Ista announces positive phase 3 results for new bromfenac solution

IRVINE, Calif. — Two phase 3 studies on Prolensa (bromfenac ophthalmic solution, Ista Pharmaceuticals) produced statistically significant positive results, Ista Pharmaceuticals announced today in a news release.

The multicenter, randomized, double-masked, parallel-group controlled studies compared the low-concentration bromfenac solution with placebo in 440 patients who underwent unilateral cataract surgery. Half were given bromfenac ophthalmic solution, and half were given placebo once daily beginning the day before surgery and continuing to 14 days postop, the release said.

Bromfenac ophthalmic solution produced significantly better results than placebo in the clinical program, according to the release, meeting the primary efficacy endpoint of absence of ocular inflammation at 14 days postop and the secondary endpoint of elimination of ocular pain at 1 day postop. There were no serious drug-related adverse events, Ista reported.

The company intends to file a new drug application for Prolensa in the first quarter of 2012, according to the release.

"Assuming timely approval and commercial launch, we will focus the sales force on converting the 4,500+ ophthalmologists who prescribe the majority of the once-daily Bromday (bromfenac ophthalmic solution 0.09%, Ista) to prescribe Prolensa," Vicente Anido Jr., PhD, president and chief executive officer of Ista said in the release. "We plan to discontinue Bromday sometime after the successful launch of Prolensa."