Alimera Sciences Receives FDA Approval to Market Alaway OTC for Up To 12 Hours of Eye Itch Relief
ATLANTA, December 5, 2006 — Alimera Sciences Inc., an ophthalmic pharmaceutical company founded just three years ago, today announced that the U. S. Food and Drug Administration (FDA) has approved its ophthalmic solution Rx–to-OTC-switch new drug application (NDA) for Alaway (ketotifen fumarate ophthalmic solution 0.025%). Alaway, a multiple action eye anti-allergic, is Alimera’s first NDA submission and the first to win approval. Indicated for the temporary relief of itchy eyes, Alaway will be marketed over-the-counter with the prescription strength active ingredient found in a prescription allergy eye drop.
An estimated 40 million people cope with itchy eyes associated with pollen, ragweed, grass, animal hair and dander – particularly during the spring and fall months. Unlike over-the-counter anti-itch eye drop products currently available, just one dose of Alaway offers eye itch relief within minutes and lasts up to 12 hours. Other over-the-counter products currently available offer no more than four hours of relief and require four doses per day. Alaway, with its unique property of being both an antihistamine and a mast cell stabilizer addresses itchy eyes, the number one complaint among eye allergy sufferers.
“Developing Alaway, submitting the application and achieving FDA approval for a three-year-old company is, indeed, an accomplishment of which Alimera is tremendously proud,” said Dan Myers, president and chief executive officer of Alimera Sciences. “The FDA’s approval of Alaway marks a milestone in Alimera’s overall strategy to consistently deliver innovative solutions to patient needs".
Alimera initially filed the NDA for Alaway in February of this year after completing a successful clinical study that showed it to be bioequivalent to Novartis’ Zaditor (ketotifen fumarate ophthalmic solution 0.025%). Alaway, in a 10mL bottle, is expected to be available to consumers in time to provide prescription strength relief for the spring 2007 allergy season.
Source: Alimera Sciences Inc.
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