Phase III studies of lower-concentration bromfenac begin

Irvine, CA-ISTA Pharmaceuticals Inc. has started phase III clinical trials to study the safety and efficacy of its proprietary formulation bromfenac ophthalmic solution (Remura) for the alleviation of signs and symptoms of dry eye disease under a special protocol assessment (SPA) agreed on with the FDA.

“Reaching agreement with the FDA on the SPA for [bromfenac] efficacy studies provides additional clarity regarding the path to approval, which will help us to bring a safe and effective treatment to patients suffering from dry eye,” said Vicente Anido Jr., PhD, president and chief executive officer of ISTA.

The program will include four multicenter, randomized, double-masked, placebo-controlled studies. The ophthalmic solution will be evaluated in two simultaneous studies operating under a common protocol in about 1,000 patients with mild or moderate dry eye disease at more than 30 sites in the United States. Two concentrations of bromfenac (both lower than the currently marketed bromfenac 0.09% [Xibrom]), will be dosed in addition to placebo. Patients will be randomly assigned at a ratio of 1:1:1 to receive either bromfenac or placebo in both eyes twice daily and will be evaluated over 42 days. For both efficacy studies, the objective sign of conjunctival staining will be measured using the lissamine green test, and subjective symptoms will be measured using the Ocular Surface Disease Index (OSDI). ISTA anticipates reporting results in the middle of next year.

The two remaining phase III safety studies are the subject of additional SPAs currently under review by the FDA. To meet FDA guidance on drugs for chronic dosing, the company expects to conduct both a 6- and a 12-month safety study. ISTA anticipates it will start one or both of these safety studies later this year, subject to reaching agreement with the FDA on the SPAs.