Akorn, Inc. (NASDAQ: AKRX) today announced the commercial launch of Akten(TM) Gel 3.5%, a topical ocular anesthetic ophthalmic drug product. Akten(TM) represents the first FDA approved drug product indicated for use as an ocular anesthetic in four decades. Akten(TM) is the only approved ocular gel formulation that also contains the highest concentration of lidocaine. Akten(TM) has several unique features: it is preservative free, non toxic to the cornea, does not sting due to its physiological pH and can be stored at room temperature. Akten(TM) can be used as a local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures. Examples of these procedures include cataract/glaucoma surgery, intravitreal injections for retinal disorders, retina surgery, and miscellaneous ocular procedures both in hospital/clinics and office based practices.
The results of a phase III clinical trial for Akten(TM) have been published as a manuscript in a peer reviewed journal, Ophthalmic Surgery, Lasers & Imaging (OSLI); September/October 2008, “Lidocaine Hydrochloride Gel For Ocular Anesthesia: Results of a Prospective Randomized Study.” The study findings include safety, efficacy and tolerability of Akten(TM), and will be presented by Drs. B. Busbee, A. Alam and E. Reichel at the upcoming American Academy of Ophthalmology (AAO) meeting in Atlanta on November 8 and 9, 2008 at the Akorn booth #3421.
Akten(TM) will be marketed by Akorn’s 65 member sales team, who will detail ophthalmologists located in hospitals, surgery centers and private physician offices. An advertising awareness campaign is planned to launch Akten(TM). The initial marketing packet including an introduction letter, product details and benefits, package insert, an invitation to AAO and a copy of the OSLI clinical paper will be mailed to every ophthalmologist in the U.S. Akten(TM) will be prominently displayed monthly in EyeNet Magazine, the official journal of AAO. Akorn will also launch a detailed Akten(TM) website, www.akorn.com/akten, where physicians can become further educated on the product and order Akten(TM) online.
Arthur S. Przybyl, Akorn’s President and Chief Executive Officer stated, “I believe that Akten(TM) will become the standard of care whenever an ocular anesthetic is required. Akten(TM) represents a new horizon in ocular anesthesia. The benefits of Akten(TM) are important to consider whenever an ocular procedure is necessary.”
About Akorn, Inc.
Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company’s website at www.akorn.com.
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