FDA approves Omidria for Cataract surgery - Omeros

The FDA has approved Omidria (phenylephrine and ketorolac injection) 1%/0.3%, from Omeros Corp, for use during Cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative pain. The approval comes with no post-marketing commitments other than the previously agreed study of Omidria for use in pediatric patients, which, if successfully completed, makes the drug eligible for an additional six months of marketing exclusivity in the US.

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. Ocular 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.