ISTA Pharmaceuticals’ Positive Results For Phase-II Study Of Bromfenac

ISTA has declared positive results for Phase-II clinical study in subjects with dry eye disease (keratoconjuctivitis sicca). The company used its proprietary, low-dose formulation of bromfenac, the active ingredient in Xibrom (bromfenac ophthalmic solution).

The study achieved statistical significance in the primary endpoint of the objective sign of conjunctival staining (Lissamine Green test), as compared to baseline.

The study was designed to investigate the effects of low-dose bromfenac compared to baseline on the objective signs of conjunctival staining (Lissamine Green test) and corneal staining (Fluorescein test), as well as subjective symptoms (OSDI and patient’s most bothersome ocular symptoms), when administered under normal environmental conditions.

Vicente Anido, Jr., President and CEO of ISTA, said: The strong clinical results from this proof-of-concept study further support our belief that a modified, low-dose formulation of bromfenac has the potential ability to effectively and conveniently treat signs and symptoms of dry eye disease and provide fast and sustainable relief for patients. Bromfenac’s strong safety profile should support long-term treatment, which would be necessitated due to the chronic inflammatory nature of dry eye disease.

The results of this study may help identify patients that would be most suitable for a larger, placebo-controlled study. These data come on the heels of our recently announced positive ecabet sodium Phase 2b study results in ISTA’s dry eye franchise. We will analyze the data from both programs to determine which product candidate or candidates to move into further advanced studies, which could begin as early as 2010, he added.