A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification.

Trial Profile

A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2015

At a glance

  • Drugs Ketorolac/phenylephrine (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Omeros Corporation
  • Most Recent Events

    • 03 Aug 2015 According to Omeros Corporation media release, the EC has approved Omidria in the EU for use in cataract surgery and lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative pain. The approval was based on data from this another phase III trial.
    • 22 May 2015 According to a media release from the European Medicines Agency, Omidria [ketorolac/phenylephrine] has received a positive opinion for from the Committee for Medicinal Products for Human Use (CHMP) for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.
    • 08 Aug 2013 Omeros plans to submit a MAA to the EMA in the third quarter of 2013 based on data from this trial, according to a media release.
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