logo
Share SHARE
FONT-SIZE Plus   Neg

ISTA Pharma Presents Results From One Of Two Phase 3 Studies Of PROLENSA

ISTA Pharmaceuticals, Inc. (ISTA: Quote) presented results from one of two Phase 3 studies of PROLENSA (bromfenac ophthalmic solution), the company's once-daily topical nonsteroidal anti-inflammatory product candidate for the treatment of ocular inflammation and pain following cataract surgery.

According to the company, the findings showed PROLENSA was statistically greater than placebo in clearing subjects' ocular inflammation by day 15 and eliminating ocular pain one day post-surgery, the study's primary and secondary endpoints, respectively.

ISTA Pharma noted that it plans to file a New Drug Application with the U.S. Food and Drug Administration, or FDA, for PROLENSA in the first half of 2012.

Also, additional data from the poster presentation, titled "Phase III Clinical Trial of Low Concentration Bromfenac Ophthalmic Solution Dosed Once Daily for Postoperative Ocular Inflammation and Pain", showed there were no serious drug-related ocular or systemic adverse events, and PROLENSA's safety profile was consistent with the company's currently marketed once-daily topical nonsteroidal anti-inflammatory compound, BROMDAY (bromfenac ophthalmic solution) 0.09%.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
BlackRock (BLK) said its iShares division has launched the iShares Short Maturity Municipal Bond ETF (MEAR). The move by iShares, the world's largest manager of exchange traded funds, is part of efforts to boost its lineup of fixed income ETFs. iShares Short Maturity Municipal Bond ETF is actively... The drought crisis in California will not abate any time soon despite the onset of a somewhat weak El Nino, endangering crops and putting farmers and others to hardship. German auto giant BMW has refuted reports it is in discussion with tech giant Apple Inc. (AAPL) related to the making of an electric car. BMW has clarified that its discussion with Apple was not related to building an electric car but were "regular talks," according to a report from Reuters. On...
comments powered by Disqus
Follow RTT