FDA OKs Ista's Bepreve for Allergic Conjunctivitis

Wed, 09/09/2009 - 4:34am
IRVINE, Calif. (AP) — Ista Pharmaceuticals Inc. shares surged late Tuesday after the Food and Drug Administration approved the drugmaker's treatment for itchy eyes in patients with allergic conjunctivitis. The Bepreve eye drops are approved for use by patients ages two years and up. The Irvine, Calif.-based company said late Tuesday it expects to have the drops available in the U.S. in the 2009 fourth quarter, which will boost Ista's full-year revenue above prior expectations. Shares jumped 80 cents, or 14 percent, to $6.50 in electronic trading after the market closed Tuesday. The stock has traded between 29 cents and $6.16 over the past 52 weeks. Allergic conjunctivitis, which differs from viral or bacterial conjunctivitis or 'pink eye,' is an eye allergy linked to exposure to tree pollen, grass and plants, animal dander, feathers, dust mites and molds. "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," said Vicente Anido, Jr., Ista president and CEO, in a statement. "This will allow us not only to finish this year very strongly but also enter next year with an expanded sales force in place." Ista raised its revenue forecast for fiscal 2009 to a range of $104 million to $107 million, from previous guidance of $95 million to $100 million. On average, analysts surveyed by Thomson Reuters forecast sales of $99.8 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," Anido added. The company said approximately 60 million to 90 million Americans suffer from eye allergies. Based on data from IMS Health, in 2008 about 6.6 million prescriptions were filled for eye allergy treatments such as antihistamines and anti-inflammatories, resulting in sales of approximately $560 million.

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