Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

Trial Profile

Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

Completed
Phase of Trial: Phase II

Latest Information Update: 22 May 2015

At a glance

  • Drugs Ketorolac/phenylephrine (Primary) ; Anti-inflammatories; Mydriatics
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 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.
    • 19 Apr 2013 The phase II and III data analyses will be included in both the US and European marketing applications for OMS 302, according to an Omeros media release.
    • 19 Apr 2013 Additional data from analyses of phase II and III trials will be presented at the Annual American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Symposium and Congress, according to an Omeros media release.
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