Fluocinolone acetonide micro-insert intravitreous implant - pSivida

Drug Profile

Fluocinolone acetonide micro-insert intravitreous implant - pSivida

Alternative Names: DF-277; Durasert™ three-year uveitis insert; FAI insert; Fluocinolone; Fluocinolone acetonide intravitreal insert; Iluvien; Injectable micro-insert - pSivida; Medidur; Medidur-FA; NSC-92339; Ophthalmic implant - Alimera Sciences/pSivida

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator pSivida Inc
  • Developer Alimera Sciences; Johns Hopkins University; pSivida Inc
  • Class Anti-inflammatories; Eye disorder therapies; Fluorinated steroids; Pregnadienes; Small molecules
  • Mechanism of Action Arachidonic acid inhibitors; Glucocorticoid receptor agonists; Phospholipase A2 inhibitors
  • Orphan Drug Status

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

    No
  • 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Diabetic macular oedema
  • Phase III Uveitis
  • No development reported Dry age-related macular degeneration; Retinal vascular occlusion; Wet age-related macular degeneration

Most Recent Events

  • 02 Nov 2016 MEAgate initiates Named Patient Access Programme for Fluocinolone acetonide micro-insert intravitreous implant in Saudi Arabia, Egypt, United Arab Emirates, Lebanon and other middle eastern countries before November 2016
  • 04 Oct 2016 pSivida announces intention to submit MAA to the European Medicines Agency in the first quarter of 2017 for Uveitis
  • 04 Oct 2016 pSivida announces intention to submit NDA to the US FDA for the treatment of Uveitis in the second half of 2017
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