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news.Omeros has initiated the planned pharmacokinetic (PK) substudy in its Phase III clinical program designed to evaluate OMS302, a pharmacosurgery product, in patients undergoing intraocular lens replacement (ILR) surgery.
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The PK substudy will confirm the low levels of systemic exposure previously observed in preclinical studies of the product.
The company will collect the blood samples earlier to and during the first 24 hours after surgery from twelve OMS302- and placebo-treated patients in the ongoing second OMS302 Phase III trial.
The company plans to include the obtained data in the OMS302 marketing applications in the US and the EU.
Omeros chairman and chief executive officer Gregory Demopulos said that the recent discussions with US and EU regulators confirmed the company’s expectations that this 24-patient substudy should provide sufficient PK data for our OMS302 marketing applications.
OMS302 is added to standard irrigation solution used during ILR procedures to maintain intraoperative mydriasis (pupil dilation) and reduce postoperative pain, the company said.