Disclosure of Omidria Post-Launch Study Findings to Occur at Hawaiian Eye and Retina Conference
- reduction in complications associated with small pupils;
- reduction in usage of pupil-expanding devices;
- prevention of miosis during femtosecond laser-assisted surgery;
- reduction in age-adjusted surgical times; and
- 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.
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
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.
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 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 including with respect to Omidria® and
OMS103, Omeros’ ability to partner and commercialize Omidria®
View source version on businesswire.com: http://www.businesswire.com/news/home/20160115005962/en/
Cook Williams Communications, Inc.
Jennifer Cook Williams, 360-668-3701
Investor and Media Relations