Navigation Links
Omeros Ophthalmology Product OMS302 Granted Eligibility for European Centralized Review
Date:4/30/2013

SEATTLE, April 30, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the European Medicines Agency (EMA) has confirmed that the Company's planned Marketing Authorization Application (MAA) for its ophthalmology product OMS302 can be submitted and reviewed under the EMA's centralized procedure. OMS302, which contains mydriatic (pupil-dilating) and anti-inflammatory agents, is the Company's product being developed for use during intraocular lens replacement, including cataract surgery and refractive lens exchange. EMA's Committee for Medicinal Products for Human Use granted this eligibility for OMS302 because it represents a significant therapeutic innovation.

The EMA's centralized procedure allows submission of a single MAA that, when approved, authorizes the drug to be marketed in all European Union member states and European Free Trade Association countries rather than requiring separate national approvals. The centralized process can significantly accelerate widespread commercialization in Europe. Omeros intends to submit a New Drug Application for OMS302 to the U.S. Food and Drug Administration this quarter and an MAA to European regulators in mid-2013.

"The determination that OMS302 qualifies for centralized filing underscores the product's therapeutic innovation and allows Omeros to pursue more rapid commercialization throughout Europe," stated Gregory A. Demopulos , M.D., chairman and chief executive officer of Omeros. "OMS302 promises significant benefits to ophthalmic surgeons and their patients, and we look forward to launching it in the U.S. and Europe next year." 

About Omeros' OMS302 Program
OMS302 is Omeros' product being developed for use during intraocular lens replacement (
'/>"/>

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

Page: 1 2 3

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:4/24/2015)... , April 24, 2015  Bayer Corporation hosted its annual ... at the Bayer HealthCare US headquarters.  This is Bayer,s second ... Whippany campus, and Thursday,s event welcomed ... every day at work. Fortunately, for the kids, ... a company whose mission is "Science For A Better Life," ...
(Date:4/24/2015)... , April 24, 2015  New technologies and ... consumers to educate themselves about products and companies. ... and techniques available to market researchers seeking insights ... consumer marketplace, it,s imperative that organizations adjust their ... identify market opportunities, niches and growth fronts. ...
(Date:4/24/2015)... , April 24, 2015  Span-America Medical ... to release its fiscal 2015 second quarter results ... trading. The company will conduct a ... May 1, to review the company,s financial and operating ... A live broadcast of the conference call will ...
Breaking Medicine Technology:Bayer Hosts "Take Your Child to Work Day" 2Bayer Hosts "Take Your Child to Work Day" 3Bayer Hosts "Take Your Child to Work Day" 4Pharmaceutical Industry Using New Technologies to Adjust Their Marketing and Research Approaches for Consumers 2
(Date:4/25/2015)... 2015 Gardant Management Solutions will ... and operations, and sales and marketing at the ... to be held from April 29 through May ... the largest eldercare association in Illinois. The statewide ... older adults, including senior housing, assisted living and ...
(Date:4/25/2015)... Sports controversies continue to revolve around issues of abuse and ... with the Miami Dolphins and Richie Incognito, or off the field ... domestic abuse case. In a recent episode of SCI TV ... of locker room culture on teams. He examines what worked for ... to improve the locker room as a work place. , ...
(Date:4/24/2015)... Bird B Gone, the leader in bird ... a complete line of bird control solutions to address the ... Flu Strains Threaten Pacific, Central and Mississippi Farms , According ... a number of highly pathogenic avian flus in the Pacific, ... spread when wild birds enter poultry farms. The USDA urges ...
(Date:4/24/2015)... April 24, 2015 As the nation ... the unique sacrifices of these young men and women, ... members, Veterans and their Families” presents a special training ... designed to gain a better understanding of the effect ... wellness. For those – civilian and military – who ...
(Date:4/24/2015)... April 24, 2015 The Fastest Fat Loss ... their great success of the Xtreme Fat Loss Diet, has ... The fat loss blueprint that claims to help one lose ... of HealthyandFitZone.com's Stan Stevenson, prompting an investigative review. , "Our ... the creators spent years researching and experimenting with these methods ...
Breaking Medicine News(10 mins):Health News:Gardant Management Solutions Staff Shares Operational Expertise 2Health News:David Steele Discusses Locker Room Culture on SCI TV 2Health News:David Steele Discusses Locker Room Culture on SCI TV 3Health News:Bird B Gone Offers Solutions to Bird Flu Threat to Poultry Farms 2Health News:Bird B Gone Offers Solutions to Bird Flu Threat to Poultry Farms 3Health News:Bird B Gone Offers Solutions to Bird Flu Threat to Poultry Farms 4Health News:Coalition Presents Resiliency Training to Raise Awareness during Month of the Military Child (#MOTMC2015) 2Health News:Fastest Fat Loss Week Ever Review Revealed on Healthy & Fit Zone 2
... & Orthopedic Hospital,of Chicago (NOHC) is among the top five ... Annual HealthGrades Hospital Quality in,America study. The HealthGrades Research analyzed ... three years. The study also,concluded that NOHC is:, ... -- A recipient of the HealthGrades Spine Surgery ...
... Facility is First New Maine Hospital in ... Global Med Technologies(R),Inc. (OTC Bulletin Board: GLOB), ... today that its Wyndgate,Technologies(R) division has signed ... of Brunswick, Maine, to license its SafeTrace ...
... delivers patient support ... BATESVILLE, Ind., March 6 Hill-Rom ... incorporate,NanoHorizon,s antimicrobial technology into Hill-Rom,s patient support,surfaces. ... (TM) with,SmartSilver(TM)", will bring new levels of ...
... A new guideline on colorectal cancer screening ... broad spectrum of health care organizations, including the ... for Gastrointestinal Endoscopy (ASGE) and the American Cancer ... colorectal cancer detection and states a strong preference ...
... Center in Bethesda, Maryland Coincides, With Sleep Apnea Awareness Day ... ... Awareness Week, DALLAS, March 6 /PRNewswire/ - The observance of Sleep ... Keith Thornton,third-generation Dallas dentist and recognized expert on the treatment of,sleep disordered ...
... Centers, Inc.,("GNC" or the "Company"), the largest global ... results for the,quarter and year ended Dec. 31, ... indirect wholly-owned subsidiary,of GNC Parent LLC, which was ... Management LLC and Ontario Teachers, Pension Plan Board. ...
Cached Medicine News:Health News:Neurologic & Orthopedic Hospital of Chicago Ranked Among Top in Nation for Spine Surgery 2Health News:Newest Hospital in New England Signs Agreement With Global Med Technologies(R), Inc. 2Health News:Newest Hospital in New England Signs Agreement With Global Med Technologies(R), Inc. 3Health News:Hill-Rom Selects NanoHorizons to Provide Antimicrobial Protection for Hill-Rom Products Using Nanotechnology 2Health News:Hill-Rom Selects NanoHorizons to Provide Antimicrobial Protection for Hill-Rom Products Using Nanotechnology 3Health News:Hill-Rom Selects NanoHorizons to Provide Antimicrobial Protection for Hill-Rom Products Using Nanotechnology 4Health News:Hill-Rom Selects NanoHorizons to Provide Antimicrobial Protection for Hill-Rom Products Using Nanotechnology 5Health News:New guidelines update recommendations on colorectal cancer screening 2Health News:New guidelines update recommendations on colorectal cancer screening 3Health News:New guidelines update recommendations on colorectal cancer screening 4Health News:Dallas Dentist Trains Navy Dentists on New Therapy to Treat Snoring and Obstructive Sleep Apnea 2Health News:General Nutrition Centers, Inc. Reports Fourth Quarter and Full Year 2007 Results 2Health News:General Nutrition Centers, Inc. Reports Fourth Quarter and Full Year 2007 Results 3Health News:General Nutrition Centers, Inc. Reports Fourth Quarter and Full Year 2007 Results 4Health News:General Nutrition Centers, Inc. Reports Fourth Quarter and Full Year 2007 Results 5Health News:General Nutrition Centers, Inc. Reports Fourth Quarter and Full Year 2007 Results 6Health News:General Nutrition Centers, Inc. Reports Fourth Quarter and Full Year 2007 Results 7Health News:General Nutrition Centers, Inc. Reports Fourth Quarter and Full Year 2007 Results 8Health News:General Nutrition Centers, Inc. Reports Fourth Quarter and Full Year 2007 Results 9Health News:General Nutrition Centers, Inc. Reports Fourth Quarter and Full Year 2007 Results 10Health News:General Nutrition Centers, Inc. Reports Fourth Quarter and Full Year 2007 Results 11
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: