Alcon's PATANASE(R) Nasal Spray Approved by FDA for Treatment of Nasal Allerg...( HUENENBERG Switzerland April 15 /...),Health

HUENENBERG, Switzerland, April 15 /PRNewswire-FirstCall/ -- Alcon, Inc. (NYSE: ACL) announced today that the U.S. Food and Drug Administration (FDA) has approved PATANASE(R) (olopatadine hydrochloride) nasal spray for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older. PATANASE(R) nasal spray, an extension to Alcon's market-leading ocular allergy product line, will be available in May of this year.

"We look forward to providing doctors the opportunity to prescribe PATANASE(R) to their patients who need and want a fast-acting nasal spray that quickly relieves symptoms," said Kevin Buehler, Alcon's senior vice president, global markets and chief marketing officer. "We are excited to enter the nasal market and are confident that this new addition will continue to grow our topical allergy franchise."

FDA approval of PATANASE(R) nasal spray was based primarily on multiple clinical studies for the evaluation of safety, efficacy and onset of action. The studies were two-week, randomized, double-blind clinical trials in seasonal allergic rhinitis patients and were conducted to determine the ability of PATANASE(R) to relieve allergy symptoms based on total nasal symptom scores (TNSS, a composite of stuffy, runny, itchy nose and sneezing). The results of these clinical studies were that patients treated with PATANASE(R), two sprays per nostril, twice daily, demonstrated significantly greater decreases in TNSS compared to the placebo nasal spray.

Additionally, onset of action was evaluated in three environmental exposure unit studies. In these studies, patients with seasonal allergic rhinitis were exposed to high levels of pollen and then treated with either PATANASE(R) or placebo nasal
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