Omeros Corporation (NASDAQ:OMER), a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, announced that it has completed enrollment in the post-marketing pediatric clinical trial that is expected to provide extended market exclusivity of its commercial product OMIDRIA® (phenylephrine and ketorolac) 1% / 0.3%. The FDA has approved OMIDRIA for use in adult patients undergoing cataract or intraocular lens replacement surgery to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain.
Successful completion of the pediatric clinical trial by the company results in eligibility for an additional 6 months of marketing exclusivity for OMIDRIA. An FDA post-marketing requirement, the pediatric clinical trial of OMIDRIA enrolled patients 0-3 years of age undergoing cataract surgery. Successful completion of the trial requires compliance with FDA clinical trial regulations and meeting pre-specified timelines. The trial is being conducted in compliance with FDA regulations and within the specified timelines. Similar to the Phase 3 clinical program, efficacy assessments include pupil diameter and pain. OMIDRIA is not yet approved for use in patients less than 18 years of age, and the trial will provide clinical information on the use of OMIDRIA in the pediatric population. Cataracts are relatively rare in the pediatric population, and the sample size was selected to enable identification of potential safety issues in the pediatric population. Consistent with FDA’s request, over 70 patients were enrolled and treated.
“We would like to thank the patients together with their parents and families for their participation in this trial, and we greatly appreciate the efforts of the investigators and other clinical site personnel,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “We expect that the trial results will provide important information on the role of OMIDRIA in pediatric patients and look forward to submitting the data to FDA to meet the criteria required for additional marketing exclusivity.” (Original Source)
Shares of Omeros closed yesterday at $10.24, up $0.71 or 7.45%. OMER has a 1-year high of $30.23 and a 1-year low of $8.90. The stock’s 50-day moving average is $10.92 and its 200-day moving average is $12.49.
On the ratings front, Omeros has been the subject of a number of recent research reports. In a report issued on June 14, WBB analyst Stephen Brozak maintained a Buy rating on OMER, with a price target of $75, which represents a potential upside of 632.4% from where the stock is currently trading. Separately, on June 3, Maxim Group’s Jason Kolbert initiated coverage with a Buy rating on the stock and has a price target of $21.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Stephen Brozak and Jason Kolbert have a total average return of 8.8% and -16.8% respectively. Brozak has a success rate of 34.5% and is ranked #732 out of 3980 analysts, while Kolbert has a success rate of 28.8% and is ranked #3879.
Omeros Corp. is a clinical stage biopharmaceutical company, which engages in the discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system. Its products are derived from its proprietary PharmacoSurgery platform designed to improve clinical outcomes of patients undergoing arthroscopic, ophthalmological, urological and other surgical and medical procedures. The company also has a deep and diverse pipeline of preclinical programs as well as a platform capable of unlocking new drug targets. Omeros was founded by Gregory A. Demopulos and Pamela Pierce Palmer on June 16, 1994 and is headquartered in Seattle, WA.