Key Points for Patient Education

Before initiating treatment with Retisert^® (fluocinolone acetonide intravitreal implant 0.59 mg, Bausch + Lomb), the physician must ensure patients have a solid understanding of its risks and benefits. It is helpful if they first understand that chronic uveitis may require treatment for a long time, sometimes years.

Likening the condition to arthritis helps some patients better understand their situation. For example, our practice website provides this explanation: “Arthritis is inflammation of the joints of the body. The body's immune system becomes confused and starts to attack or reject the cartilage in the joints of the body, leading to joint damage and loss of function. The only way to prevent this damage is to suppress the immune system with corticosteroids or immunosuppressive drugs. Similarly, in uveitis, the body's immune system attacks the eye. Unless the immune system is kept in check by the use of either steroids or other immunosuppressive drugs, loss of vision, retinal damage, cataracts, and glaucoma can occur.”

The following key points should be conveyed to patients in formal informed consent materials for the Retisert procedure and doctor-patient conversations.

■ Keeping scheduled follow-up visits is necessary to monitor the eye for side effects and safeguard vision. I see patients 1 day, 1 week and 1 month after Retisert implantation. In general, unless problems arise, I see them again at 3- to 6-month intervals.
■ Procedural complications that can be associated with Retisert include endophthalmitis, cataract formation, choroidal detachment, hypotony, increased intraocular pressure (IOP), exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, postoperative wound site erythema and wound dehiscence. Late onset endophthalmitis has been observed, often related to the integrity of the surgical wound site.
■ Following Retisert implantation, patients may experience a decrease in visual acuity. In my experience, this typically lasts for 1-4 weeks after surgery. Patients may experience headache and eye pain as well.
■ Side effects likely to occur with long-term ocular exposure to corticosteroids also include elevated IOP and/or glaucoma, with damage to the optic nerve and defects in visual acuity and fields of vision. Topical medication to control IOP and/or IOP-lowering surgery may be required. 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.
■ Side effects likely to occur with long-term ocular exposure to corticosteroids include cataract formation. Cataract surgery may be required. Based on clinical trials of Retisert, during the 3-year post-implantation period nearly all phakic eyes are expected to develop cataracts and require cataract surgery.
■ The most frequently reported ocular adverse events in clinical trials with Retisert were eye pain, cataract, increased IOP and procedural complication. These events occurred in approximately 50%-90% of patients.
■ Side effects likely to occur with long-term ocular exposure to corticosteroids also include an increase in the hazard of secondary ocular infections (bacterial, fungal and viral).

As with all other treatments and procedures, it is recommended that Retisert patients receive not only formal informed consent materials but also a written explanation of risks and benefits in layman's terms, including instructions on how to contact your office if necessary.

For more information, read complete prescribing information at http://www.bausch.com/en_US/downloads/ecp/pharma/general/retisert_pkginsert.pdf.