Alimera Sciences Receives FDA Approval To Market Alaway(TM) OTC For Up To 12 Hours Of Eye Itch Relief

Main Category: Eye Health / Blindness
Also Included In: Allergy
Article Date: 06 Dec 2006 - 0:00 PDT

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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(TM) (ketotifen fumarate ophthalmic solution 0.025%). Alaway(TM), 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(TM) 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(TM) 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(TM), 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(TM), 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(TM) marks a milestone in Alimera's overall strategy to consistently deliver innovative solutions to patient needs.

Alimera initially filed the NDA for Alaway(TM) in February of this year after completing a successful clinical study that showed it to be bioequivalent to Novartis' Zaditor(R) (ketotifen fumarate ophthalmic solution 0.025%). Alaway(TM), in a 10mL bottle, is expected to be available to consumers in time to provide prescription strength relief for the spring 2007 allergy season.

About Alimera Sciences Inc.

Alimera Sciences Inc., a venture backed company, specializes in the development and commercialization of over-the-counter and prescription ophthalmology pharmaceuticals. Founded by an executive team with extensive development and revenue growth expertise, Alimera Sciences' products address both the anterior (front) and posterior (back) segments of the eye. In August 2004, Alimera Sciences unveiled Soothe(R), the market's first multi-dose, emollient-based artificial tear product, and in October 2005 initiated a Phase III clinical trial to study diabetic macular edema (DME) patients treated using Medidur(TM) with fluocinolone acetonide, the company's pharmacologic treatment for DME.

Alimera Sciences Inc.
http://www.alimerasciences.com