Omeros announces positive OMS302 safety data in Phase 3 clinical trial Omeros announced the successful completion of the 90-day safety database lock in the second of the company's two pivotal Phase 3 clinical trials evaluating OMS302 in patients undergoing intraocular lens replacement surgery. OMS302 is Omeros' proprietary PharmacoSurgery product designed to maintain intraoperative mydriasis and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery. Safety data were collected through postoperative day 90. In this Phase 3 clinical trial, OMS302 was well tolerated. No safety concerns have been identified in the OMS302 clinical development program.
Omeros receives positive opinion from EMA's committee for Omidria Omeros announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for Omidria 1%/0.3%. Omidria is used during cataract surgery and other intraocular lens replacement procedures to maintain mydriasis, prevent miosis, and reduce postoperative eye pain. Cataract surgery and IOL replacement are among the most common surgical procedures worldwide, with approximately 3.9 million of them expected to be performed in Western Europe alone in 2015. Omidria was approved by the FDA in 2014 and last month was made broadly available nationwide for commercial use.