Ista Pharmaceuticals, Inc. announced the US Food and Drug Administration (FDA) has granted the company three years of marketing exclusivity for Bromday (bromfenac ophthalmic solution) 0.09 per cent, as provided under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act. Bromday (formerly referred to as XiDay), the first and only once-daily prescription eye drop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction, was approved by the FDA in October of 2010. Under the Hatch-Waxman Act, the FDA may not approve an Abbreviated New Drug Application for a generic version of Bromday until October of 2013.
Ista also announced it recently shipped the first orders of Bromday to wholesalers and expects Bromday to be available in pharmacies beginning this week. The ISTA sales force has begun detailing Bromday to ophthalmologists, and the company expects to discontinue the twice-daily Xibrom product in early 2011.
Bromday is a once-daily eye drop formulation of a non-steroidal anti-inflammatory compound for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction. It is approved for dosing once-daily beginning one day prior to surgery, on the day of surgery and continuing for the first 14 days after surgery. Since 2005, Ista has marketed Xibrom (bromfenac ophthalmic solution) 0.09 per cent in the US for twice-daily use for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery.
Ista acquired US ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co. Ltd. Xibrom is the 2010 dollar market share leader in the $335 million US ophthalmic non-steroidal anti-inflammatory market. Ista reported Xibrom net sales of $81.1 million for the year ended December 31, 2009, and net sales of $71 million in the first nine months of 2010, up 29 per cent over the first nine months of 2009.
Bromday is a Non-Steroidal Anti-Inflammatory Drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
ISTA Pharmaceuticals, Inc. is the fourth largest and fastest growing branded prescription eye care business in the United States, with an expanding focus on allergy therapeutics. The company currently markets five products, including treatments for ocular inflammation and pain associated with cataract surgery, glaucoma, and ocular itching associated with allergic conjunctivitis.