OMS302, added to standard irrigation solution used during ophthalmological procedures, is Omeros’ proprietary PharmacoSurgery product intended to maintain intraoperative mydriasis and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery, according to the company.
Omeros reported positive data from the second of two Phase 3 clinical trials evaluating OMS302 in patients undergoing intraocular lens replacement surgery. With positive data in both trials, Omeros now plans to submit the NDA to FDA in the first half of 2013.
“This [second] successful trial marks another major milestone for Omeros, our employees and our shareholders,” said Gregory A. Demopulos, MD, chairman and CEO of Omeros, in the release. “We are on track to submit an NDA in the first half of 2013 and a marketing authorization application shortly thereafter, and we are continuing to build out our commercialization plan in anticipation of a 2014 market launch.”
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