OMIDRIA®(phenylephrine and ketorolac intraocular solution) 1%/0.3% is marketed in the U.S. for use during cataract surgery or intraocular (IOL) replacement to maintain pupil size by preventing intraoperative miosis and to reduce postoperative ocular pain. OMIDRIA is a proprietary combination of a mydriatic (pupil-dilating) agent and a non-steroidal anti-inflammatory agent that is added to irrigation solution standardly used during cataract surgery and other IOL procedures (e.g., refractive lens exchange).
In pivotal trials in which all patients received standard pupil-dilating and anesthetic agents prior to surgery, OMIDRIA demonstrated statistically significant and clinically meaningful improvement in the prevention of miosis and reduction of postoperative pain relative to placebo. Adverse reactions in the trials were similar between the OMIDRIA and placebo groups and included eye irritation, posterior capsule opacification, increased intraocular pressure and anterior chamber inflammation.
OMIDRIA was launched in the U.S. in the second quarter of 2015 for use during cataract surgery or IOL replacement. In the European Union, the European Commission (EC) has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. For more information about OMIDRIA, see www.omidria.com.
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.
About Cataract Surgery and Intraocular Lens Replacement
Cataract surgery and other IOL replacement procedures involve replacement of the original or artificial intraocular lens of the eye with a new artificial lens. These procedures are typically performed to replace a lens opacified by a cataract or to correct a refractive error of the lens (i.e., refractive lens exchange). Because intraoperative pupil constriction (miosis) increases the risk of injury to intraocular structures and can substantially prolong surgical time, maintenance of pupil dilation (mydriasis) is critical to the safety and surgical ease of the procedure.
OMIDRIA is encompassed by our PharmacoSurgery patent portfolio. The relevant patents and patent applications in this portfolio are directed to combinations of agents, generic and/or proprietary to us or to others, drawn from therapeutic classes such as pain and inflammation inhibitory agents, mydriatic agents and agents that reduce intraocular pressure, delivered locally and intraoperatively to the site of ophthalmological procedures, including cataract and lens replacement surgery. As of February 16, 2018, we owned seven issued U.S. patents and three pending U.S. patent applications and 57 issued patents and 60 pending patent applications in foreign markets that are directed to OMIDRIA.