logo
Plus   Neg
Share
Email

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 RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Alphabet Inc. (GOOG, GOOGL), the parent company of Google, Monday reported a surge in profit for the first quarter, primarily reflecting strong revenue growth in search and advertising. Alphabet's first-quarter profit surged to $9.40 billion or $13.33 per share from $5.43 billion or $7.73 per share... Canadian restaurant chain Tim Hortons woes seem to be only mounting. However, most of the company's troubles seem to be self-inflicted amid a public feud with its aggrieved franchisees, alleged deterioration in food quality, and falling share prices. Tim Hortons was acquired by Brazilian private equity firm 3G Capital for $12.5 billion in 2014. An unruly passenger was tasered, arrested and forcibly removed from an American Airlines flight on Sunday evening after he allegedly touched a female passenger inappropriately. Prior to takeoff, the boyfriend of the female passenger on the plane contacted authorities after the unruly passenger, Jacob Garcia, began touching her. Garcia was subsequently arrested by the police.
Follow RTT