ISTA Pharmaceuticals, Inc, said it submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Xibrom QD (once-daily). The company is seeking approval for Xibrom (bromfenac ophthalmic solution) QD as a treatment for inflammation, pain, and photophobia following cataract surgery.
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain. Xibrom, approved in 2005, is the first and only FDA-approved twice-daily NSAID for inflammation and reduction of 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 US marketing rights for Xibrom in 2002 and launched the product in the US in 2005.
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $3.2 billion US prescription ophthalmic industry include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The company currently markets three products and is developing a strong product pipeline to fuel future growth and market share.