Once-daily bromfenac 0.09% approved

Irvine, CA-The FDA has approved a supplemental new drug application for a once-daily bromfenac 0.09% ophthalmic solution (Bromday [formerly called XiDay], ISTA Pharmaceuticals) for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction, according to the company.

The drug should be available before the end of the year, and the company’s twice-daily formulation of bromfenac 0.09% (Xibrom), marketed since 2005, will be discontinued early next year.

“We believe the convenience of a once-daily eye drop will help with treatment compliance and benefit patients recovering from cataract surgery,” said Vicente Anido Jr., PhD, president and chief executive officer of ISTA.

“Since the . . . approval process required additional clinical investigations beyond those conducted for the original approval of [the twice-daily solution], we are seeking a 3-year exclusivity period under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act,” he added.

The new drop is approved for once-daily dosing beginning 1 day before surgery, on the day of surgery, and continuing for the first 14 days after surgery. In studies, the most commonly reported adverse reactions, in 2% to 7% of patients each, were abnormal sensation in the eye, conjunctival hyperemia, and eye irritation (including burning/stinging).