IRVINE, Calif., Dec. 17 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced the Company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for bromfenac ophthalmic solution dosed once-daily as a treatment for ocular inflammation and pain following cataract surgery. ISTA currently markets Xibrom™ (bromfenac ophthalmic solution) 0.09%, which is an eye drop labeled for use twice-daily, beginning 24 hours after cataract surgery. If approved, ISTA plans to market the once-daily product under the brand name XiDay™.
ISTA filed the XiDay sNDA electronically in eCTD format. Pending FDA validation of the electronic file in the coming days and timely acceptance of the filing by the FDA, ISTA expects a standard review of six months from date of receipt.
Xibrom™ (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the product in the U.S. in 2005. Xibrom is the 2009 year-to-date dollar market share leader in the U.S. ophthalmic non-steroidal anti-inflammatory market. ISTA reported Xibrom net sales of $55.1 million for the nine-month period ended September 30, 2009.
Xibrom currently is labeled as an eye drop used twice-daily beginning 24 hours after cataract surgery. Xibrom has not been approved by the FDA as a once-daily treatment. ISTA's sNDA filing requests the Agency approve a change to bromfenac ophthalmic solution's label to reflect its efficacy as a once-daily treatment in this patient population.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is the fourth largest branded ophthalmic pharmaceutical business in the U.S. ISTA's four marketed products plus its product candidates include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company is developing a strong product pipeline to fuel future growth and market share, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S. For additional information regarding ISTA, please visit ISTA Pharmaceuticals' website at http://www.istavision.com.
Xibrom™ (bromfenac ophthalmic solution) 0.09%, and XiDay™ are trademarks of ISTA Pharmaceuticals.
Forward-looking Statements
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to the FDA's timely acceptance and approval of XiDay, ISTA's belief that the FDA will review and take action on XiDay within six months of filing and ISTA's expectation of becoming the leading niche ophthalmic pharmaceutical company are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others, delays and uncertainties related to the FDA or other regulatory agency approval or actions and such other risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2008, and its most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2009.
SOURCE ISTA Pharmaceuticals, Inc.
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ISTA filed the XiDay sNDA electronically in eCTD format. Pending FDA validation of the electronic file in the coming days and timely acceptance of the filing by the FDA, ISTA expects a standard review of six months from date of receipt.
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Xibrom™ (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the product in the U.S. in 2005. Xibrom is the 2009 year-to-date dollar market share leader in the U.S. ophthalmic non-steroidal anti-inflammatory market. ISTA reported Xibrom net sales of $55.1 million for the nine-month period ended September 30, 2009.
Xibrom currently is labeled as an eye drop used twice-daily beginning 24 hours after cataract surgery. Xibrom has not been approved by the FDA as a once-daily treatment. ISTA's sNDA filing requests the Agency approve a change to bromfenac ophthalmic solution's label to reflect its efficacy as a once-daily treatment in this patient population.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is the fourth largest branded ophthalmic pharmaceutical business in the U.S. ISTA's four marketed products plus its product candidates include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company is developing a strong product pipeline to fuel future growth and market share, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S. For additional information regarding ISTA, please visit ISTA Pharmaceuticals' website at http://www.istavision.com.
Xibrom™ (bromfenac ophthalmic solution) 0.09%, and XiDay™ are trademarks of ISTA Pharmaceuticals.
Forward-looking Statements
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to the FDA's timely acceptance and approval of XiDay, ISTA's belief that the FDA will review and take action on XiDay within six months of filing and ISTA's expectation of becoming the leading niche ophthalmic pharmaceutical company are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others, delays and uncertainties related to the FDA or other regulatory agency approval or actions and such other risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2008, and its most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2009.
SOURCE ISTA Pharmaceuticals, Inc.
