Omidria Approved for Use in Pediatric Patients

The FDA approved the sNDA for Omidria under priority review
The FDA approved the sNDA for Omidria under priority review

The Food and Drug Administration (FDA) has approved an expanded indication for Omidria (phenylephrine and ketorolac intraocular solution 1%/0.3%; Omeros) to include use in pediatric patients (ages birth through 17 years old). 

Omidria is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement. It is indicated for maintaining pupil size by preventing intraoperative miosis and for reducing postoperative ocular pain. 

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The expanded approval was supported by evidence from well-controlled studies of adults with additional data from a single active-controlled safety study in pediatric patients up to 3 years old. In this study, patients (n=72) were randomized to either Omidria or phenylephrine. Mydriasis was maintained in the Omidria-treated group with no overall differences in safety observed between the pediatric and adult patients.

Omidria combines phenylephrine, an α1-adrenergic receptor agonist, with ketorolac, a nonsteroidal anti-inflammatory drug. Phenylephrine acts as a mydriatic agent by contracting the radial muscle of the iris. Ketorolac inhibits both cyclooxygenase enzymes (COX-1 and COX-2) resulting in a decrease in tissue concentrations of prostaglandins to reduce pain due to surgical trauma.

Omidria is supplied in single-patient-use vials containing 4mL of sterile solution, for addition to ocular irrigating solution. 

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