DEC 12, 2017
Cataract/Anterior Segment, Pediatric Ophth/Strabismus
The FDA has expanded the indication for Omidria, a mydriatic and pain-relief combination agent, to include use in pediatric patients from birth through 17 years.
The preservative-free drug (phenylephrine 1.0%, ketorolac 0.3%) is used to maintain adequate pupil diameter and reduce postoperative pain during cataract surgery and IOL replacement, where it is administered continuously through the irrigation fluid. The approval follows a successful clinical trial that enrolled over 70 children.
Omidria was approved for use in adults in 2014. The manufacturer, Omeros, was also granted an additional 6 months of U.S. market exclusivity.