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1. Ista Pharmaceuticals Inc.

Ista Pharmaceuticals Inc. has bragging rights as Orange County’s fastest-growing public company by revenue.

The Irvine-based eye drug maker posted 1,228% revenue growth for the three years ended June 30. Sales have grown from $400,000 for the 12-month period through June 2002 to $5.3 million in the period ended June 30 of this year.

Ista’s sales gain has been fueled by the commercialization of its first two products, Istalol and Vitrase, both of which have launched during the past two years.

Ista replaced former champ Cardiac Science Inc. at the top of the list. Cardiac Science, a maker of heart defibrillation devices, moved from Irvine to suburban Seattle during the past year after combining with Quinton Cardiology Systems Inc.

Although Ista’s sales have surged during the past three years, it hasn’t been all good news of late for the drug maker.

For the first six months of this year, Ista posted a net loss of $18.6 million, compared to a loss of $13.6 million for the same period in 2004.

And Ista shares fell near a 52-week low of $5.80 last week. In September, RBC Capital Markets dropped its rating on the company’s shares, citing lower-than-expected sales of Xibrom, a drug used to prevent eye inflammation after cataract surgery.

RBC downgraded Ista to “underperform” from “sector perform,” less than two months after the brokerage cut the stock from an “outperform” ranking.

RBC, in a report, mentioned concerns that Xibrom, which was approved in March and launched during the summer, wasn’t selling as strongly as expected and faces competition.

Xibrom, accounted for $1.9 million of Ista’s $2.7 million worth of net product sales in the second quarter.

Analyst Douglas Miehm lowered his target price for the drug maker to $6 from $9, and said that Xibrom would have to capture 20% of the market for non-steroidal anti-inflammatory drug market to meet his original forecast of $23.9 million in sales for 2006.

Miehm also was concerned about a competing drug for Xibrom called Nevanac, which is produced by Alcon Inc., a Nestl & #233; SA unit that employs about 500 people in Irvine.

Nevanac received FDA approval in August.

Ista is set to report its third-quarter financial results Nov. 8. The company’s shares have bounced between $5.56 and $11.80 during the past year. The company has a market value of about $150 million at recent check.

Ista focuses on several types of eye drugs. Its first product to be commercialized is Istalol, a one-dose-a-day eye drop medication to treat glaucoma, a chronic disease that’s characterized by elevated pressure within the eye and is a leading cause of blindness.

Senju Pharmaceutical Co. of Japan developed Istalol, which Ista acquired marketing rights to in 2002.

Ista received Food and Drug clearance for Istalol in June 2004, and launched it in last year’s third quarter.

Meanwhile, Ista also has launched Vitrase, another key product. Vitrase is a spreading agent for other drugs, and is awaiting regulatory word about its use for a separate application,treating vitreous hemorrhage, or back-of-the-eye bleeding.

In the pipeline, Ista is working on ecabet sodium as an eye drop to treat dry eye syndrome.

Ista acquired domestic marketing rights to ecabet sodium through a license agreement with Senju signed last November.

The company also is working on Caprogel, a treatment for bleeding in the space between the cornea and the iris of the eye.

Ista, like other developing companies in the OC eye drug and device industry, has some ties to Allergan Inc. The Irvine drug maker derives much of its revenue from ophthalmic drugs and is considered a seminal company in the industry here.

Ista Chief Executive Vicente Anido worked as president of Allergan’s Americas region from 1993 to 1996.

Other Ista executives with Allergan backgrounds include Chief Financial Officer Lauren Silvernail, Kirk McMullin, vice president of operations and Thomas Mitro, vice president of sales and marketing.

Ista has 74 workers in OC and 160 in all. The company was founded in 1992 as Advanced Corneal Systems Inc., and changed its name to Ista in 2000.

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