BioCentury
ARTICLE | Top Story

OMS103HP misses Phase III endpoint

December 28, 2012 12:48 AM UTC

Omeros Corp. (NASDAQ:OMER) said OMS103HP missed the primary endpoint of improving knee symptoms from baseline to day 30 vs. vehicle irrigation solution in a Phase III trial of the product to improve post-operative joint function and to reduce pain following arthroscopic partial meniscectomy surgery. OMS103HP did meet the secondary endpoint of reducing post-operative pain as measured by a visual analog scale (VAS) vs. vehicle (p=0.0003). The double-blind, U.S. trial enrolled 344 patients.

Omeros said a second Phase III trial of OMS103HP in the indication is on track to start in 1H13. The company said the primary endpoint for the second trial will be pain scores as measured by a VAS. OMS103HP is a combination of ketoprofen, amitriptyline and oxymetazoline added to standard arthroscopic irrigation solutions. ...