ISTA Pharmaceuticals, Inc. announced the US Food and Drug Administration (FDA) has approved Bepreve (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.
"Bepreve offers a new, safe and effective way to treat the itching caused by ocular allergies. We expect to have Bepreve available to ophthalmologists and patients in the United States in the fourth quarter of 2009," stated Vicente Anido, Jr., Ph.D., president and chief executive officer of ISTA. "Because of the timing of this approval and the strength of our underlying business, we will accelerate all of the launch activities immediately, including the scale-up of the sales force. This will allow us not only to finish this year very strongly but also enter next year with an expanded sales force in place. Bepreve and Xibrom will share the top spot on our promotional activities, but we will continue to devote time and energy to Istalol, too."
ISTA conducted multiple clinical studies, evaluating the safety, efficacy, onset and duration of effect of Bepreve. Two phase 3 double-masked, placebo-controlled, conjunctival allergen challenge (CAC) studies demonstrated Bepreve significantly reduced ocular itching. In addition, the studies achieved statistical significance and demonstrated Bepreve's rapid onset of action in providing relief to persons with ocular itching associated with allergic conjunctivitis.
"Patients who experience ocular itching due to allergies want comfortable, quick and long-lasting relief for their eyes. Bepreve is the first truly new treatment for allergic conjunctivitis approved in several years. Allergic conjunctivitis, not to be confused with viral or bacterial conjunctivitis or pink eye, is an eye allergy that often results in ocular itching, and I am excited patients will have this new treatment option," commented Gregg J. Berdy, M.D., Assistant Professor of Clinical Ophthalmology, Washington University School of Medicine.
Dr. Anido concluded, "As we are accelerating our launch timing to the fourth quarter and are expanding our sales force, we now expect to be able to recognize Bepreve revenue this year. In addition, Xibrom and Istalol are performing particularly well year to date, giving us confidence to increase our full-year 2009 net product revenue guidance for our four marketed products to $101 million to $104 million. Our total net revenue for full-year 2009, including net product revenue and $2.9 million from the one-time recognition of deferred revenue resulting from our previously disclosed modification of our partnership with Otsuka, is now expected to be $104 million to $107 million. We also are reiterating our guidance that ISTA will be operating income neutral in 2009, as our increased net revenue will offset the costs associated with launching Bepreve and expanding our sales force."
Approximately 60 to 90 million Americans suffer from ocular allergy. Allergic conjunctivitis, the most common allergy affecting the eyes, is caused by exposure to certain allergens such as pollen from trees, grass and plants, animal dander, feathers, dust mites and molds. Ocular itching is the most common symptom of ocular allergy, reported by more than 75% of allergy patients. Current treatments for allergic conjunctivitis include antihistamines, mast cell stabilizers and anti-inflammatories. Based on data from IMS Health, in 2008 approximately 6.6 million prescriptions were filled for ocular allergy treatments, resulting in sales of approximately $560 million.
Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues. The compound's primary mechanisms of action are believed to make it an effective treatment against ocular itching associated with allergic conjunctivitis.
Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name Talion. Talion was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine. In 2001, Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine for ophthalmic use. In 2006, ISTA licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis. In 2007, ISTA licensed exclusive North American rights to nasal dosage forms of bepotastine from Tanabe Seiyaku and obtained a future right to negotiate for a North American license to oral dosage forms of bepotastine for allergy treatment.