Omeros Corporation has received FDA approval to expand the indication for Omidria (phenylephrine and ketorolac intraocular solution) 1%/0.3% to include use in pediatric patients (from birth through 17 years). Omidria is used during cataract surgery or intraocular lens replacement to prevent intraoperative miosis (pupil constriction) and to reduce postoperative pain. It is the only nonsteroidal anti-inflammatory drug-containing product that is FDA-approved for intraocular use.
The supplemental new drug application (sNDA) was granted priority review and was approved following review of efficacy and safety data from a pediatric clinical trial. The trial was conducted in 78 pediatric patients randomized to either Omidria or phenylephrine administered intraoperatively. Together with the label expansion, the 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 the FDA’s Orange Book.
Omeros previously announced a favorable settlement of its patent infringement lawsuit against Par Pharmaceutical, Inc., and its subsidiary Par Sterile Products, LLC, in which Par acknowledged and confirmed the validity of the Orange Book-listed patents for Omidria. Unless subsequently authorized pursuant to terms in the settlement agreement, Par is prohibited from launching a generic version of Omidria until April 1, 2032. These same patents are being asserted against Sandoz, Inc., and Lupin Ltd. in Hatch-Waxman litigation planned for trial in mid-2019 in the U.S. District Court for the District of Delaware, which presided over the Par case. If that court upholds and finds infringement of any claim in the Orange Book-listed patents for Omidria that expire in October 2033, Sandoz and Lupin, as a result of the newly granted market exclusivity, would be precluded from launching a generic version of Omidria until April 2034.
Source: Omeros; December 12, 2017.