12 December 2017 - FDA also grants additional market exclusivity.

Omeros Corporation today announced that the U.S. FDA approved Omeros’ supplemental new drug application following review of efficacy and safety data from a paediatric clinical trial, expanding the indication for Omidria (phenylephrine and ketorolac intraocular solution) 1% / 0.3% to include use in paediatric patients (ages birth through 17 years old). Omidria, used during cataract surgery or intra-ocular lens replacement, prevents intra-operative miosis (pupil constriction) and reduces postoperative pain. FDA approved the sNDA for Omidria under priority review.

The successful clinical trial was conducted in 78 paediatric patients randomised to either Omidria or phenylephrine administered intra-operatively. Together with the label expansion now including both paediatric 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.

Read Omeros Corporation press release