ISTA Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that the US Food & Drug Administration (FDA) has approved the New Drug Application (NDA) for Xibrom (bromfenac ophthalmic solution) 0.09 per cent for the treatment of ocular inflammation following cataract surgery.
ISTA expects to launch Xibrom, a topical, twice-daily, non-steroidal anti-inflammatory solution (NSAID), during the second quarter of 2005, after securing commercial quantities of the product from its manufacturer and completing the further expansion of its sales force.
Eric Donnenfeld, MD, Associate Professor of Ophthalmology, New York University Medical Center, New York and an investigator in the Xibrom Phase III clinical trials, commented, "Xibrom is the first twice-daily ophthalmic NSAID to be approved in the United States. All other ophthalmic NSAIDS are dosed four times daily. Xibrom represents an advance for ophthalmic care because of the improved patient compliance and its early onset of action, and I am pleased that patients will have this new treatment option."
Vicente Anido, Jr, Ph.D., president and chief executive officer of ISTA stated, "We are excited to receive FDA approval of our third commercial product and anticipate launching Xibrom during the second quarter of 2005. We recently completed the interim expansion of our sales force which is now promoting Istalol and Vitrase. With the Xibrom approval, we plan on hiring additional sales representatives in order to reach approximately 10,000 ophthalmologists in the US."
Xibrom (bromfenac ophthalmic solution) 0.09 per cent is a sterile, topical, non- steroidal anti-inflammatory compound for the treatment of ocular inflammation following cataract surgery. Senju Pharmaceuticals Co. Ltd. has marketed this product in Japan since 2000. ISTA acquired U.S. marketing rights for Xibrom in May 2002 under a license from Senju. ISTA completed two pivotal Phase III clinical studies 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. ISTA filed its NDA for Xibrom with the FDA in May 2004.
According to company estimates and data compiled by IMS Health, the US ophthalmic anti-inflammatory market, consisting of steroids, NSAIDS and other related products, is approximately $250 million per year.