logo
Share SHARE
FONT-SIZE Plus   Neg

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

ISTA Pharmaceuticals, Inc. (ISTA) 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
Electric car maker Tesla's Chief Elon Musk confirmed that there will be no discount on new cars. Through several tweets and an email addressing its employees, Musk said, "It is absolutely vital that we adhere to the no negotiation and no discount policy that has been true since we first started taking orders 10 years ago." Shares of National Beverage Corp. fell about 15 percent on Wednesday after short selling firm Glaucus Research Group has said it is shorting the soft-drink maker and accused the company of manipulating earnings. In a research report, Glaucus alleged that National Beverage achieved its "remarkable history of financial performance in part by manipulating earnings." Canadian pipeline operator Enbridge Inc. said it has agreed to sell its liquids pipeline assets in the South Prairie Region, including the Saskatchewan pipeline system, to privately-held midstream company Tundra Energy Marketing Ltd. for C$1.075 billion in cash.
comments powered by Disqus
Follow RTT