SEATTLE--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER) today announced that the results of four studies directed to the benefits of OMIDRIA across a range of clinical situations in cataract surgery will be presented at the upcoming American Society of Cataract and Refractive Surgery (ASCRS) Congress in Washington, D.C., April 13-17, 2018.
The four presentations are scheduled as follows:
Saturday, April 14: 1:41 PM – 1:46 PM
Walter E. Washington
Convention Center – Room 143A
Miosis Prevention in
Femtosecond-Assisted Cataract Surgery Using a Continuous Infusion of
Phenylephrine and Ketorolac. Walter K, Delwadia N
Monday, April 16: 1:29 PM – 1:34 PM
Walter E. Washington Convention
Center – Room 143B
Effect of Early Phenylephrine and
Ketorolac Injection 1%/0.3% on Pupil Diameter in Traditional and
Femtosecond-Assisted Cataract Surgery. Gayton J.
Monday, April 16: 2:08 PM – 2:13 PM
Walter E. Washington Convention
Center – Room 143B
Effect of Phenylephrine and Ketorolac
Injection on Intraoperative Floppy Iris Syndrome. Silverstein
S., Rana V.
Monday, April 16: 2:13 PM – 2:18 PM
Walter E. Washington Convention
Center – Room 143B
Clinical Outcomes of
Phenylephrine/Ketorolac (1%/0.3%) vs. Epinephrine in Cataract Surgery in
a Real-World Setting. Matossian C.
About OMIDRIA®
Omeros’ OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is the first and only FDA-approved product of its kind and is marketed in the U.S. for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. OMIDRIA also is the only NSAID-containing product FDA-approved for intraocular use. In post-launch studies across conventional and femtosecond laser-assisted cataract surgery, OMIDRIA has been shown (1) to be effective in patients with intraoperative floppy iris syndrome (IFIS), pseudoexfoliation and other ophthalmic conditions, (2) to significantly reduce complication rates, use of pupil-expanding devices, and surgical times, and (3) to significantly improve uncorrected visual acuity on the first day following cataract surgery. While OMIDRIA is broadly indicated for use in cataract surgery, the above outcomes are not in its currently approved labeling. Surgical time was not an endpoint in the OMIDRIA Phase 3 clinical trials and did not reach statistical significance in post hoc analysis of the Phase 3 data.
Important Safety 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 percent or greater 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.
About Omeros Corporation
In addition to Omeros’ commercial drug OMIDRIA, Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
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,” “likely,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements are based on management’s 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 and commercial operations, 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 company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2018. 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.
