The Phase I/II trial is a randomized, double-blind, vehicle-controlled and parallel-assigned study evaluating the effects of OMS302 on dilation of the pupil during cataract surgery and on pain, discomfort and inflammation following the procedure. OMS302 is added to standard irrigation solutions used in ophthalmologic surgery and is delivered directly to the eye during the operation.
At least 60 patients undergoing age-related cataract extraction with lens replacement are planned for enrollment in the study.
According to the company, PharmacoSurgery product candidates are proprietary 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.
Gregory Demopulos, chairman and CEO of Omeros, said: “With the initiation of this study, all three of Omeros’s current PharmacoSurgery product candidates are now in the clinic. Each of the two agents in OMS302 is currently used individually and perioperatively during eye surgery. OMS302 combines these two agents and their pharmacologic activities into a single proprietary product candidate.”