FDA approves OMIDRIA for use in pediatric patients
Omeros secures FDA approval of OMIDRIA for use in pediatric patients
Omeros Corporation (OMER) announced that the U.S. Food and Drug Administration approved Omeros’ supplemental new drug application following review of efficacy and safety data from a pediatric clinical trial, expanding the indication for OMIDRIA 1% / 0.3% to include use in pediatric patients.
OMIDRIA, used during cataract surgery or intraocular lens replacement, prevents intraoperative miosis 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 six months of U.S. market exclusivity.
Under section 505A of the Federal Food, Drug, and Cosmetic Act, this six-month extension of market exclusivity is attached to the term of the drug’s patents listed in FDA’s Orange Book.
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