HOME | SITE MAP | CONTACT US | PARTNERS

 
R & D
Pipeline
Vitrase®
Istalol®
Xibrom™
Xibrom QD™
Ecabet Sodium
T-Pred™
Bepotastine
Strong Steroid
Research And Development
Xibrom™ Overview:

Xibrom™ ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. For more details, including prescribing info , click here . The product was developed by Senju in Japan. Senju launched Xibrom in Japan with the tradename Bronuck® in 2000. We believe its rapid sales growth is principally due to its potency and twice-daily dosing regimen, as compared to the requirement of four doses-per-day for most other anti-inflammatory products on the Japanese market. In May 2002, as part of our AcSentient asset acquisition, we acquired marketing rights for Xibrom™ in the United States.

How Xibrom™ Works (Mechanism of Action):
Xibrom™ is a member of the class of non-steroidal anti-inflammatory drugs (NSAIDS). These are aspirin-like drugs that are inhibitors of prostaglandins. These are a group of compounds that act in tissues where they are liberated to elicit various inflammatory activities. Prostaglandins are generated in most tissues by activation of the arachidonic acid pathway. Briefly, phospholipids in the cell membrane are the substrate for the enzyme phospholipase A to cause generation of arachidonic acid and, in turn, the enzymes cyclo-oxygenases and lipoxygenases act on arachidonic acid to produce a family of chemically distinct prostaglandins (cyclo-oxygenases), and leukotrienes (lipoxygenases).

Xibrom™, like other NSAIDS, acts primarily to inhibit cyclo-oxygenases and prevents the formation of prostaglandins. This subsequently decreases the inflammation in the site of action following drug penetration. Thus, Xibrom™ treatment of eyes with inflammation following cataract surgery may stop the formation of prostaglandin and halt the inflammatory response to surgical trauma.

Xibrom™ Market Opportunity:
According to prescription data compiled for us by IMS Health, we estimate that the current U.S. ophthalmic anti-inflammatory market to be approximately $250 million per year. Currently in the U.S., we estimate that there are over 5.4 million prescriptions written annually for topical ophthalmic anti-inflammatory agents.

Xibrom™ Clinical/Regulatory Status:
Phase I, Phase II and Phase III clinical studies of Xibrom™ have been completed in Japan and the product has been approved and was launched in 2000 in Japan. In December 2003, we completed enrollment of our Phase III clinical studies in the United States and announced initial results of our clinical studies in March 2004. In two double-masked, placebo-controlled U.S. Phase III studies conducted under a single protocol, a statistically significant proportion of patients treated with Xibrom™ achieved treatment success as compared to placebo. Treatment success was defined as the complete absence of ocular inflammation. In one study involving 296 patients at 20 study sites, more Xibrom™ -treated patients cleared their ocular inflammation at 15 days when compared to patients receiving placebo at a rate of 62.6% versus 39.8%, respectively. In a second U.S. study, which involved 231 patients at 19 study sites, the rates of ocular inflammation clearance at the primary endpoint of 15 days were 65.8% for Xibrom™ -treated patients and 47.9% for patients receiving placebo. Statistical significance in each trial reached a p value of less than 0.01. Our analyses showed that the Xibrom™ treatment effect was evident as early as day three in both trials. The primary endpoint for both studies was the proportion of patients with complete absence of ocular inflammation, as measured by an assessment of immune cells in the anterior chamber of the eye and cellular debris. For each trial, the secondary efficacy analysis of inflammation clearance in patients only on assigned treatment (with no other medications administered) also showed a statistically significant benefit for Xibrom™ treatment at 15 days versus placebo. In the 20-site study, the rates of clearance were 57.6% for Xibrom™ and 23.5% for placebo. In the 19-site study, the rates of clearance were 62.0 % for Xibrom™ and 31.5 % for placebo. Both studies, when analyzed separately, also showed that Xibrom™ was well tolerated with a very low incidence of ocular adverse events. The efficacy and safety findings were consistent with results of previous studies conducted in Japan by Senju. Xibrom™ received U.S. FDA approval in March 2005.

© 2007 ISTA Pharmaceuticals. All Rights Reserved. Disclaimer | Privacy Policy