthalmic solution whose “high solubility, at neutral pH, allows the solution to be formulated with a concentration of active drug three times higher than any other ophthalmic fluoroquinolone on the market,” according to company literature.

U.S. regulatory approval was based on data from two randomized, double-masked multicenter trials of 280 patients with positive cultures. Patients were dosed with Iquix or ofloxacin 0.3% ophthalmic solution every 2 hours while awake and 4 and 6 hours after retiring on days 1 through 3. Beginning with day 4, dosing was 4 times daily while awake. Clinical cure was defined as complete re-epithelialization and no progression of the infiltrate for two consecutive visits.

In these trials, Iquix achieved clinical cure rates ranging between 73% and 87%, according to Santen.

The most frequently reported adverse events were headache and a taste disturbance following instillation, which occurred in 8% to 10% of the study participants. Adverse events that occurred in 1% to 2% of the participants included decreased/blurred vision, diarrhea, dyspepsia, fever, infection, instillation site irritation or discomfort, ocular infection, nausea, ocular pain or discomfort and throat irritation. Fewer than 1% of the participants reported chemosis, corneal erosion, corneal ulcer, diplopia, floaters, hyperemia, lid edema and lid erythema.

Santen submitted its data on Iquix to the Food and Drug Administration in April 2003. The company said it expects to launch the drug later this year.