ISTA Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products, announced that the company is initiating two randomized, double-blind, placebo-controlled multi-centre phase III clinical trials of a new proprietary once-daily formulation of Xibrom (bromfenac ophthalmic solution) for the treatment of pain and inflammation following cataract surgery. Twice-daily Xibrom has been approved by the US Food and Drug Administration for the treatment of ocular inflammation and reduction of ocular pain following cataract surgery.
The Xibrom once-daily phase III clinical trials, which are expected to enrol approximately 350 patients under a common protocol, are designed to investigate the safety, tolerability and efficacy of once-daily Xibrom for the treatment of post-operative ocular pain and inflammation in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation. ISTA believes that the clinical trials will be concluded in the fourth quarter of this year with preliminary results available in early 2007. Assuming timely completion and successful results of the phase III clinical studies, ISTA intends to file a supplemental New Drug Application for the once-daily formulation of Xibrom in 2007.
"These phase III studies of a once-daily formulation are a natural extension of ISTA's continued research with Xibrom," stated Vicente Anido, Jr., Ph.D., president and chief executive officer of ISTA Pharmaceuticals. "The trials we are now initiating are designed to demonstrate that once-daily application of our new proprietary formulation of Xibrom can further reduce the number of daily doses, potentially improving compliance while maintaining effectiveness."
Xibrom (bromfenac ophthalmic solution) 0.09 per cent is a sterile, topical, non-steroidal anti-inflammatory solution for the treatment of ocular inflammation and pain following cataract surgery. Senju Pharmaceuticals Co. Ltd. has marketed the twice-daily formulation of this product in Japan since 2000 with over 7.9 million uses since that time. ISTA acquired U.S. marketing rights for Xibrom in May 2002 under a license from Senju.
ISTA has completed two pivotal Phase III clinical studies of the twice- daily formulation of Xibrom in the United States. In these studies involving 527 patients, a statistically significant proportion of patients treated with Xibrom achieved treatment success, defined as the complete absence of ocular inflammation compared to those patients who received placebo. This effect was evident in the Xibrom group as early as day 3 following initiation of treatment. Furthermore, 75 per cent of patients were pain-free within two days of being treated with Xibrom twice daily. In addition, 93 per cent of patients receiving Xibrom twice daily were pain-free within six days of treatment.
The topical ophthalmic anti-inflammatory market consists of steroids, NSAIDs and combination products. Based upon 2005 prescription data from IMS, ISTA estimates that US sales in 2005 in this market were approximately $400 million, with total prescriptions of 8.8 million.