Omeros Corporation (Nasdaq: OMER) today announced that a Phase 2 clinical trial of OMS103HP, its PharmacoSurgery™ product candidate for arthroscopy, demonstrated that patients treated with OMS103HP during arthroscopic knee meniscectomy surgery achieved statistically significant clinical benefits. OMS103HP is an investigational drug product that is added to arthroscopic irrigation solution and is designed to improve postoperative joint function and motion and reduce postoperative pain.
The Phase 2 clinical trial was a multicenter, randomized, double-blind, vehicle-controlled study. Of the 161 patients who were enrolled and treated, 143 patients met the predetermined surgical criteria and were included in the data analysis (71 OMS103HP and 72 vehicle). There were no important differences in demographic characteristics between the two treatment groups.
This study has shown that OMS103HP provides greater efficacy than vehicle as measured by visual analog scale (VAS) pain scores, passive knee flexion and patient reported functional scores using the Knee Injury and Osteoarthritis Outcome Score (KOOS). The patient reported outcomes showed a sustained benefit through postoperative Day 90. OMS103HP was well tolerated, and adverse events were more frequent in the vehicle dose group.
Pain scores in the immediate 24-hour period and up to seven days postoperatively were measured using a validated, 100-point, VAS. Range of motion assessments were made at baseline and day seven postoperatively. The protocol was amended to collect patient self reports using the KOOS, which consists of five subscale scores: symptoms, pain, activities of daily living, sport and recreation function, and knee-based quality of life. The KOOS subset consisted of 67 subjects (33 OMS103HP and 34 vehicle).
"We are pleased with the clinical results of this Phase 2 trial, which show that OMS103HP significantly improved patients' functional scores, increased their knee flexion and decreased their pain after arthroscopy," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "These data are not only consistent with those from our earlier Phase 2 arthroscopic ACL trial that demonstrated functional improvement over a 30-day course of physical therapy, they showed sustained clinical benefit throughout an even longer 90-day follow-up period."