FOR PATIENTS WITH CHRONIC NONINFECTIOUS POSTERIOR UVEITIS

DELIVER LONG-TERM CONTROL OF INFLAMMATION WITH RETISERT®¹

RETISERT® offers

  • OVER 12 YEARS of surgical implantation experience²
  • LASTING INFLAMMATION REDUCTION Corticosteroid therapy for up to approximately 2.5 years where it's needed¹

Indication

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 for RETISERT®.

References: 1. RETISERT [Package Insert]. Rochester, NY: Bausch & Lomb Incorporated.; May 2019. 2. U.S. Food & Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021737s000TOC.cfm Accessed October 4, 2017.

 

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