Bepotastine study’s phase III results encouraging, says ISTA

Irvine, CA-Preliminary analysis of the second-and-final phase III clinical study of bepotastine ophthalmic solution (Bepreve, ISTA Pharmaceuticals) is encouraging, according to the company.

The U.S. multicenter, double-masked, placebo-controlled conjunctival allergen challenge study evaluated the onset and duration of effect of two concentrations of the drug in 130 patients with a history of ocular allergies. Both concentrations reportedly demonstrated highly statistically significant reductions in the primary study endpoint of ocular itching. In addition, both concentrations appear to have produced highly statistically significant effects on the rapidity of response and in the secondary endpoints measuring additional signs and symptoms of ocular allergy, as well as in improvement in total nasal symptoms. There were no serious ocular adverse events reported in the patients receiving the drug.

The phase III study was designed to evaluate the onset and duration of effect of bepotastine in two concentrations and in two dosing schedules, once-daily and twice-daily. Of the 130 patients enrolled, 117 completed the study. Patients were randomly assigned 1:1:1 to receive placebo or one of two concentrations of bepotastine. They were evaluated on three separate visits for their response to the dose administered, to allow for the determination of the time to onset and responses at 8 hours and at 16 hours.

Both statistical significance and degree of clinical response were measured. The strongest clinical effect was achieved with twice-daily dosing of either concentration. Further, the higher concentration of bepotastine demonstrated a once-daily clinical effect that was comparable to the published literature for FDA-approved once-daily ophthalmic solutions studied in patients with ocular allergies.

The recently released data mirror the results from the 107-patient, single-center phase III study of the drug announced in May 2007; that trial used the same study design.

The company is analyzing the results of an ocular safety study in about 850 patients, the preliminary results of which are expected to be released before the end of the second quarter of this year. Once the full dataset is analyzed, the company expects to file a new drug application with the FDA during the second half of the year. The company also plans to discuss the study results with the FDA to determine what, if any, additional information would be required to obtain approval for both a once-daily and twice-daily form of bepotastine.