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Once-daily NSAID candidate has positive results in phase 3 study

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IRVINE, Calif. — Ista Pharmaceuticals released positive results from one of two phase 3 studies of the company’s once-daily topical nonsteroidal anti-inflammatory product candidate for the treatment of ocular inflammation and pain following cataract surgery, according to a company press release.

The study showed Prolensa (bromfenac ophthalmic solution) was statistically greater than placebo in clearing subjects’ ocular inflammation after 15 days and eliminating ocular pain 1 day after surgery.

The drug demonstrated no serious ocular or systemic adverse events, and its safety profile was consistent with Bromday (bromfenac ophthalmic solution 0.09%), Ista’s once-daily topical NSAID, the release said.

Ista intends to file a new drug application with the U.S. Food and Drug Administration for Prolensa in the first half of this year.