Retisert (fluocinolone acetonide intravitreal implant) 0.59 mg

In patients with chronic non-infectious posterior uveitis RETISERT is designed to deliver corticosteroid therapy for approximately 2.5 years precisely where it’s needed.

RETISERT (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3 to 0.4 μg/day over approximately 30 months.

How Supplied: The implant consists of a tablet encased in a silicone elastomer cup containing a release orifice and a polyvinyl alcohol membrane positioned between the tablet and the orifice. The silicone elastomer cup assembly is attached to a silicone elastomer suture tab with silicone adhesive.

Inactive ingredients: Microcrystalline cellulose, polyvinyl alcohol, and magnesium stearate.

Please click here to view the RETISERT full Prescribing Information.



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Indication and Usage

RETISERT (fluocinolone acetonide intravitreal implant) 0.59 mg is a corticosteroid indicated for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.

Important Safety Information

  • Surgical placement of RETISERT (fluocinolone acetonide intravitreal implant) 0.59 mg is contraindicated in active viral, bacterial, mycobacterial or fungal infections of the eye.
  • Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery.
  • As with any surgical procedure, there is risk involved. Potential complications accompanying intraocular surgery to place RETISERT into the vitreous cavity may include, but are not limited to, the following: cataract formation, choroidal detachment, endophthalmitis, hypotony, increased intraocular pressure, exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, and wound dehiscence.
  • Following implantation of RETISERT, nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately one to four weeks post-operatively.
  • Use of corticosteroids may result in elevated IOP and/or glaucoma.Based on clinical trials with RETISERT, within 3 years post-implantation, approximately 77% of patients will require IOP lowering medications to control intraocular pressure and 37% of patients will require filtering procedures to control intraocular pressure.
  • Patients should be advised to have ophthalmologic follow-up examinations of both eyes at appropriate intervals following implantation of RETISERT. Physicians should periodically monitor the integrity of the implant by visual inspection.
  • Ocular administration of corticosteroids has been associated with delayed wound healing and perforation of the globe where there is thinning of the sclera.
  • The most frequently reported ocular adverse events in clinical trials with RETISERT occurring in 50-90% of patients included: cataract, increased intraocular pressure, procedural complications and eye pain. The most common non-ocular event reported was headache (>33%).

RETISERT (fluocinolone acetonide intravitreal implant) 0.59 mg : Additional information

US/RET/15/0015

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