Drug begins phase 3 trials for improving post-arthroscopy knee function

OMS103HP is delivered during arthroscopic ACL reconstruction to inhibit inflammation and pain.

SEATTLE — Omeros Corp. has initiated phase 3 clinical trials for a drug used during arthroscopic ACL reconstruction to improve postoperative knee function, the company announced.

The drug, dubbed OMS103HP, is added to irrigation fluid and perfused through the joint during arthroscopic ACL reconstruction. It is intended to inhibit the acute inflammatory response that causes the swelling and pain associated with such procedures, which can lead to restricted joint motion and loss of function, according to a press release from Omeros, developers of the drug.

This is the first drug under development for improving postop joint function following arthroscopic procedures, the company noted.

“Traditionally, inflammation and pain are addressed postoperatively in an attempt to resolve them after they have begun,” Gregory A. Demopulos, MD, chairman and CEO of Omeros, said in the press release.

“We have taken a different approach with OMS103HP by delivering targeted therapeutic agents directly to the surgical site during the arthroscopic procedure - while the trauma is occurring - to inhibit inflammation and pain before it can begin,” he said.

“Early pain relief and functional recovery are important factors for patient satisfaction and outcomes. Avoiding a very painful, swollen knee in the early postoperative period has an immediate and lasting benefit, and can prevent complications that require additional therapy, rehabilitation time and even further surgery,” he added.

The phase 3 evaluation includes three double-blind, placebo-controlled and multicenter clinical trials that will enroll about 900 patients. The studies will evaluate postop improvement in knee function, as well as pain reduction, range-of-motion improvement and whether patients can return to work earlier.

The phase 3 evaluation follows prior phase 1 and phase 2 placebo-controlled studies conducted at Stanford University, which indicated OMS103HP significantly improved knee function following arthroscopic ACL reconstruction. In these studies, patients treated with the drug had less pain and better joint motion compared to patients receiving placebo. OMS103HP-treated patients also returned to work sooner and experienced only adverse events common following anesthesia and surgery, according to the press release.