US FDA and EMA accept Omeros regulatory applications for eye drug for review

2nd October 2013 (Last Updated October 2nd, 2013 18:30)

Omeros Corporation (OMER) announced that its new drug application (NDA) for OMS302, an ophthalmology product, has been accepted for filing by the FDA and its marketing authorisation application (MAA) for the same has been validated by the European Medicines Agency (EMA).

Intraocular-lens

Omeros Corporation (OMER) announced that its new drug application (NDA) for OMS302, an ophthalmology product, has been accepted for filing by the FDA and its marketing authorisation application (MAA) for the same has been validated by the European Medicines Agency (EMA).

According to the company, the NDA application submitted in July is complete to permit a substantive review.

In addition, the EMA validation of the MAA for OMS302 confirms that the submission package is complete and is ready for formal review by Europe's Committee for Medicinal Products for Human Use (CHMP).

The company is now looking for approval of OMS302 for use during intraocular lens replacement (ILR) surgery for the maintenance of intraoperative mydriasis, prevention of intraoperative miosis, and reduction of postoperative ocular pain.

The NDA would undergo FDA's standard review, while the MAA has been selected for EMA's centralised procedure in which a recommendation for approval by CHMP would cover approval for marketing of OMS302 across all EU member states and other countries in the European economic area.

"The acceptance for filing of our NDA by the FDA and validation of our MAA by the EMA mark important milestones on the path toward the commercial launch of OMS302 expected in 2014."

Omeros chairman and chief executive officer Gregory Demopulos said: "The acceptance for filing of our NDA by the FDA and validation of our MAA by the EMA mark important milestones on the path toward the commercial launch of OMS302 expected in 2014."

OMS302 combines the anti-inflammatory agent ketorolac and phenylephrine, a mydriatic (pupil dilating) agent; it is being developed for use during ILR surgery, cataract surgery and refractive lens exchange.

The ophthalmology product is added to standard irrigation solution used in ILR surgery and delivered intracamerally to maintain intraoperative mydriasis to prevent surgically induced miosis and to reduce postoperative pain and irritation.

Omeros intends to launch OMS302 commercially in 2014, pending regulatory approvals.


Image: OMS302 will be used during intraocular lens replacement (ILR) surgery, cataract surgery and refractive lens exchange. Photo: courtesy of Philos2000.