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Eye Drops Win Unanimous FDA Approval

|Includes: Bausch Health Companies Inc. (BHC)

The pharmaceutical company ISTA Pharmaceuticals (Nasdaq: ISTA) won unanimous support for the approval of their new drug for the treatment of itchy eyes name Bepreve eye drops. The eye drops are designed to treat patients with itchy eyes due to allergies and is for patients ages 2 years and up.  The company’s shares showed the favorable approval jumping as much as 30 percent and hitting a 17 month high of $5.53.

The vote by the Food and Drug Administration was 7-0 due to the fact they  believed that ISTA had proved the effectiveness and safety of Berpreve , along with the fact that the eye medication will be sold by prescription only.

In a statement by executive chairman of Averion International Corp. and panel member Philip Lavin, the studies that Ista provided all delivered the same evidence of effectiveness and safety for the eye drops Bepreve that is due to formally be approved on September 12th.

Frank Pinkerton an analyst for SunTrust Robinson Humphrey has predicted the newly approved eye drops will reach $12 million in sales by 2010.

The side effect evidence that was shown in their latest testing showed about 25 percent of the patients that were being treated with the eye drops is a bitter aftertaste.

The eye drop medication Bepreve will be available to ophthalmologists throughout the United States during the fourth quarter of 2009 according to the President and Chief Executive Officer of ISTA Vicente Anido Jr., Ph.D.