The US multi-center conjunctival allergen challenge study evaluated the onset and duration of effect of two Bepreve concentrations in 130 patients with a history of ocular allergies. Both concentrations demonstrated highly statistically significant reductions in the primary study endpoint of ocular itching.
The strongest clinical effect achieved was with twice-daily dosing of either concentration. Further, the higher concentration of Bepreve 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.
In addition, both concentrations 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 improvement in total nasal symptoms. There were no serious ocular adverse events reported in patients dosed with Bepreve.
Ista currently is analyzing the results of an ocular safety study in approximately 850 patients, with preliminary results anticipated before the end of the second quarter of 2008. Once the company completes its analysis of the full dataset, Ista expects to file a new drug application with the FDA during the second half of 2008.