Sirolimus ophthalmic - Santen Pharmaceutical

Drug Profile

Sirolimus ophthalmic - Santen Pharmaceutical

Alternative Names: DE-109; MS-R001; Opsiria; Perceiva

Latest Information Update: 22 May 2017

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At a glance

  • Originator MacuSight
  • Developer Johns Hopkins University; MacuSight; Midwest Eye Institute; Santen Pharmaceutical
  • Class Anti-infectives; Antifungals; Antineoplastics; Lactones; Macrolides; Polyenes; Pyridines
  • Mechanism of Action MTOR protein inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Uveitis
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Uveitis
  • Phase III Wet age-related macular degeneration
  • Discontinued Diabetic macular oedema; Dry eyes

Most Recent Events

  • 26 Apr 2017 Preregistration for Uveitis in USA (Intravitreous)
  • 26 Apr 2017 US FDA accepts NDA for sirolimus intravitreal injection for Uveitis for review
  • 25 Apr 2017 The US FDA sets PDUFA date of December 24, 2017 for NDA review for Uveitis
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