FORT WORTH, Texas -- Alcon, Inc. has received approval from the U.S. Food and Drug Administration to market Ciprodex Otic for topical treatment of a middle ear infection known as acute otitis media with tympanostomy tubes (AOMT) in children aged six months and older. The FDA also approved Ciprodex Otic for the topical treatment of acute otitis externa (AOE), a common ear infection also known as swimmer's ear. The AOE indication is for pediatric, adult and elderly patients. Ciprodex Otic is the first-ever topical ear infection treatment that combines the potent antibacterial activity of ciprofloxacin with the anti-inflammatory properties of dexamethasone.
"Targeted topical therapy for ear infections is very effective because higher concentrations of drug can be applied directly to the site of infection," said Peter S. Roland, MD, professor and chairman of otolaryngology-head and neck surgery and professor of neurological surgery, UT Southwestern Medical Center; and chief of pediatric otology, Children's Medical Center of Dallas.
"Inflammation caused by the infection can prevent the drops from reaching the problem area, interfering with the antibacterial action. A steroid can decrease the inflammatory response accompanying the infection. Ciprodex Otic combines the anti-inflammatory agent dexamethasone with the broad spectrum antibiotic ciprofloxacin, resulting in more clinical cures and greater rates of microbiological eradication."
Middle ear infections affect millions of children each year, an illness second only to the common cold. Most cases of middle ear infection occur in children less than three years old, a group in which ear tubes, called tympanostomy tubes, are frequently used to ventilate the middle ear. In the U.S., ear tube insertion is the most-common surgical procedure performed in children, with about two million tubes inserted each year.
"We believe that with this approval, we significantly expand the market opportunity for Alcon," said Mike Hemric, vice president and general manager of pharmaceuticals. "We now have a product that is approved for both AOE and AOMT, and it has been clinically proven to be more effective in treating these infections than leading products on the market today."
Alcon a leading eye care company and has been dedicated to the ophthalmic industry for more than 50 years. Alcon develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens solutions and other vision care products that treat diseases, disorders and other conditions of the eye.
Source: Alcon, Inc.