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FDA Approves Prescription Zaditor (ketotifen fumarate) Eye Drops for Over-the-Counter Relief From Itchy Eyes

* Zaditor Provides Up to 12 Hours of Continuous Itch Relief With One Drop

* Only Non-Prescription Medication to Relieve Eye Itch Without a Decongestant

* First Over-The-Counter Eye Itch Relief Drop Safe for Children as Young as Three

FLORHAM PARK, NJ -- October 20, 2006 -- Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved prescription Zaditor(R) (ketotifen fumarate ophthalmic solution 0.025%), indicated for the temporary prevention of itchy eyes due to allergic conjunctivitis, for OTC use.

An estimated 40 million Americans suffer from eye allergies. Whether in reaction to seasonal allergens including pollen and ragweed, or perennial allergens such as animal hair or pet dander, itchy eyes are a main complaint.

While most OTC products provide only 3-4 hours of short-term relief, Zaditor's full prescription strength formula offers eye itch relief that works in minutes and lasts up to 12 hours with just one drop. This significantly reduces the number of doses required per day to keep affected eyes itch-free. In addition, Zaditor is the first OTC eye itch medication safe for use in children as young as three.

"Now for the first time, people who suffer from itchy eyes caused by allergens such as pollen or pet dander can get fast, long-acting relief over- the-counter with Zaditor," says Marion Morton, Head of the US Novartis Ophthalmics Business Unit. "Because Zaditor is now available at full prescription strength without a prescription, consumers can save time and money without sacrificing long-lasting symptom relief."

Zaditor is 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. Many OTC eye drops contain topical decongestants, which constrict the blood vessels to reduce the appearance of redness in the eye. With regular use, these products 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 (rebound effect). Zaditor does not contain a decongestant and may be used without risk of rebound redness.

"The availability of Zaditor without a prescription greatly improves treatment options for eye itch sufferers," said Jane MacEnroe, MD, Associate Director, Medical Information and Communication, 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."

Triple Mechanism of Action
Zaditor is the only OTC eye itch drop with a triple-action formula to provide fast, durable efficacy at the source. It includes a:

* Potent antihistamine that rapidly relieves itchy eyes within minutes

* Mast cell stabilizer that provides extended relief for up to 12 hours

* Prevents the release of chemical mediators to stop the late phase allergic reaction

Histamines, a chemical made by the body during an allergic reaction, are a primary cause of itchy eyes. Unlike most OTC drops, Zaditor blocks the histamines that cause itchy eyes and prevents the release of additional histamines, treating the source of the itch, not just the symptoms.

Approved in 1999 for prescription use, Zaditor has become a leading treatment for the temporary prevention of itchy eyes due to allergic conjunctivitis. Zaditor will be available over-the-counter in drug and chain stores nationwide beginning January 2007. It has a suggested retail price of $14.99 for a 30-day supply. In clinical studies, Zaditor was well tolerated and any side effects are generally mild.


SOURCE: Novartis Ophthalmics

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