Sirolimus ophthalmic - Santen Pharmaceutical

Drug Profile

Sirolimus ophthalmic - Santen Pharmaceutical

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

Latest Information Update: 27 Dec 2016

Price : $50

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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Diabetic macular oedema
  • 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

  • 01 Dec 2016 Santen completes the global phase III SAKURA trial for Uveitis (NCT01358266)
  • 28 Nov 2016 Santen Pharmaceutical announces intention to submit NDA to US FDA in in early 2017
  • 04 Jul 2016 The Central Drugs Standard Control Organization (CDSCO) of India issues a positive recommendation for the import and marketing of Sirolimus 22 mg/mL intravitreal solution
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