ISTA announces positive phase 2b trial results for ecabet sodium for dry-eye syndrome

By Elaine Rigoli

Tampa, Fla., Feb. 21 - ISTA Pharmaceuticals, Inc. announced Tuesday that its lowest dose of ecabet sodium, a prescription eye drop being evaluated for the treatment of dry-eye syndrome, showed an ability to address corneal staining and blink rate.

In addition, patients treated with the lower dose of ecabet sodium reported positive trends for ocular surface disease index and most bothersome symptom, according to a company news release.

In the preliminary results, no efficacy trends versus a placebo were observed with respect to the higher (3.9%) dose. Further analyses of the phase 2b results are ongoing.

A total of 162 patients were enrolled in the trial and were randomly assigned to receive a placebo, 3.0% or 3.9% ecabet sodium in the study eye four times a day for 90 days.

During the trial, patients were evaluated four times for signs and symptoms, both prior to and following exposure to a dry-eye chamber, a controlled adverse environment.

The trial evaluated ocular signs, including corneal and conjunctival staining; tear film breakup time and blink rate; and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness and blurriness. In addition, the preliminary findings suggest a favorable safety profile, the release stated.

ISTA's phase 2b study was designed to identify the appropriate sign and symptom and time course for future studies. Generally, improvement in one sign and one symptom in phase 3 studies is considered acceptable by the Food and Drug Administration for approval of a prescription dry-eye product, according to the release.

"Our plan is to complete our analyses of these results to confirm our preliminary findings and, in parallel, move quickly into a smaller, short-term confirmatory study designed to further define the subpopulation of patients to enroll and other elements of our phase 3 studies," said Vicente Anido, Jr., PhD, president and chief executive officer, in a company news release.

"Assuming timely and successful completion of this confirmatory study, our plan is to initiate a phase 3 study during 2007."

Based on data compiled from various publicly available sources, ISTA estimates that sales in the U.S. prescription dry-eye market were approximately $200 million in 2005 and are anticipated to grow to approximately $350 to $700 million in annual sales within three to five years.

ISTA is an Irvine, Calif.-based pharmaceutical company focused on the development and commercialization of ophthalmic products to address serious diseases and conditions of the eye, such as dry eye, vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma, pain and inflammation.

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