Retina Specialists Discuss RETISERT® and the MUST trial findings

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Limitations of the MUST study design and its implementation

Channels: Retina

Thomas Albini, MD, identifies the limitations of the MUST trial study design and its implementation, and how these limitations affect study results and interpretation.

Please see Indication and Important Safety Information below

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%).

Click here for full prescribing information on RETISERT®

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