Oct. 15, 2013
/PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) confirmed its agreement with the Pediatric Study Plan (PSP) proposed by Omeros to study the use of OMS302 in pediatric patients undergoing primary cataract extraction. The FDA also issued a Written Request consistent with the PSP, which means that successful completion of the PSP would make OMS302 eligible for an additional six months of marketing exclusivity in the U.S. Added to standard irrigation solution used during ophthalmological procedures, OMS302 is Omeros' proprietary PharmacoSurgery
product designed to maintain intraoperative mydriasis (pupil dilation), prevent surgically induced miosis (pupil constriction), and reduce postoperative pain resulting from cataract and other lens replacement surgery.
As announced in July, the European Medicines Agency approved Omeros' Pediatric Investigation Plan to study the use of OMS302 in pediatric patients, which is expected to lead to additional marketing exclusivity in
. Omeros has OMS302 marketing applications under review in the U.S. and
with anticipated market launch in 2014. Results of the pediatric studies are expected to be available during the post marketing period.
"The OMS302 studies in pediatric populations that have now been approved in both the U.S. and
are planned to begin in 2014 and, given the strength of our data in the adult population, we expect that OMS302 will show similar benefits in pediatric patients," stated
Gregory A. Demopulos
, M.D., chairman and chief executive officer of Omeros. "With FDA's Written Request and agreement on our Pediatric Study Plan, we now have clear paths forward to obtain additional marketing exclusivity for our drug in both the U.S. and
. We look forward to making OMS302 available to ophthalmic surgeons and their patients in these major markets next year."
About Omeros' OMS302 Program
OMS302 is Omeros' product being developed for use during intraocular lens replacement (ILR), including cataract surgery and refractive lens exchange. OMS302 is a proprietary combination of the mydriatic (pupil dilating) agent phenylephrine and the anti-inflammatory agent ketorolac. Omeros' NDA for OMS302 has been accepted for filing by the FDA and its MAA for OMS302 has been validated by the EMA.
ILR involves replacement of the original lens of the eye with an artificial intraocular lens. These procedures are typically performed to replace a lens opacified by a cataract or to correct a refractive error of the lens (i.e., refractive lens exchange). OMS302 is added to standard irrigation solution used in ILR and delivered within the eye to maintain intraoperative mydriasis (pupil dilation), to reduce surgically induced miosis (pupil constriction), and to reduce postoperative pain and irritation. Maintenance of mydriasis is critical to the safety and surgical ease of the procedure. Intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time.