omeros corp (OMER) Key Developments
Omeros Corporation Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2015
Nov 9 15
Omeros Corporation reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2015. For the quarter, the company reported total revenue of USD 3.259 million compared to USD 0.214 million a year ago. Loss from operations was USD 19.301 million compared to USD 17.132 million a year ago. Net loss was USD 19.921 million compared to USD 18.327 million a year ago. Basic and diluted net loss per share was USD 0.53 compared to USD 0.54 a year ago.
For the nine months, the company reported total revenue of USD 6.834 million compared to USD 0.359 million a year ago. Loss from operations was USD 53.198 million compared to USD 50.033 million a year ago. Net loss was USD 55.27 million compared to USD 52.96 million a year ago. Basic and diluted net loss per share was USD 1.48 compared to USD 1.61 a year ago.
Omeros Corporation to Report Q3, 2015 Results on Nov 09, 2015
Nov 2 15
Omeros Corporation announced that they will report Q3, 2015 results at 5:00 PM, Eastern Standard Time on Nov 09, 2015
Omeros Corporation, Q3 2015 Earnings Call, Nov 09, 2015
Nov 2 15
Omeros Corporation, Q3 2015 Earnings Call, Nov 09, 2015
Omeros Corporation Announces OMIDRIAssure to Expand Patient Access to Omidria®
Oct 15 15
Omeros Corporation announced that it has launched OMIDRIAssure, a comprehensive reimbursement services program to provide expanded access to Omidria® (phenylephrine and ketorolac injection) 1% /0.3% for cataract surgery patients and reimbursement assistance for physicians and facilities. The program services include the: OMIDRIAssure Information Hotline for physicians and facilities seeking personalized help and information on Omidria coverage and reimbursement; 'Equal Access' Patient Assistance Program providing assistance to financially eligible uninsured or government-insured patients; and the company Pay the Difference' Commercial Reimbursement Program providing assistance to patients with insufficient commercial insurance. Omidria is the first and only FDA-approved intraocular product that both prevents intraoperative miosis and reduces postoperative ocular pain. Omidria was granted transitional pass-through reimbursement status by the Centers for Medicare and Medicaid Services (CMS) and is reimbursed by CMS separately, and in addition to, the packaged payment for cataract surgery and lens replacement procedures.
Omeros Corporation Announces Additional Positive Data in OMS721 Phase 2 Clinical Trial
Aug 18 15
Omeros Corporation announced additional positive data in the company's Phase 2 clinical trial of OMS721 for the treatment of thrombotic microangiopathies (TMAs). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) 'aggregations of platelets' in the microcirculation of the body's organs, most commonly the kidney and brain. OMS721 is Omeros' lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of TMAs, including atypical hemolytic uremic syndrome (aHUS). The Phase 2 trial is designed to enroll primarily aHUS patients but can also enroll patients with thrombotic thrombocytopenic purpura (TTP) and hematopoietic stem cell transplant (HSCT)-related TMA. The trial has fully enrolled the first and second cohorts and is currently completing the third and final planned cohort of its dose-ranging stage. In each three-patient cohort, OMS721 is dosed for four weeks. Three patients were treated in the second or mid-dose cohort, two of whom have aHUS and one with TTP. Both patients with aHUS were on renal dialysis prior to and at the time of study enrollment. Based on the positive data from the mid-dose cohort, the high-dose cohort was initiated and an aHUS patient has already completed the study treatment period. No patient with HSCT-related TMA has yet completed dosing with OMS721. The data referenced for all patients include measures to one week following the last dose. TMAs are characterized by thrombi or clumps of aggregated platelets in small blood vessels, which lead to thrombocytopenia (below-normal platelet counts) and schistocytes (fragmentation in red blood cells) that can cause dangerously low oxygen levels in organs like the brain and kidney as well as anemia. Thrombotic microangiopathies are life-threatening and can occur both in children and adults. While thrombi, thrombocytopenia and schistocytes are hallmarks of TMAs, other markers of damage within the blood vessels include an elevated plasma lactate dehydrogenase (LDH) and undetectable or reduced plasma haptoglobin levels. In addition, an elevated creatinine level 'a result of the kidney damage caused by thrombi' is an indicator of impaired kidney function in patients who are not on renal dialysis. In the mid-dose cohort, the two patients with plasma therapy-resistant aHUS demonstrated: 47% increase in mean platelet count, resulting in both patients having counts in the normal range; 86% decrease in mean schistocyte count, with schistocytes disappearing in one patient; 71% increase in mean haptoglobin with both patients reaching the normal range during treatment, one slipping slightly below normal at one week following the last dose; and 5% decrease in the mean levels of LDH, with levels in both patients remaining slightly elevated above normal range. The mid-dose-cohort patient with TTP required repeated plasma infusion therapy prior to entering the study. Laboratory parameters did not show consistent improvement, but the patient did not require plasma therapy during treatment with OMS721 and, to date, has not required it since completing treatment. The first patient in the high-dose cohort 'a plasma therapy-resistant aHUS patient with additional complicating disorders including hepatitis C, cryoglobulinemia and lymphoma' has also completed treatment with OMS721. Prior to OMS721 treatment, the patient required repeated dialysis. Throughout treatment and following completion of the OMS721 course, the patient to date has remained off dialysis. Hematological and renal parameters showed: 63% improvement in platelet count, returning to normal levels; 100% decrease in schistocytes; Haptoglobin increased from an undetectable level and normalized; 43% decrease in LDH, resulting in a level just slightly above normal; and 24% reduction in creatinine level. As expected, patients with aHUS in the mid- and high-dose cohorts demonstrated more consistent and robust improvement in efficacy measures than patients in the low-dose cohort. As in the low-dose cohort, the drug was well tolerated by all patients in the mid- and high-dose cohorts throughout the treatment period. There have been no confirmed clinically meaningful drug-related adverse events in any clinical trials with OMS721. To date, two clinically meaningful adverse events were considered possibly related to OMS721 when first observed because an infectious etiology could not be ruled out at diagnosis, but all cultures subsequently proved negative. Specifically, one patient in the low-dose cohort was reported as possibly having an infection; however, all cultures were negative and no infection was identified. Another patient had significant diarrhea, but all tests for gastrointestinal pathogens were negative and the patient was receiving immunosuppressive therapy, including a drug very commonly associated with diarrhea. In addition, animal chronic toxicity studies have been completed and no notable adverse findings were observed. The FDA has cleared OMS721 for chronic dosing in clinical trials. Physician-requested compassionate use is ongoing, and all patients in the compassionate-use program are reported by their physicians to be doing well.