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1. ISTA PHARMACEUTICALS INC.

A head-spinning sales explosion has returned Ista Pharmaceuticals Inc. to the top of Orange County’s fastest-growing public companies.

Ista, an Irvine-based eye drug maker, saw its revenue grow 11,080% during the three years ended June 30. The company’s sales have grown from $400,000 for the 12 months ended June 2004 to $44.7 million through June of this year.

Ista’s sales have grown because three drugs,Istalol, Vitrase and Xibrom,have come to market or were in early release during the past three years.

Ista dethroned last year’s No. 1 Newport Beach-based Acacia Research Corp., which buys patents and collects licensing fees from companies. Acacia is No. 2 on this year’s list.

Two years ago, Ista rose to the top of the list, replacing former champ Cardiac Science Inc., a maker of heart defibrillation devices that moved its headquarters from Irvine to the Seattle area after combining with Quinton Cardiology Systems Inc.

Ista’s second-quarter sales surged to $13.6 million, a 92% hike from $7.1 million a year earlier.

“The sales growth exhibited by our products outpaced the growth of the markets in which they compete, and so obviously we’re gaining share over our competitors,” said Chief Executive Vince Anido during a recent conference call.

Prescriptions for Xibrom, Ista’s flagship drug for treating pain after cataract surgery, were up 125%, he said.

But Ista’s sales surge hasn’t necessarily translated into profits.

In the second quarter, Ista said its net loss narrowed to $8.7 million from $9.5 million a year earlier.

And Ista’s shares, which had been up as high as nearly 50% earlier this year, took a big hit in May, after the Food and Drug Administration sent the company a “not approvable” letter for T-Pred, a steroid it is developing to treat eye inflammation. Shares fell 41% on the news.

Ista said it disagreed with the FDA’s decision and would request a meeting to discuss the issue.

Shares now are off about 3% for the year with a recent market value of $220 million.

Besides Xibrom, Ista’s roster includes several drugs.

Istalol, a one-dose-a-day eye drop medication to treat glaucoma, was its first commercialized product.

Glaucoma, a chronic condition of elevated pressure within the eye, is a leading cause of blindness.

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

Ista got regulatory clearance for Istalol in 2004 and launched it in 2005.

Ista then moved to Vitrase, another key product, which serves as a spreading agent for other eye drugs. Ista is awaiting regulatory clearance for Vitrase as a treatment for vitreous hemorrhage, or back-of-the-eye bleeding.

In its pipeline, the company is working on ecabet sodium as an eye drop for treating dry eyes.

Ista got domestic marketing rights to ecabet sodium through a license agreement with Senju signed in 2004.

Caprogel, which treats bleeding in the space between the cornea and iris, is also part of Ista’s pipeline.

Last month, Ista made a potential move away from the eyes, when it spent $2 million for marketing and development rights for a nasal version of bepotastine, an allergy medication.

Like other emerging companies in Orange County’s eye drug and device industry, Ista has links to Irvine-based Allergan Inc.

Anido, Ista’s president and chief executive, was president of Allergan’s Americas region from 1993 to 1996.

Lauren Silvernail, chief financial officer, Kirk McMullin, vice president of operations, and Thomas Mitro, vice president of sales and marketing, are other Ista executives with Allergan backgrounds.

Ista has 106 OC workers and 213 in all. It was founded 15 years ago as Advanced Corneal Systems Inc. and changed its name to Ista in 2000.


THE NUMBERS

Three-year growth: 11,080%

Yearly sales through June 30: $44.7 million

Yearly loss: $38.1 million

Market value: $220 million

Employees: 213, 106 in OC

Company: eye drug developer

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