Tuesday, ISTA Pharmaceuticals, Inc. (ISTA) announced that its drug candidate to treat ocular itching associated with allergic conjunctivitis in patients two years of age and older, Bepreve, received approval from the U.S. Food and Drug Administration or FDA. The drug is twice-daily prescription eye drop.
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 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.
Commenting on the advance launching of products, ISTA's president and chief executive officer, Vicente Anido said, "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."
In addition, the company said its two other drugs, Bepreve and Xibrom will share the top spot on its promotional activities. The company also plans to continue to devote time and energy to Istalol.
As a result of these sales promotional activities, the company increased its full-year 2009 net product revenue guidance for its four marketed products to the range of $101 million to $104 million.
Further, the company said it now expects its total net revenue for full year 2009 to be $104 million to $107 million, compared to its prior guidance of $92 million to $97 million. Analysts polled by Thomson Reuters currently expect the company to report revenue of $99.80 for the full year 2009.
In a separate press release, ISTA revealed preliminary results from two recently completed studies on its investigational ophthalmic product, T-Pred, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension. The company is developing T-Pred as a treatment for inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infection exists, or there is a risk of bacterial infection.
ISTA closed Tuesday's regular trading at $5.70, down $0.30 or 5.00% on a volume of 350,055 shares. However, the stock gained $0.80 or 14.04% in the after-hour trade.
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