Tuesday, October 19, 2010

FDA approval for Ista Pharma’s Bromday eye drop

Cataract in Human EyeWikipedia
Food and Drug Administration
has approved Ista Pharmaceutical's drug Bromday (bromfenac ophthalmic solution) as a once-daily eye drop to treat inflammation and reduce pain in patients following cataract extraction. Shares of Ista Pharmaceuticals Inc. rallied on Monday after this announcement.
Ista already sells Xibrom [bromfenac ophthalmic], a twice-daily eye drop for postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery.
The company reported Xibrom net sales of $81.1 million in 2009. Once Bromday is established with ophthalmologists in the U.S., the company will discontinue Xibrom (bromfenac ophthalmic solution). Xibrom was the first twice-daily NSAID approved for the treatment of this specific problem. It is the revenue leader and one of the fastest growing products in the $335 million U.S. ocular inflammation market. Xibrom revenues in the first half of 2010 were $41 million. The company expects 2010 revenues for Xibrom and Bromday combined of $95–105 million.

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