ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced the U.S. Food and Drug Administration (FDA) has approved Bepreve(TM) (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."