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:Alcon's Newest Antibiotic, Vigamox Ophthalmic Solution, Earns FDA Approval
FORT WORTH, Texas, April 16 /PRNewswire-FirstCall/ -- Alcon, Inc. announces that it received approval from the U.S. Food and Drug Administration (FDA) of its newest antibiotic product, Vigamox (moxifloxacin ophthalmic solution) 0.5 percent, after a six-month review. Vigamox solution contains moxifloxacin, a potent fourth-generation fluoroquinolone antibiotic and is safe and effective for adults and children as young as one year old.
Vigamox solution, dosed only three times a day for seven days, treats bacterial conjunctivitis. Alcon has studied Vigamox solution extensively in three major clinical trials involving more than 1,400 patients.
Moxifloxacin is highly soluble, which allows it to be formulated at a higher concentration (0.5 percent) than other fourth-generation fluoroquinolones. It is very effective against many types of harmful bacteria that infect the surface of the eye. Vigamox solution also shows enhanced coverage of difficult-to-treat Gram-positive bacteria, a class including Staphylococcus and Streptococcus, which account for an estimated 80 percent of eye infections. It is also highly active against Chlamydia, as well as other emerging bacterial threats.
In addition to its therapeutic benefits, Vigamox solution is robust enough to be formulated without the preservative benzalkonium chloride, as a result of the inherent antimicrobial activity of moxifloxacin. It also has a near-neutral pH, resulting in a low incidence of stinging when applied in the eye -- an especially important consideration for children. Furthermore, Vigamox solution provides excellent penetration into ocular tissues. Alcon expects Vigamox solution to be available within several weeks.
Source: Alcon, Inc.