Results are positive from a proof-of-concept phase II clinical study in patients with dry eye disease using a proprietary, low-dose formulation of bromfenac, the active ingredient in bromfenac ophthalmic solution 0.09% (Xibrom, ISTA Pharmaceuticals), the company announced.
-Results are positive from a proof-of-concept phase II clinical study in patients with dry eye disease using a proprietary, low-dose formulation of bromfenac, the active ingredient in bromfenac ophthalmic solution 0.09% (Xibrom, ISTA Pharmaceuticals), the company announced.
Statistical significance was achieved in the primary endpoints of the objective sign of conjunctival staining (lissamine green test) and corneal staining (fluorescein test) as compared with baseline, according to the company. In addition, patients experienced statistically significant improvements in subjective symptoms measured by the Ocular Surface Disease Index and in their most bothersome ocular symptoms.
The study enrolled 38 patients who showed signs and symptoms consistent with moderate dry eye disease. All patients received low-dose bromfenac bilaterally twice a day for 42 days, according to a prepared statement. Prior to the first treatment, patient baseline scores were recorded and then compared with results from day 14, 42, and 52 (10 days post-treatment). Results of the lissamine green test showed statistical significance as early as day 14 and were sustained through day 52. Adverse events were uncommon, and no serious ocular or systemic adverse events were reported.
“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,” said Vicente Anido Jr., PhD, president and chief executive officer of ISTA Pharmaceuticals.
“The results of this study may help identify patients who would be most suitable for a larger, placebo-controlled study,” he continued. “These data come on the heels of our recently announced positive ecabet sodium phase IIb 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.”