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FDA approves once-daily bromfenac ophthalmic solution
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CHICAGO — The U.S. Food and Drug Administration has approved Ista Pharmaceuticals' supplemental New Drug Application for a 0.09% formulation of bromfenac ophthalmic solution, the company announced in a press release.
Bromday (bromfenac ophthalmic solution 0.09%) — formerly called XiDay — received the sNDA as a once-daily prescription eye drop in postoperative inflammation treatment. The eye drop also reduces ocular pain in cataract extraction patients.
"Simplification is the way to get better patient compliance and therefore better results," Uday Devgan, MD, FACS, said at an Ista-sponsored event here at the joint meeting of the American Academy of Ophthalmology and the Middle East Africa Council of Ophthalmology. "[Bromday] helps you achieve your desired outcomes with patients."
"We believe the convenience of a once-daily eye drop will help with treatment compliance and benefit patients recovering from cataract surgery," Vicente Anido, Jr., PhD, president and CEO of Ista, said in the release.
The company plans to launch Bromday before the end of 2010 and plans to discontinue its twice-daily Xibrom (bromfenac sodium ophthalmic solution 0.1%) in early 2011, according to the release.
"Within just a few weeks, our expanded sales force will be ready to promote Bromday to U.S.-based ophthalmologists, along with Bepreve, our recently launched eye drop for the treatment of itching associated with allergic conjunctivitis," Dr. Anido said.