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

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

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

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.

How to order RETISERT^® for your patients

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%).

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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

LONG-TERM CONTROL IS POSSIBLE WITH RETISERT®

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

RETISERT® safety profile