Ista gains FDA approval of once-daily bromfenac eye drops, to replace Xibrom
This article was originally published in Scrip
The ophthalmic specialty company Ista Pharmaceuticals has gained FDA approval of its supplemental new drug application for Bromday (bromfenac ophthalmic solution 0.09%), a once-daily formulation of the NSAI that it already markets in a twice-daily formulation under the brand name Xibrom.
The company has gained approval of Bromday as a treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction – the only once-daily NSAI with FDA approval for this indication. Ista says it expects to begin detailing its new product in mid-November, and plans to discontinue the twice-daily Xibrom product in early 2011. (Xibrom is the leading topical ophthalmic NSAI in the US.)
"Within just a few weeks, our expanded sales force will be ready to promote Bromday to US-based ophthalmologists, along with Bepreve, our recently launched eye drop for the treatment of itching associated with allergic conjunctivitis," said president and CEO Dr Vicente Anido.
Since the Bromday approval process required additional clinical investigations beyond those conducted for the original approval of Xibrom 0.09%, the company is seeking a three-year exclusivity period under the Hatch-Waxman Act.
The bromfenac-based product line was established when the company launched Xibrom in 2005, for topical treatment of ocular inflammation following cataract surgery, which was expanded in 2006 to include the treatment of pain following cataract surgery. Ista licensed US rights to Xibrom from Senju Pharmaceuticals in 2002. Ista reported Xibrom net sales of $81.1 million for the year ending 31 December 2009, and net sales of $41.4 million in the first six months of 2010, up 22% over the first six months of 2009.
Ista is also evaluating a new formulation and lower concentrations of bromfenac called Remura for the potential treatment of dry eye which is now in Phase III trials.