Ista Pharmaceuticals Files for IPO With SEC

Ista Pharmaceuticals Inc., an Irvine company that is developing treatments for eye afflictions, filed to raise as much as $86.25 million in an initial stock sale.

The company’s lead product candidate, Vitrase, is supposed to treat vitreous hemorrhage and diabetic retinopathy, the company said in a filing with the Securities and Exchange Commission.

Vitreous hemorrhage, a sight-threatening condition, occurs when blood vessels in the eye’s retina rupture and bleed into the “vitreous humor�--the clear, gel-like substance that fills the back of the eye between the lens and the retina.

Diabetic retinopathy, the leading cause of adult blindness in the U.S., results from abnormal changes to blood vessels in the eye that are triggered by diabetes.

Vitrase is in the third phase of clinical testing that the Food and Drug Administration requires before it will review its safety and effectiveness at treating vitreous hemorrhage, the filing said. The product is in a pilot, second-stage clinical trial for treating diabetic retinopathy.

Vitrase is a proprietary formulation of a naturally occurring enzyme that, when injected into the vitreous humor, causes it to liquefy. This helps to clear hemorrhages, the filing said.

The only other known options for dealing with vitreous hemorrhage are to wait and hope it clears up on its own or to have surgery to remove the blood-filled vitreous humor from the eye, the filing said.

When injected into an eye afflicted with diabetic retinopathy, Vitrase separates the vitreous humor from the retina, limiting the growth of abnormal blood vessels in the back of the eye, the company said.

The product has received a “fast-track� designation by the FDA, which usually, but not always, means that the agency will spend less time considering whether to approve the drug. The agency bestows the designation on products that appear to offer a significant benefit over other therapies.

The company last month bought Visionex Ltd., a Singapore corporation that was related to Ista through common ownership by some of Ista’s stockholders, the filing said. Visionex is testing Vitrase in Singapore.

Ista’s backers include Allergan Inc., a Irvine-based producer of eye-care and specialty pharmaceutical products that has invested $10 million in the company.

Allergan has agreed to market Vitrase until April 2004 in all markets except Mexico, the filing said. Allergan will split profit with Ista from U.S. sales and pay Ista a royalty on any international sales.

The family of Gordon Gund, owner of the Cleveland Cavaliers National basketball Association team, has also invested, the filing said. Gund, who is visually impaired, chairs The Foundation Fighting Blindness.