FDA Approves Omeros' Omidria For Use In Cataract And ILR Procedures

(RTTNews) - The U.S.Food and Drug Administration or FDA granted approval for Omeros Corp.'s (OMER) product Omidria 1%/0.3%, for its use during cataract surgery and intraocular lens replacement or ILR procedures.

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 U.S.

Omeros' PharmacoSurgery product Omidria is a proprietary combination of the pupil-dilating agent phenylephrine and the anti-inflammatory agent ketorolac, which was developed for use during cataract or other intraocular lens replacement surgery.

In pivotal trials, where all patients received standard pupil-dilating and anesthetic agents before surgery, Omidria showed statistically significant and clinically meaningful improvement in the prevention of miosis and reduction of postoperative pain compared with placebo.

With the FDA approval of Omidria, the company is preparing for the product launch in U.S for late summer or early fall in 2014.