Omeros Corporation has received U.S. Food and Drug Administration (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 utilized during cataract surgery or intraocular lens replacement to prevent miosis (pupil constriction) and to decrease postoperative pain.
It is the main nonsteroidal anti-inflammatory drug-containing product that is FDA-approved for intraocular utilize. The supplemental new drug application (sNDA) was granted priority review and was approved following the review of safety and efficacy information from a pediatric clinical trial.
The trial was led in 78 pediatric patients randomized to either Omidria or phenylephrine regulated intraoperatively. Together with the label development, the FDA likewise granted Omidria an additional a half year of U.S. market exclusivity.
Under section 505A of the Federal Food, Drug, and Cosmetic Act, this half year extension of market exclusivity is connected to the term of the drug’s patents recorded in the FDA’s Orange Book. Omeros already declared a favorable settlement of its patent infringement lawsuit against Par Pharmaceutical, Inc., and its subsidiary Par Sterile Products, LLC, in which Par recognized and confirmed the validity of the Orange Book-listed patents for Omidria.
Unless in this manner approved as per terms in the settlement agreement, Par is denied 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 the Par case.
If that court upholds and discovers the infringement of any case in the Orange Book- listed patents for Omidria that expire in October 2033, Sandoz and Lupin, because of the recently granted market exclusivity, would be precluded from launching a generic version of Omidria until April 2034.
Omeros’ OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% is the only FDA- approved product for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to decrease postoperative ocular pain. OMIDRIA also is the only NSAID-containing product FDA- approved for intraocular use. In post- launch studies across conventional and femtosecond laser- assisted cataract surgery. To significantly reduce complication rates, use of pupil expanding devices, and surgical times, and to fundamentally enhance uncorrected visual acuity on the first day following cataract surgery, OMIDRIA has been appeared to be effective in patients with pseudoexfoliation, intraoperative floppy iris syndrome (IFIS) and other ophthalmic conditions. While OMIDRIA is comprehensively shown for use in cataract surgery, the above results are not in its right now approved labeling. In the OMIDRIA Phase 3 clinical trials, surgical time was not an endpoint and did not achieve statistical significance in post hoc analysis of the Phase 3 information.
Important Safety Information for OMIDRIA:
Phenylephrine may cause elevations in blood pressure. In clinical trials, the most widely reported ocular adverse reactions at two percent or more prominent are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was comparable between placebo treated and OMIDRIA-treated patients. OMIDRIA must be added to irrigation solution preceding intraocular use.