Retisert



LONG-TERM CONTROL IS POSSIBLE WITH RETISERT®

RETISERT® effectively reduced uveitis recurrence rates¹

Uveitis recurrence rates decreased by more than 50% with RETISERT®¹

Uveitis recurrence rates dropped from 53.7% to 1.8% (Trial 1) and from 39.7% to 12.9% (Trial 2) 34 weeks post implantation, and control was maintained through 3 years of treatment with RETISERT®¹

Rate of disease recurrence in RETISERT®-implanted eyes¹

Study Design: Patients with chronic (>/= year history) noninfectious uveitis affecting the posterior segment of one or both eyes were randomized to receive a 0.59 mg RETISERT® implant in 2 independent, randomized, double-masked, multicentered, controlled clinical trials. In both trials, recurrence of uveitis for all post implantation time points was compared to the 34-week pre implantation time point.¹

Study Design: Patients with chronic (>/= year history) noninfectious uveitis affecting the posterior segment of one or both eyes were randomized to receive a 0.59 mg RETISERT® implant in 2 independent, randomized, double-masked, multicentered, controlled clinical trials. In both trials, recurrence of uveitis for all post implantation time points was compared to the 34-week pre implantation time point.¹

Recurrence was defined as any one of the following: 1) increase in the number of cells in the anterior chamber of ≥2 steps compared to baseline; 2) increase in vitreous haze of ≥2 steps compared with baseline; or 3) deterioration of vision of at least +0.30 logMAR from baseline, not attributable to conditions other than non-infectious posterior uveitis²

RETISERT® stabilized vision and reduced the need for adjunctive therapy²

experienced stabilized or improved visual acuity²

Visual acuity improved by 3 lines in 20% to 30% of RETISERT®-implanted eyes between baseline and 3 years post implantation²

 

Significant reduction of periocular injections and systemic medication to control uveitis²

P<0.01 compared to preimplant rate at all time points

RETISERT® safety profile

Ocular adverse events

  • The most frequently reported ocular adverse events in clinical trials with RETISERT® occurring in 50%-90% of patients included: cataract, increased IOP, procedural complications, and eye pain. 10-40% of patients reported ocular/conjunctival hyperemia, reduced visual acuity, and conjunctival hemorrhage. The most common nonocular event reported was headache (33%)¹

During the 3-year post implantation period, 37% of RETISERT®-implanted eyes required surgical intervention to manage elevated IOP across 3 trials¹

  • Topical IOP-lowering medications were administered to approximately 77% of RETISERT®-implanted eyes over 3 years¹

Nearly all phakic RETISERT®-implanted eyes are expected to develop cataracts and require surgery¹*

*Study design: Combined data from RETISERT® clinical trials. A total of 517 subjects (Trial 1, n=278; Trial 2, n=239) were randomized in these 3-year, double-masked, multicenter, controlled phase 2b/3 safety and efficacy clinical trials. Primary efficacy endpoint: Uveitis recurrence rate.

Please see Important Safety Information below.

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. Callanan DG, Jaffe GJ, Martin DF, Pearson PA, Comstock TL. Treatment of posterior uveitis with a fluocinolone acetonide implant: three-year clinical trial results. Arch Ophthalmol. 2008;126(9):1191-201. 3. Sangwan VS, Pearson PA, Paul H, Comstock TL. Use of the fluocinolone acetonide intravitreal implant for the treatment of noninfectious posterior uveitis: 3-year results of a randomized clinical trial in a predominantly Asian population. Ophthalmol Ther. 2015;4(1):1-19.

Indication and Important Safety Information

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.

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