UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 15, 2016
OMEROS CORPORATION
(Exact name of registrant as specified in its charter)
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Washington |
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001-34475 |
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91-1663741 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(IRS Employer
Identification No.) |
201 Elliott Avenue West
Seattle, Washington 98119
(Address of principal executive offices, including zip code)
(206) 676-5000
(Registrants telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
On January 15, 2016, Omeros Corporation issued a press release. A
copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit Number |
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Description |
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99.1 |
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Press release dated January 15, 2016 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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OMEROS CORPORATION |
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By: |
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/s/ Gregory A. Demopulos, M.D. |
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Gregory A. Demopulos, M.D. |
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President, Chief Executive Officer, and Chairman of the Board of Directors |
Date: January 19, 2016
EXHIBIT INDEX
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Exhibit Number |
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Description |
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99.1 |
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Press release dated January 15, 2016 |
Exhibit 99.1
Disclosure of Omidria Post-Launch Study Findings to Occur at Hawaiian Eye and Retina Conference
SEATTLE, WA January 15, 2016 Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and
commercializing small-molecule and protein therapeutics for both large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, today announced that Omidria® (phenylephrine and ketorolac injection) 1% / 0.3% will be the focus of a series of presentations and panel discussions by thought leaders in cataract surgery at Hawaiian Eye and Retina, an annual
conference of over 1,200 ophthalmologists, retina specialists, nurses, allied health professionals and administrators. The first of these presentations and discussions will occur on Sunday, January 17, 2016, at which time certain information
regarding Omidria will be made public. To ensure that developments regarding Omeros business are publicly disseminated to securities markets in consistent fashion, Omeros is announcing that the information to be presented at the conference
includes a summary of investigator-sponsored studies, which have resulted in abstracts and manuscripts accepted, submitted or in preparation, reporting that the use of Omidria across a wide range of patients, including those with non-complex
cataracts, complex cataracts, intraoperative floppy iris syndrome (IFIS) and/or pseudoexfoliation, has resulted in statistically significant:
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reduction in complications associated with small pupils; |
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reduction in usage of pupil-expanding devices; |
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prevention of miosis during femtosecond laser-assisted surgery; |
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reduction in age-adjusted surgical times; and |
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improvement in best corrected visual acuity (BCVA) on the day after surgery. |
The above outcomes are not
referenced in the currently approved labeling for Omidria. Omidria is broadly indicated for use in cataract surgery in adult patients.
The above findings
are from investigator-sponsored, case-controlled/cohort, single-center studies, ranging from approximately 50 to over 1,100 patients, and have not yet been published. Omeros earlier Phase 3 clinical trials evaluating Omidria were not powered
to demonstrate statistical differences in surgical times and BCVA, and results from those Phase 3 trials did not reach statistical significance for those measurements. Complication rates and use of pupil-expanding devices were not assessed in the
Phase 3 trials, and femtosecond laser cases were excluded for purposes of standardization given that not all investigators in the Omidria Phase 3 program used this equipment in cataract surgery. Consistent with publication guidelines, detailed data
from these investigator-sponsored studies will be available in the published abstracts and journal articles.
About Omidria®
Omeros PharmacoSurgery®
product Omidria® contains the mydriatic (pupil-dilating) agent phenylephrine and the anti-inflammatory agent ketorolac and was developed for use during cataract or other IOL replacement
surgery. The FDA has approved Omidria for use during cataract surgery or IOL replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain.
Important Risk Information for Omidria®
Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at
two to 24 percent are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and Omidria-treated patients. Omidria® must be added to irrigation solution prior to intraocular use. Omidria is not approved for use in children.
About Omeros Corporation
Omeros is 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. Derived
from its proprietary PharmacoSurgery® platform, the companys first drug product, Omidria® (phenylephrine and ketorolac injection)
1%/0.3%, has been approved by the FDA for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European
Union, the European Commission (EC) has approved Omidria for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. Omeros has five
clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntingtons disease, schizophrenia, and cognitive impairment; addictive and compulsive disorders; and preventing problems associated with urologic
surgical procedures. In addition, Omeros has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.
Forward-Looking Statements
This press release contains
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the safe harbor created by those sections for such
statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as anticipate, believe, could, estimate, expect,
goal, intend, look forward to, may, plan, potential, predict, project, should, will, would and similar expressions
and variations thereof. Forward-looking statements are based on managements beliefs and assumptions and on information available to management only as of the date of this press release. Omeros actual results could differ materially from
those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with product commercialization including with respect to Omidria® and
OMS103, Omeros ability to partner and commercialize Omidria® in Europe, Omeros unproven preclinical and clinical development activities, regulatory oversight, intellectual property
claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading Risk Factors in the companys Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission
on November 9, 2015. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new
information becomes available in the future.
Contact:
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
360.668.3701
jennifer@cwcomm.org
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