Rx Pharmaceuticals
Retisert® (fluocinolone acetonide intravitreal implant) 0.59 mg
Key Features & Benefits
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Provides fluocinolone acetonide precisely where it’s needed.
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Offers long-term control of inflammation.
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Manageable side-effect profile.
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Dramatically reduces recurrence rates.
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At 34 weeks, approximately 80% of patients demonstrated stabilization or improvement in visual acuity, while 20% experienced a decrease.
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A straightforward surgical procedure that can be performed in an outpatient hospital setting.
Product Detail Information
Bausch & Lomb Retisert® (fluocinolone acetonide intravitreal implant) 0.59 mg is the world's first intravitreal drug implant for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Uveitis is one of the leading causes of blindness for middle-aged people in the Western world. It is estimated to cause 10% to 15% of all cases of total blindness in the United States.1
Retisert® represents a dramatic advance in the management of chronic noninfectious uveitis affecting the posterior segment of the eye. Now, for the first time, retina and uveitis specialists have the means to provide consistent long-term delivery of a corticosteroid agent, fluocinolone acetonide, precisely where it's needed.
Bausch & Lomb's patented drug-delivery microtechnology in Retisert consists of a tiny drug reservoir designed to deliver sustained levels of the well-known anti-inflammatory corticosteroid, fluocinolone acetonide, for approximately two-and-a-half years (30 months) directly to the back of the eye.
For more information about Retisert, please contact Customer Service at (800) 323-0000 or visit www.retisert.com.
Safety Information
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, temporary decreased visual acuity, endophthalmitis, hypotony, increased intraocular pressure, exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, and wound dehiscence.
Based on clinical trials with RETISERT®, within 34 weeks post implantation approximately 60% of patients will require IOP lowering medications to control intraocular pressure. Within an average post-implantation period of approximately 2 years, approximately 32% of patients are expected to require filtering procedures to control intraocular pressure, and nearly all phakic eyes are expected to develop cataracts and require cataract surgery.
The most frequently reported ocular adverse events in the overall study population were cataract, increased intraocular pressure, procedural complications, and eye pain. These events occurred in approximately 50% to 90% of patients. Procedural complication includes cataract fragments in the eye post-op, implant expulsion, injury, mechanical complication of implant, migration of implant, post-op complications, post-op wound complications, and wound dehiscence.
