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Omeros Corp.


Omeros Corp. is a clinical-stage biopharmaceutical company discovering, developing and commercializing small-molecule and protein therapeutics targeting inflammation, coagulopathies and disorders of the central nervous system. Lead drug product Omidria (OMS302) for lens replacement surgery is under review for marketing approval by both FDA and the European Medicines Agency, with U.S. commercial launch planned for H2/14. Omeros' five other clinical programs are focused on schizophrenia; Huntington's disease and cognitive impairment; addictive and compulsive disorders; complement-related diseases; and preventing problems associated with surgical procedures. Omeros' proprietary G protein-coupled receptor (GPCR) platform is making available many new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.

The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.

Expert Comments:

The Life Sciences Report Interview with Steve Brozak (11/13/14) "Omeros Corp.'s product, Omidria (phenylephrine + ketorolac), was approved on May 30 of this year. Omidria is a simple combination of two older drugs that have been in the public domain for quite some time. One is a mydriatic or pupil-dilating agent, and the other is an anti-inflammatory and analgesic. The product was designed for use in cataract and intraocular lens replacement surgery, and it results in patients having less post-operative pain. The company will start selling Omidria on Jan. 1, 2015, and just recently, on Oct. 30, the product received pass-through reimbursement approval from the Center for Medicare & Medicaid Services. Now Omidria can be reimbursed by Medicare, Medicaid and many private insurers beyond the cost of the surgical procedure itself. Omeros' reimbursement will be based on the product's wholesale acquisition cost of $465 per single-use vial, which would cover a single procedure. . . .instead of having to use compounded products or homebrews to do lens surgery, the surgeon can now use a product that is FDA-approved, proven sterile and safe, and reimbursable by payers. Physicians should be using it as standard of care. I don't think there is an obstacle to adoption of Omidria at this point." More >

The Life Sciences Report Interview with George Zavoico (11/12/14) "I think Omeros Corp. is on the cusp of an inflection point. At the end of May, the company's Omidria (phenylephrine + ketorolac) irrigation solution for intraocular lens replacement surgery was approved. . .Omidria should have a big effect on this very large market. One of the important issues for investors is that Omeros is likely to be marketing Omidria itself, which is prudent since the company can focus on centers that do a lot of these procedures. It won't need a huge sales force. . .the benefit is that Omeros collects all the revenue, and doesn't have to share the profit. . .recently Omeros got a very favorable decision from the Centers for Medicare and Medicaid Services (CMS) on reimbursement. The company requested, and received, pass-through reimbursement status, effective Jan. 1, 2015, which means that Omidria's cost will not be bundled with the reimbursement for an intraocular replacement surgery procedure. Omeros is guiding to a launch early next year, just as the pass-through status becomes effective. . .we'll be watching the quarterly sales revenue numbers to better gauge market penetration. . .we see a pretty healthy revenue stream coming from Omidria. . ." More >

The Life Sciences Report Biotech Watchlist Update with George Zavoico (11/6/14) "We believe Omeros Corp.'s Omidria will have a successful launch and become widely used by ophthalmic surgeons and that Omeros will become profitable in 2016. . .key catalysts with Omidria will be the success of the launch and growth in sales revenue from quarter to quarter. . .[while Omidria] by itself is enough to keep a company busy and prosperous, we think that Omeros' diverse and promising drug pipeline has even more potential." More >

Jason Kolbert, Maxim Group (11/3/14) "Omeros Corp.'s Omidria has been approved, and we currently assume OMS302 (intraocular lens replacement surgery) will see a full launch in late Q4/14. . .we believe global sales could reach north of $30M by 2017 for OMS302."

Jason Kolbert, Maxim Group (10/22/14) "Omeros Corp. self-imposed a temporary suspension of OMS824 Huntington's disease trial. . .what does this mean? Likely not much, but we are confident that the right call is being made by Omeros to temporarily suspend the current Phase 2 trial to be cautious. Omeros has had communications with the FDA and it agreed that Omeros should sort out the preclinical data."

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George Zavoico, MLV & Co (10/22/14) "Yesterday, Omeros Corp. announced enrollment suspension of a Phase 2 trial of OMS824 for he treatment of Huntington's disease due to higher-than-expected free-plasma drug concentrations seein in a parallel non-clinical study in rats. . .we continue to believe OMS824 to be safe. . .and expect the Phase 2 trial to resume after this issue is resolved, we think within a few months. We reiterate our Buy recommendation."

The Life Sciences Report interview with Liana Moussatos (8/21/14) "Omeros Corp.'s drug Omidria (phenylephrine + ketorolac) [was] approved on May 30 for cataract and other intraocular lens replacement surgeries. The company announced the approval on June 2. A lot of fast money sold on the catalyst, but just a few days later Omeros started rising. That's because the longer-term investors had done their homework, had gotten comfortable with the market potential of Omidria, and had started buying the stock. . .

There's more to Omeros than Omidria. The company has quite a pipeline. It has two significant Phase 2 trials that will provide data around the end of this year. One is the company's human monoclonal antibody OMS721 for thrombotic microangiopathies. . .Omeros' other pipeline drug is OMS824, a phosphodiesterase 10 inhibitor for Huntington's disease. . .I think the Phase 2 data from either one of these trials could solidify Omeros. . . More >

Mick Cooper, Edison Investment Research (7/3/14) "The FDA's approval of Omeros Corp.'s Omidria on May 30, 2014, for use during cataract surgery or lens replacement will start the U.S. launch process in late summer/early autumn of 2014. . .anticipation of a good price point at launch and EU approval (with potential for an EU partnering deal) would maintain momentum through 2014. . .importantly, the use of Omidria does not require major changes to operating procedures and there is no other product on the market that combines a mydriatic agent (pupil dilator) and an NSAID for pain relief."

The Life Sciences Report Interview with Jason Kolbert (6/4/14) "I really like following Omeros Corp. It is a specialty pharma coupled with a true biotech company, and is working on a couple of exciting products. Dr. Greg Demopulos, the CEO, is an orthopedic surgeon—he's brilliant.

Omeros has just received approval of Omidria (OMS302; phenylephrine + ketorolac), which was developed for intraocular lens (IOL) replacement. We think Omidria can be reasonably successful. It allows the ophthalmic surgeon to retain both a dilated surgical field as well as reduce the inflammation and pain associated with the surgery. It provides a convenience factor and a better outcome for what tends to be an elective procedure. There is the potential for Omidria to be a couple-hundred-million-dollar product, and to build free cash flow for the company. That would fund the development of Omeros' pipeline. . ." More >

Jason Kolbert, Maxim Group (6/2/14) "Omeros Corp. announced this morning that OMS302, or Omidria, has been approved. We currently assume OMS302 (intraocular lens replacement surgery) will see a full launch in Q4/14 with some sales beginning in Q3/14. . .we believe global sales could reach north of $300M by 2017 for OMS302."

Jason Kolbert, Maxim Group (5/20/14) "Omeros Corp. recently announced positive data using OMS721, the lead human monoclonal antibody in the company's mannan-binding lectin-associated serine protease-2 program. . .we believe investors should pay close attention to this program in light of the success of Alexion Pharmaceuticals Inc.'s eculizumab (Soliris), which is an anti-C5 monoclonal antibody that is approved by the U.S. Food and Drug Administration and the European Medicines Agency to treat patients with atypical hemolytic uremic syndrome."

Jason Kolbert, Maxim Group (3/11/14) "Omeros Corp. announced positive data using OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 (MASP-2) program. . .the data suggests that OMS721 significantly inhibited complement deposition in the model using serum samples from aHUS patients obtained during the acute phase of disease. . .the potential of the Omeros MASP-2 antibody is significant, in our opinion. MASP-2 is the only protein unique to, and required for, the function of the lectin complement pathway."

The Life Sciences Report Interview with George Zavoico (3/6/14) "Omeros [has] a number of features that I find interesting. First is the near-term approval of a niche product called Omidria, [an] irrigant for use in intraocular lens replacement surgery to reduce inflammation and postoperative pain. . . we think this is a low-cost, high margin and volume product that could generate about $100M in sales in 2016. . .possibly enough to bring Omeros to profitability that same year. . .

The new drug application for Omidria was filed back in the summer, and after that a marketing authorization application was filed with the European Medicines Agency. . .we expect a decision after the standard 10-month review—probably midyear or early Q3/14 for the FDA—with launch sometime before the end of 2014.

Behind Omidria, there's a robust pipeline that the company has advanced into a number of phase 1 and phase 2 trials. These are unique products that could be first-in-class for a number of interesting indications, including some central nervous system and inflammatory indications." More >

The Life Sciences Report Interview with Steve Brozak (2/6/14) "Omeros Corp. has a therapy platform that targets inflammation, whether it be ophthalmic or in joints, specifically in arthroscopic surgery. The idea is to reduce inflammation, thereby reducing postoperative pain and providing for much better outcomes. . .I think it would be easy for Omeros to single-handedly take the market." More >

Jason Kolbert, Maxim Group (2/5/14) "Omeros Corp.'s pipeline progress looks good: The company announced that the FDA granted fast-track designation to OMS824, the company's phosphodiesterase 10 inhibitor, for the treatment of cognitive impairment in patients with Huntington's disease. . .Omeros has conducted successful clinical trials assessing the safety, tolerability, pharmacokinetics and target engagement of a wide range of doses of OMS824 in its phase 1 program. Positive data from the company's OMS824 phase 2a schizophrenia trial were recently announced, and Omeros expects to begin enrolling patients this quarter in its phase 2 trial evaluating OMS824 for Huntington's disease."

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