Omeros Announces U.S. Commercial Launch Of Omidria

(RTTNews) - Omeros Corp. (OMER) announced the nationwide commercial availability of Omidria (phenylephrine and ketorolac injection) 1%/0.3%.

Omidria is the first and only product approved by the U.S. Food and Drug Administration or FDA for intraocular administration during cataract surgery and other intraocular lens or IOL replacement procedures to prevent intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain, providing consistent and predictable management of these problems for ophthalmic surgeons and their patients.

A large and growing market, cataract and other IOL replacement procedures are among the most common surgical procedures performed in the U.S. with approximately four million expected in 2015.

Omidria was granted transitional pass-through status effective January 1, 2015 from the Center for Medicare & Medicaid Services (CMS), the federal agency that administers the Medicare program. Pass-through status allows for separate payment for new drugs and other medical technologies that meet specific clinical-value and cost requirements. Pass-through status for Omidria is expected to remain in effect until December 31, 2017, near which time CMS will evaluate utilization of Omidria and will re-assess its reimbursement status.

CMS has set the reimbursement rate for Omidria under Medicare Part B at the product's wholesale acquisition cost (WAC) of $465 plus six percent per single-use vial for the second and third quarters of 2015 after which the rate will be based on average selling price (ASP) plus six percent.