Eye Drug Omidria (Phenylephrine/Ketorolac) Gets FDA Nod
U.S. launch expected by early fall 2014
The FDA has approved Omidria (phenylephrine and ketorolac injection, 1.0%/0.3%, Omeros Corporation) for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis and to reduce postoperative pain.
The approval comes with no postmarketing commitments other than a previously agreed study of Omidria in pediatric patients, which, if successfully completed, will make the drug eligible for an additional 6 months of marketing exclusivity in the U.S.
Omidria is a proprietary combination of a mydriatic agent (phenylephrine) and an anti-inflammatory agent (ketorolac) that is added to irrigation solution customarily used during cataract surgery and other ILR procedures (e.g., refractive lens exchange) — collectively the most common surgical procedures performed in the U.S. at nearly four million annually.
Omidria is the only FDA-approved product for intraocular use that prevents intraoperative miosis and reduces postoperative pain.
In pivotal clinical trials in which all patients received standard pupil-dilating and anesthetic agents before surgery, Omidria demonstrated a statistically significant improvement in the prevention of miosis and in the reduction of postoperative pain compared with placebo. Ocular adverse events were similar between the Omidria and placebo groups and included eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation.
The U.S. launch is expected to take place in summer or early fall 2014.
Source: Omeros Corp.; June 2, 2014.