SEATTLE–(BUSINESS WIRE)–Dec. 12, 2017– Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system, today announced that the U.S. Food and Drug Administration (FDA) approved Omeros’ supplemental new drug application (sNDA) following review of efficacy and safety data from a pediatric clinical trial, expanding the indication for Omidria (phenylephrine and ketorolac intraocular solution) 1% / 0.3% to include use in pediatric patients (ages birth through 17 years old). Omidria, used during cataract surgery or intraocular lens (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 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.
“We are pleased that FDA has approved the use of Omidria in pediatric patients and granted additional market exclusivity,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “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.”
Omeros previously announced a favorable settlement of its patent infringement lawsuit against Par Pharmaceutical, Inc. and its subsidiary Par Sterile Products, LLC (Par) 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 similarly 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, the same court that 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, will 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 reduce 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, Omidria has been shown (1) to be effective in patients with intraoperative floppy iris syndrome (IFIS), pseudoexfoliation and other ophthalmic conditions, (2) to significantly reduce complication rates, use of pupil-expanding devices, and surgical times, and (3) to significantly improve uncorrected visual acuity on the first day following cataract surgery. While Omidria is broadly indicated for use in cataract surgery, the above outcomes are not in its currently approved labeling. Surgical time was not an endpoint in the Omidria Phase 3 clinical trials and did not reach statistical significance in post hoc analysis of the Phase 3 data.
Important Safety Information for Omidria
Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two percent or greater are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and Omidria-treated patients. Omidria must be added to irrigation solution prior to intraocular use.
About Omeros Corporation
In addition to Omeros’ commercial drug Omidria, Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with product commercialization and commercial operations, unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2017. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Source: Omeros Corporation
Posted: December 2017
Omidria (ketorolac and phenylephrine) FDA Approval History