The FDA has approved Omeros’ supplemental new drug application that expands the indication of Omidria (phenylephrine and ketorolac intraocular solution) 1%/0.3% to include use in pediatric patients (ages birth through 17 years old). The approval followed a review of efficacy and safety data from a pediatric clinical trial. Omidria, used during cataract surgery or IOL replacement, prevents intraoperative miosis (pupil constriction) and reduces postoperative pain. FDA approved the sNDA for Omidria under priority review.
The successful clinical trial was conducted in 78 pediatric patients randomized to either Omidria or phenylephrine administered intraoperatively. Together with the label expansion now including both pediatric and adult patients, FDA also granted Omidria an additional 6 months of U.S. market exclusivity. Under section 505A of the Federal Food, Drug, and Cosmetic Act, this 6-month extension of market exclusivity is attached to the term of the drug’s patents listed in FDA’s Orange Book.
“We are pleased that FDA has approved the use of Omidria in pediatric patients and granted additional market exclusivity,” Gregory A. Demopulos, MD, chairman and chief executive officer of Omeros, said in a company news release. “Now all patients undergoing cataract or other lens replacement surgery can receive the benefits of Omidria. These procedures are more complex in pediatric patients than in adults, and it’s gratifying to know that our drug will be helping children.”