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Sirolimus ophthalmic - Santen Pharmaceutical

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Drug Profile

Sirolimus ophthalmic - Santen Pharmaceutical

Alternative Names: DE-109; MS-R001; Opsiria; Perceiva; STN-10109; STN-1010900; STN-1010905

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator MacuSight
  • Developer MacuSight; Midwest Eye Institute; Santen Pharmaceutical
  • Class Anti-infectives; Anti-inflammatories; Antiepileptic drugs; Antifungals; Antineoplastics; Cardiovascular therapies; Eye disorder therapies; Lactones; Macrolides; Nootropics; Polyenes; Pyridines; Skin disorder therapies
  • Mechanism of Action Immunosuppressants; Methylmalonyl CoA mutase stimulants; MTOR protein inhibitors; T lymphocyte 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 II Meibomian gland dysfunction
  • Discontinued Diabetic macular oedema; Dry eyes; Wet age-related macular degeneration

Most Recent Events

  • 24 Oct 2023 Santen in collaboration with Stanford University withdraws a phase II SAVE-2 trial in Uveitis in USA (Intravitreous), prior to enrolment due to sponsor decision (NCT01280669)
  • 18 Nov 2022 Santen terminates phase-III LUMINA trial in Uveitis in USA, Argentina, India and Italy due to business decision (NCT03711929; 010906IN) (EudraCT2019-003638-18).
  • 31 Aug 2022 Santen Pharmaceutical completes a phase-II clinical trials in Meibomian gland dysfunction in Japan in August 2022 (Ophthalmic) (jRCT2031210371)

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