Pharmaceutical Business review

FDA approves Zaditor for OTC use

The approval makes Zaditor the only OTC drop to treat eye itch associated with pollen, ragweed, grass, animal hair and dander without the potentially negative effects of a decongestant. Eye drops with decongestants can interfere with the eye’s natural ability to regulate the blood vessels, resulting in a continued redness for a period of time after discontinuation.

In addition, while most OTC products provide only three to four hours of short-term relief, Zaditor lasts up to 12 hours with just one drop and is safe for use in children as young as three. An estimated 40 million Americans suffer from eye allergies.

“The availability of Zaditor without a prescription greatly improves treatment options for eye itch sufferers,” said Jane MacEnroe, associate director of medical information and communication for Novartis Ophthalmics. “For the first time, patients can get lasting relief over-the-counter without worrying about potential side-effects associated with long-term use of topical decongestants found in other OTC eye itch drops.”