FDA Approves Omeros' Omidria For Cataract and Intraocular Lens Surgery
By Cyndi Root
Omeros Corporation announced in a press release that the Food and Drug Administration (FDA) has approved Omidria (phenylephrine and ketorolac injection). The pupil-dilating agent is for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative pain. The FDA did not require post-marketing studies besides the pediatric patient study that Omidria already agreed to perform.
Gregory A. Demopulos, chairman and CEO of Omeros, said, "We have continued to round out our commercialization team and are focused on obtaining European approval for Omidria, securing Medicare pass-through reimbursement and successfully launching the product in the U.S. later this year.”
Omidria
Omidria is a mydriatic (pupil-dilating) and anti-inflammatory agent composed of phenylephrine and the anti-inflammatory agent ketorolac. The agent is suspended in an irrigation solution used in eye surgeries. It prevents intraoperative miosis, reduces postoperative pain, and helps physicians manage ophthalmic surgery. Miosis and pain occurs frequently, making the surgeon’s task more difficult and the patient’s experience unpleasant. The agent will not change the surgical procedures but will instead improve surgical outcomes. Additionally, the need for preoperative NSAIDs may be less due to the ketorolac in Omidria.
Clinical trials showed statistically significant improvement in miosis and pain. Adverse reactions were similar between Omidria and a placebo and included posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. Omidria is not approved for children but the company will conduct trials in that indication, which will give it another six months of marketing exclusivity. Omeros has applied to the European Medicines Agency (EMA) for approval of Omidria.
About Omeros
Omeros Corporation is a Seattle-based company focused on discovering and marketing small-molecule and protein therapeutics. It targets large markets and rare conditions. The company works on problems associated with surgery, schizophrenia, Huntington's disease, cognitive impairment, and addiction. Omeros is also working with G-protein coupled receptor (GPCR) drugs and compounds. In April 2014, the FDA approved Omeros’ Investigational New Drug Application (IND) for OMS721 for the treatment of thrombotic microangiopathies (TMAs). In March, the company announced positive data for OMS721 in atypical hemolytic uremic syndrome (aHUS), a form of TMA, following another announcement of positive data from a Phase I program for OMS824 for cognitive disorders.