Omeros submits OMS302 NDA to FDA for patients undergoing ILR surgery

Aug 1 2013

Omeros Corporation (NASDAQ: OMER) announced that the company recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for approval of OMS302 for use in patients undergoing intraocular lens replacement (ILR) surgery. Added to standard irrigation solution used during ILR, OMS302 is Omeros' proprietary PharmacoSurgery™ product that, across multiple human trials, demonstrated clinically meaningful and statistically significant maintenance of intraoperative mydriasis (pupil dilation), prevention of intraoperative miosis (pupil constriction), and reduction of postoperative ocular pain.

In addition, Omeros plans to submit a Marketing Authorization Application to the European Medicines Agency (EMA) via the EMA's centralized procedure this quarter. The company has recently been granted designation by the EMA as a Small or Medium-Sized Enterprise (SME). Through the SME program, Omeros can benefit from elimination or reduction of certain fees related to the clinical development and approval processes in Europe for OMS302 and other Omeros products.

"OMS302 fills a need recognized by all ophthalmic surgeons and does so without requiring them to change their routine operating procedures," stated Eric B. Donnenfeld, M.D., clinical professor of ophthalmology at New York University and president of the American Society of Cataract and Refractive Surgery. "Based on the results of the clinical trials, OMS302 has the potential to improve outcomes in all lens replacement surgeries. I look forward to being able to use the product in my practice – it provides benefits to both patients and their surgeons."

"This NDA submission represents the culmination of a tremendous amount of work by the Omeros team and our collaborators and a major milestone for the company, our employees and our shareholders," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We are preparing for a successful market launch of OMS302 and look forward to completing the transition from a development-stage to a commercial company. We expect that OMS302 will generate revenues that continue to drive our pipeline, yielding a long line of Omeros products to improve the lives of patients."