Drug news: ISTA / Xibrom phase II results
ISTA Pharmaceuticals Announces Positive Results for Phase 2 Study of Low-Dose Bromfenac in Dry Eye Disease
PR Newswire, June 8
PR Newswire, June 8
IRVINE, Calif., June 8 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced positive results from a proof-of-concept Phase 2 clinical study in subjects with dry eye disease (keratoconjuctivitis sicca) using a new, proprietary, low-dose formulation of bromfenac, the active ingredient in Xibrom(R) (bromfenac ophthalmic solution) 0.09%. 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 also achieved statistical significance on the objective sign of corneal staining (Fluorescein test) as compared to baseline. Patients also achieved statistically significant improvements in subjective symptoms measured by the Ocular Surface Disease Index (OSDI) and improvement in patients' most bothersome ocular symptoms....
ISTA's proof-of-concept, Phase 2 bromfenac study enrolled 38 patients who exhibited signs and symptoms consistent with moderate dry eye disease. All patients received low-dose bromfenac bilaterally twice a day for 42 days. Patient baseline scores were recorded prior to the first treatment with low-dose bromfenac and were compared to baseline at Day 14, Day 42 and Day 52. 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.
Results of the Lissamine Green test in the Phase 2 study revealed statistical significance for low-dose bromfenac versus the patients' baseline scores starting as early as Day 14 and sustained through Day 52, ten days post treatment. Lissamine Green, a validated staining technique that stains the entire ocular surface, allows analysis of dry eye damage on the conjunctiva to determine the severity of dry eye disease. Adverse events were uncommon, and there were no serious ocular or systemic adverse events.