Fluocinolone acetonide micro-insert intravitreous implant - Alimera/pSivida

Drug Profile

Fluocinolone acetonide micro-insert intravitreous implant - Alimera/pSivida

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

Latest Information Update: 01 Aug 2018

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At a glance

  • Originator pSivida Inc
  • Developer Alimera Sciences; Hospital for Special Surgery; Johns Hopkins University; pSivida Inc
  • Class Anti-inflammatories; Antipruritics; Eye disorder therapies; Fluorinated steroids; Pregnadienes; Small molecules; Vasoconstrictors
  • Mechanism of Action 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
  • New Molecular Entity No
  • Available For Licensing Yes - Uveitis

Highest Development Phases

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

Most Recent Events

  • 01 Aug 2018 Updated efficacy and/or adverse events data from two phase III trials in Uveitis released by EyePoint Pharmaceuticals
  • 11 Jun 2018 Alimera Sciences expects the Technology Assessment 301 part-appraisal for Fluocinolone acetonide micro-insert intravitreous implant in Diabetic macular oedema (in patients with a natural lens) to be completed in 2019
  • 19 Mar 2018 FDA assigns PDUFA action date of 05/11/2018 for fluocinolone acetonide micro-insert intravitreous implant for posterior segment Uveitis
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