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Omeros Corporation Reports Fourth Quarter and Year-End 2012 Financial Results

rphan GPCRs. These four orphans –  GPR65/TDAG8, GPR82, MRGE and MRGF – are linked to a series of important indications, including several types of cancer and inflammatory disorders, such as asthma (GPR65/TDAG8), appetite and body weight (GPR82) and pain (MRGE and MRGF). Omeros also recently announced its ability to unlock Class B orphan GPCRs.
  • Reported positive data from its second pivotal Phase 3 clinical trial evaluating OMS302 in patients undergoing intraocular lens replacement surgery.  OMS302 met its co-primary endpoints by demonstrating statistically significant (p<0.00001) maintenance of intraoperative mydriasis (pupil dilation) and statistically significant (p=0.0002) reduction of pain in the early postoperative period. Now with positive data from both trials in the OMS302 Phase 3 clinical program, Omeros plans to submit a New Drug Application with the U.S. Food and Drug Administration in the first half of 2013 and a Marketing Authorization Application with the European Medicines Agency in mid-2013. Omeros is building its marketing and sales capabilities in expectation of OMS302's planned commercial launch in 2014.
  • Announced promising data from the single-ascending-dose (SAD) study portion of its Phase 1 clinical trial evaluating OMS824, the lead compound in Omeros' phosphodiesterase 10 (PDE10) program for schizophrenia and cognitive disorders.  In this SAD study, OMS824 was well tolerated and demonstrated linear pharmacokinetics, a long half-life consistent with once daily dosing and good systemic exposure that resulted in the expected pharmacological effects in healthy subjects.  With these encouraging data, Omeros advanced OMS824 to the next stage of the Phase 1 clinical program – the evaluation of multiple-ascending dosing (MAD) of the compound.  Omeros expects to report data from this MAD trial in the near future. 
  • Completed the first Phase 3 clinical trial compar

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