Pharmaceutical Business review

Omeros initiates enrollment in Phase III trial of OMS302

The trial will enroll approximately 400 patients undergoing cataract surgery or refractive lens exchange.

The randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety measures and data are expected in the second half of 2012.

OMS302 is added to standard irrigation solution used during ILR procedures to maintain intraoperative mydriasis (pupil dilation) and reduce postoperative pain, the company said.

Omeros chairman and chief executive officer Gregory Demopulos said: "Our previous OMS302 trials enrolled rapidly, and we expect a similar enrollment rate in this trial. We have begun preparing our NDA and, assuming positive data, are targeting a submission date in the first part of 2013."