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.

Expert Comments:

"Omeros Corp. just received Centers for Medicare and Medicaid Services reimbursement approval for Omidria, its first FDA-approved drug. The company actually received better pricing than the Street had anticipated. . .with Omeros' product, surgeons will receive a better product from a single-source, FDA-regulated company." read more >

"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." read more >

"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. . ." read more >

"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." read 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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