Phase II/III trial of bepotastine shows promise against ocular itching

Irvine, CA-Preliminary phase II/III results of a clinical trial of bepotastine for the treatment of allergic conjunctivitis show statistically significant results against some symptoms, according to ISTA Pharmaceuticals Inc.

The study evaluated two concentrations of bepotastine, each given once or twice daily, for their efficacy against ocular itching and redness. Both concentrations showed effectiveness against ocular itching at highly statistically significant levels when given twice a day, according to preliminary results, and one concentration showed efficacy with once-a-day dosing.

Both concentrations and dosing regimens also produced highly statistically significant differences in the rapidity of response and the improvement in total nasal symptoms versus placebo. Against ocular redness, however, bepotastine showed a trend toward clinical significance but did not achieve statistical significance, according to the company.

No serious adverse events, incidences of burning or stinging with either concentration, or increases in ocular adverse events compared with placebo were reported.

ISTA Pharmaceuticals plans to finish analyzing the study and then discuss the results with the FDA to determine the remaining clinical studies needed to submit a new drug application (NDA).

In other news, ISTA Pharmaceuticals announced that the FDA did not approve its NDA for prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension (T-Pred). The company is developing the topical steroid formulation to treat inflammatory ocular conditions for which corticosteroids are indicated and where bacterial ocular infections or a risk of bacterial infections exists.

ISTA Pharmaceuticals completed its phase III clinical study of the formulation in late 2005. The company designed the multicenter, randomized, double-blind study to determine the bioequivalence of its formulation and a proprietary formulation of prednisolone acetate 1.0% (PredForte, Allergen).

“We believe our clinical study met the endpoints that ISTA [Pharmaceuticals] and the FDA agreed to in the special protocol assessment. Nonetheless, the FDA did not find sufficient clinical information to merit approval,” said Vicente Anido Jr., PhD, ISTA Pharmaceuticals president and chief executive officer.

The company will continue to work with the FDA in an effort to bring the product to market, he added.