Omidria Gets FDA Approval

Omeros announced that the FDA has approved Omidria (phenylephrine and ketorolac) injection for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis and to reduce postoperative pain.

Omidria contains phenylephrine, a mydriatic agent, and ketorolac, an anti-inflammatory agent. This combination is added to an irrigation solution used as a standard in cataract surgery and other ILR procedures.

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Omidria was evaluated in trials in which all patients received standard pupil-dilating and anesthetic agents prior to surgery. Omidria showed statistically significant and clinically meaningful improvement in the prevention of miosis and reduction of postoperative pain vs. placebo.

Omidria will be available in a 1%/0.3% strength in 4- and 10- single-use 5mL vials. The product is anticipated to launch in the late summer/early fall of 2014.

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