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
British lender Lloyds Banking Group Plc. Friday reported higher profit in its first half, benefited by increased net interest income and margin as well as lower impairment. Looking ahead, the company lifted its net interest margin forecast. Amgen reported an increase in second-quarter profit, driven by sales of arthritis drug Enbrel and osteoporosis treatments Xgeva and Prolia, and improved margins. Both earnings and sales topped Wall Street estimates. Electronic Arts Inc. (EA) on Thursday reported an increase in profit for the first quarter, reflecting continued strong digital revenues, with both earnings and revenues topping Wall Street estimates. However, shares of the company fell over 4 percent, after having detailed a weak outlook. Redwood...
comments powered by Disqus
Follow RTT