XibromTreatment for Postoperative Ocular Inflammation
ISTA Pharmaceuticals Announces Submission of Xibrom NDA to the FDA
IRVINE, Calif., May 25, 2004 -- ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA) today announced that ISTA has filed with the Food and Drug Administration (FDA) its New Drug Application (NDA) for Xibrom (bromfenac sodium ophthalmic solution) 0.1%. A topical, twice-daily, non-steroidal anti- inflammatory solution, Xibrom is initially being developed for the treatment of ocular inflammation following cataract surgery.
Vicente Anido, Jr., Ph.D., ISTA's Chief Executive Officer, commented, "We are pleased with the continued progress of Xibrom, one of our key late-stage product candidates. In contrast to current competitors' products in the non- steroidal anti-inflammatory category, which are commonly administered four times per day, we believe Xibrom's twice-daily dosing and a favorable side effect profile provide significant advantages. Assuming FDA acceptance of our NDA filing, we look forward to working with the FDA in its review of Xibrom."
In March 2004, ISTA reported that, in two double-masked, placebo- controlled U.S. Phase III studies of Xibrom conducted under a single protocol, a statistically significant proportion of patients treated with Xibrom achieved treatment success, defined as the complete absence of ocular inflammation, when compared to placebo. Analyzed separately, both studies also showed that Xibrom was well tolerated with a very low incidence of ocular adverse events.
Xibrom (bromfenac sodium ophthalmic solution) 0.1%
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation. Xibrom was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in May 2002 under a license from Senju.
ISTA is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products. ISTA's products seek to address serious diseases and conditions of the eye such as vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma, ocular pain and inflammation. Building on this pipeline, ISTA's goal is to continue its growth as a specialty pharmaceutical company by acquiring complementary products, either already marketed or in late-stage development.
For additional information regarding ISTA, please visit ISTA Pharmaceuticals' website at www.istavision.com.
Posted: May 2004
- Xibrom - ISTA Pharmaceuticals, Inc. - New Indication Approved - January 27, 2006
- Xibrom ISTA Pharmaceuticals, Inc. - Treatment for Ocular Inflammation Following Cataract Surgery - March 24, 2005
- FDA Accepts ISTA Pharmaceuticals' New Drug Application for Xibrom - July 26, 2004