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Phase III trials commence for OMS 103HP for Arthroscopic Surgery

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Last updated:10th Aug 2012
Published:10th Aug 2012
Source: Pharmawand

Enrollment is complete in the first of two trials from Omeros Corporation, in patients undergoing arthroscopic partial meniscectomy Surgery. The Phase III clinical program for OMS 103HP is assessing the drug's safety and efficacy in improving postoperative joint function and reducing pain following arthroscopic partial meniscectomy surgery. The program is expected to consist of two randomized, double-blind, vehicle-controlled, multicenter trials. The primary endpoint for both trials will be performance on the Knee Injury and Osteoarthritis Outcome Score (KOOS), a validated patient-reported outcomes measure used in Omeros' earlier successful Phase II meniscectomy trial. The last patient enrolled in this Phase III clinical trial has undergone surgery and is now participating in the study protocol's postoperative evaluations.

Omeros expects to be able to announce data from this trial during the second half of 2012 after those evaluations are complete. Assuming positive data from the current trial, Omeros plans to initiate enrollment in its second Phase III meniscectomy trial following discussions with European regulatory authorities.

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