Navigation Links
Omeros Submits OMS302 Marketing Authorization Application to European Medicines Agency
Date:9/10/2013

SEATTLE, Sept. 10, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market OMS302 for use in patients undergoing intraocular lens replacement (ILR) surgery in the European Union (EU). Added to standard irrigation solution used during ILR, OMS302 is Omeros' proprietary PharmacoSurgery® product that, across multiple human trials, demonstrated clinically meaningful and statistically significant maintenance of intraoperative mydriasis (pupil dilation), prevention of intraoperative miosis (pupil constriction), and reduction of postoperative ocular pain.

With the submission by Omeros of a New Drug Application (NDA) for OMS302 to the U.S. Food and Drug Administration (FDA) in July 2013, the MAA represents Omeros' second major submission seeking regulatory authorization to market OMS302. The EMA previously granted OMS302 eligibility for centralized review, determining that the product represents a significant therapeutic innovation. The MAA for OMS302, therefore, was submitted through EMA's Centralized Procedure, which allows submission of a single application that, when approved, authorizes the drug to be marketed in all EU member states and European Free Trade Association countries rather than requiring separate national approvals. The NDA and MAA are each subject to an initial evaluation prior to commencement of the formal review process. Assuming successful completion of the review process and approval of the NDA and MAA, OMS302 is expected to be available to ophthalmic surgeons and their patients in the U.S. and Europe in the second half of 2014.

"Having submitted two major marketing applications just weeks apart for our lead product is an outstanding achievement," said Gregory A. Demopulos, M.D., chairman a
'/>"/>

SOURCE Omeros Corporation
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Omeros to Present at Deutsche Bank Securities Health Care Conference
2. Omeros Adds Four More Unlocked Orphan GPCRs to its Portfolio
3. Omeros to Present at Jefferies 2012 Global Healthcare Conference
4. Omeros Announces Proposed Public Offering of Common Stock
5. Omeros Prices $30 Million Public Offering of Common Stock
6. Omeros Announces Closing of $34.5 Million Public Offering of Common Stock
7. Omeros Successfully Completes Preclinical Studies of OMS824 for Schizophrenia and Phase 1 Clinical Trial Preparations Underway
8. Omeros Announces Discovery in MASP-2 Program
9. Omeros Corporation Reports Second Quarter 2012 Financial Results
10. Omeros Announces Completion of Enrollment in OMS103HP Phase 3 Clinical Trial
11. Omeros to Present at Two Upcoming Conferences
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2015)... 2015 The North American dental lasers ... estimated to reach $90.7 million by 2019, at a CAGR ... the TOC of North America Dental Lasers Market for an ... various tables and figures. http://www.micromarketmonitor.com/market/north-america-dental-lasers-1771208223.html ... report.   Dental lasers are specifically used ...
(Date:5/22/2015)... NEW YORK and KING OF PRUSSIA, ... Hemophilia Foundation (NHF) has awarded CSL Behring ... longstanding and unwavering commitment to advancing science and improving the ... by Paul Perreault , CEO and Managing Director, CSL ... New York City on May 21. ...
(Date:5/22/2015)... , May 22, 2015 According ... Market by Product (Consumables, Instruments, Services), by Test Type ... Chromatography, Flow Cytometry), by End Users - Global Forecast ... Market is expected to reach $736.85 Million by 2020 ... of 10.25%. Browse 71 market data ...
Breaking Medicine Technology:North America Dental Lasers Market is Expected to Reach $90.7 Million by 2019, at a CAGR of 9.2% From 2014 to 2019 2North America Dental Lasers Market is Expected to Reach $90.7 Million by 2019, at a CAGR of 9.2% From 2014 to 2019 3National Hemophilia Foundation Honors CSL Behring with Corporate Leadership Award 2National Hemophilia Foundation Honors CSL Behring with Corporate Leadership Award 3National Hemophilia Foundation Honors CSL Behring with Corporate Leadership Award 4Oxidative Stress Assays Market Worth $736.85 Million by 2020 2Oxidative Stress Assays Market Worth $736.85 Million by 2020 3Oxidative Stress Assays Market Worth $736.85 Million by 2020 4
... 2011 Pharmaceutical Care Management Association (PCMA) President and ... Florida Governor Rick Scott,s Medicaid savings proposal: ... spending in Medicaid, which is a big problem when ... ,fee-for-service, approach, Florida Medicaid pays drugstores much more than ...
... 8, 2011 Dynatronics Corporation (Nasdaq: DYNT ) ... months ended December 31, 2010 during the morning of Monday, ... conference call for investors later that day at 1:30 p.m. ... in participating should call (800) 926-7431 and use access code: ...
Cached Medicine Technology:
(Date:5/24/2015)... May 24, 2015 EnviroLeather™ by ... “InkGard™ Plus” – a classic, rugged leather grain ... allowing difficult stains, including ink, to be easily ... colors suitable for corporate, healthcare, hospitality and education ... with EnviroLeather’s goal of developing products that are ...
(Date:5/24/2015)... (PRWEB) May 24, 2015 ... System CEO - The students ... honored at the fourth annual A ... 15 at Geneva National in Lake ... ,     -Badger High School,         Jonathan Alfonso, ...
(Date:5/23/2015)... CA (PRWEB) May 23, 2015 With ... small businesses, are finding it increasingly difficult to provide ... which fail to provide adequate insurance for employees stand ... businesses been such an integral part of a business’s ... affordable healthcare for businesses, Online USA Doctors has created ...
(Date:5/23/2015)... (PRWEB) May 23, 2015 Javon ... at the Sports Medicine and Rehabilitation Center, 557 N. ... program, Mondays, June 1-July 20, 5:30-6:30 pm. , The ... coach, and Laurie Finke, RN, BSN, who will offer ... education on nutrition, running mechanics and show selection and ...
(Date:5/22/2015)... May 22, 2015 The American College ... events in June. They will hold a webinar on ... a two-day class on Classical Chinese Medicine. , Webinar ... Dr. Steve Given, the Dean of Clinical Education, will ... new First Professional Doctorate program. ACTCM is currently developing ...
Breaking Medicine News(10 mins):Health News:EnviroLeather By LDI Launches "InkGard Plus" - Stain Resistant Faux Leather 2Health News:Mercy Foundation Honors 16 Students for Making a Difference - Mercy Health System Javon Bea 2Health News:Online USA Doctors Now Offers Cost-Saving Alternative Healthcare for Businesses 2Health News:Online USA Doctors Now Offers Cost-Saving Alternative Healthcare for Businesses 3Health News:ACTCM Announces Upcoming June Events 2
... who lost her husband to AIDS and is now diagnosed with ... Devi, 40, from Tilaei village in Rohtas district, ended her life ... her husband Sunil Mahto died of AIDS. ,"She was ... treated her after her husband's death," said a villager Nagender Singh. ...
... sold in shops would indicate maximum retail prices (MRP) ... was taken in a meeting of the committee, which ... steel. The members were discussing the draft national pharmaceutical ... 354 drugs in the national list of essential medicines ...
... sex determination test kits to counter online threats to its ... Mentor Home DNA gender testing kit' for $275 promising results ... of unborn girls in Punjab, Haryana and Delhi. ... Punjab's Health Minister Ramesh Chander Dogra told a news channel ...
... the University of Rochester when investigating for an alternative ... flashes as good as estrogen. ,Gabapentin, a ... of calcium in and out of the cells, which ... like was researchers, who have been investigating new therapies ...
... researcher Daniel Kahneman, PhD, and colleagues have come to ... wealth brings happiness//. Kahneman shared the 2002 Nobel Prize ... ,As Kahneman and colleagues have observed in their ... "When someone reflects on how additional income would change ...
... New Zealand is close to making it mandatory for food ... birth defects//. , ,The organisation that monitors food standards ... the proposal by next month. ,Many live ... by neural tube defects such as spina bifida, where one ...
Cached Medicine News:Health News:Gabapentin Reduced Menopausal Symptoms as Estrogen – Study Find 2Health News:Money Cannot Buy Happiness 2Health News:NZ To Opt For Folate Fortification Of Bread 2
... Another first for Linvatec! The EnVision ... experience and proprietary technology to ensure ... Linvatecs Shockflex prism system gives our ... protect their investment. With an integrated ...
... customized digital camera offers maximum ... video needs. With internal video ... to best meet your specific ... are interchangeable with autoclavable and ...
... 1-Chip Camera System provides easy-to-use features, auto ... scope. The camera head construction is based ... 14, Complete 1-Chip Camera System, International (GS ... Unit (CCU) with video cables , (GS ...
... 1-Chip Camera System provides easy-to-use features, auto ... scope. The camera head construction is based ... 12, Complete 1-Chip Camera System, International (GS9900-PAL) ... (CCU) with power cord and video cables ...
Medicine Products: