The Phase I randomized, double-blind, vehicle-controlled and parallel-assigned study of OMS201 evaluates the systemic absorption and safety of OMS201 in patients receiving primary treatment by endoscopic removal of urinary stones. At least 24 patients undergoing unilateral ureteroscopic removal of stones with a maximum diameter of 12mm located in the renal-collecting system or ureter will be enrolled in the study.
OMS201, developed from Omeros’s PharmacoSurgery platform, is designed for use during urological surgery, including uroendoscopic procedures such as ureteroscopy, cystoscopy and minimally invasive prostate procedures. Added to standard irrigation solutions in urological surgery, OMS201 is delivered during the operation directly to the surgical site to inhibit surgically induced inflammation, pain and smooth muscle spasm.
OMS201 is one of the four clinical development programs in the company’s PharmacoSurgery platform. PharmacoSurgery product candidates are combinations of therapeutic agents designed to act simultaneously at multiple discrete targets to preemptively block the molecular-signaling and biochemical cascade caused by surgical trauma and to provide clinical benefits both during and after surgery.