FDA Approves First Once-Daily Ophthalmic NSAID for Use in Cataract Surgery

Yael Waknine

October 25, 2010

October 25, 2010 — The US Food and Drug Administration (FDA) has approved a once-daily formulation of bromfenac 0.09% ophthalmic solution (Bromday; made by Ista Pharmaceuticals, Inc, under license from Senju Pharmaceutical Co Ltd) for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery.

Use of the novel once-daily eye drop is expected to improve patient therapeutic compliance compared with the company's previously approved twice-daily formulation (Xibrom), which will be discontinued in early 2011.

"Bromday is the only once-daily ophthalmic nonsteroidal anti-inflammatory drug...for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction," said Vicente Anido, Jr, PhD, president and chief executive officer of Ista, in a company news release. "We believe the convenience of a once-daily eye drop will help with treatment compliance and benefit patients recovering from cataract surgery."

Once-daily bromfenac 0.9% ophthalmic solution should be applied to the affected eye or eyes as a single drop, beginning 1 day before cataract surgery and continued through the first 2 weeks of the postoperative period. Adverse events reported in 2% to 7% of patients include abnormal eye sensation, conjunctival hyperemia, and eye irritation such as burning/stinging.

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