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Vigamox gains U.S. approval
SAN FRANCISCO — U.S. regulators have granted marketing approval for moxifloxacin ophthalmic solution 0.5%, a fluoroquinolone, after a 6-month review, Alcon announced here during the American Society of Cataract and Refractive Surgery meeting.
Vigamox, as the ophthalmic solution will be known, gained approval for use in adults and children as young as 1 year for the treatment of bacterial conjunctivitis. According to an Alcon press release, the solution is highly soluble, allowing it to be formulated at high concentrations.
Clinical trials showed Vigamox to be effective in the treatment of gram-positive bacteria, including Staphylococcus and Streptococcus. It is also highly active against Chlamydia, according to Alcon.
The Food and Drug Administration granted its approval based on data from three clinical trials involving more than 1,400 patients. The antibiotic’s preferred dosing regimen is three times daily for 7 days. Alcon expects to begin shipping Vigamox within the next few weeks.
The approval of Vigamox follows by just over 2 weeks the approval of another fourth-generation fluoroquinolone, Zymar (gatifloxacin ophthalmic solution 0.3%, Allergan). For more on that approval, click here.