According to a government spokeswoman ophthalmic drug maker Ista Pharmaceuticals Inc.'s new drops to treat itchiness in the eye caused by allergies got unanimous support from a U. S. advisory panel on Friday.

The seven members of the Food and Drug Administration's ophthalmic panel unanimously voted in favor of the drug which amounts to a recommendation for approval. A second drug developed by privately held River Plate Biotechnology for treating dry eye was rejected.

The eye drops Bepreve, if granted final approval by the agency would be sold as a prescription drug. Although the FDA is not required to follow the advice of the panel it usually does.

Philip Lavin, executive chairman of Averion International Corp, a clinical research organization and a panel member said, studies by Ista "all deliver the same message and that's in support of safety and effectiveness."

A final decision on Bepreve is expected by Sept. 12, although over the past year the FDA has missed several target dates.

In a statement Ista said, "We believe people who suffer from itchy eyes due to allergies will be pleased to have access to a new therapeutic option" should the drug be cleared for sale. Although there are several medicines approved for treating allergies, Ista said there was a need for new options with fewer side effects as approved drugs could cause sleepiness, dry mouth and other problems.

In Bepreve studies the most frequent side effect seen were changes in taste, such as a bitter taste or after taste reported by 25 % of patients treated with the drug in one study. Ista officials said the drug was safe in people as young as 3 and effects were mild and transient.

The eye-drops Bepreve and an experimental topical steroid for eye infections, called T-Pred, which is also under FDA review, are both vital to Ista's business future. Ista sells the eye drugs Xibrom, Vitrase and Istalol and its net revenue for 2008 was $83 million with a net loss of nearly $31 million.

The company predicts its operating income will roughly break even in 2009. SunTrust Robinson Humphrey analyst Frank Pinkerton has forecast if the drug won approval for U. S. sales Bepreve would see sale of $12 million in 2010. Post the positive recommendation for its Bepreve eye drops, Ista shares went up as much as 30 %, hitting a 17-month high of $5.53 before ending up 43 cents, or 10.14%, at $4.67 on Nasdaq.

The FDA panel voted 6-1 against River Plate's drug and the reviewers said River Plate's application contained major statistical issues surrounding the data on effectiveness. The panel members said findings from two separate studies were not convincing.

Panel member Susan MacDonald, an assistant professor at Tufts University School of Medicine said, "I found the first study to be invalid and in the second the design was flawed."