Indication and Usage





RETISERT® (fluocinolone acetonide intravitreal implant) 0.59 mg is used to treat an inflammation in the back of the eye that is not caused by an infection, called chronic non-infectious uveitis.

What is chronic noninfectious uveitis?





If you have been diagnosed with chronic noninfectious uveitis affecting the back of your eye, here’s what that means:

  • Uveitis is inflammation inside the eye that affects the uvea (the middle layer of the eye).

  • It is noninfectious, which means it was not caused by a virus or bacteria, and the exact cause of the inflammation may be unknown.1

  • Uveitis is often a chronic disease, meaning that the symptoms you experience may be persistent, lasting for months or years. You might also have “flare-ups” of inflammation that can last for short or long periods.2

  • Uveitis in the back of the eye is a serious condition.2

  • Each time a flare-up of inflammation happens it can damage the tissue of the eye, and the damage can add up over time.2



How does treatment with RETISERT® (fluocinolone acetonide intravitreal implant) 0.59 mg help?






  • RETISERT® delivers medication to reduce the inflammation at the back of the eye on a continuous basis.

  • RETISERT® is the only drug implant approved by the US Food and Drug Administration (FDA) that can deliver up to 30 months of continuous treatment for chronic noninfectious uveitis affecting the back of the eye.

  • RETISERT® is very small, about the size of a grain of rice, and surgically placed in the eye so it can deliver medicine directly to the back of the eye.

  • RETISERT® is surgically implanted in the eye, in a hospital outpatient setting. In most cases, the procedure takes approximately 1 hour. After a short recovery period in the surgery center, you can usually go home the same day.



What are some of the possible side effects?






  • Corticosteroid treatments, such as implantation of the RETISERT® intravitreal implant, can cause side effects like cataract formation or high eye pressure.3

  • Nearly all patients who have not already had cataracts will develop them and require surgery within 2 to 3 years after implantation of the RETISERT® intravitreal implant.3



Please see additional important Safety Information below.



How effective is RETISERT®?




50% reduction

In 2 clinical studies, repeated flareups of inflammation were reduced by more than 50% during the 3 years following treatment with RETISERT®.3






8/10 patients

Although individual results may vary, in clinical trials of 224 patients who were treated with RETISERT® 8 out of 10 patients had improved or stabilized vision.3





The RETISERT® Procedure






Surgery

The procedure used to implant RETISERT® is performed in an outpatient setting. This means that you will usually be able to go home the same day and you will not have to be hospitalized. Only local anesthesia may be used to numb your eye, sparing you the risks associated with general anesthesia.

After
Surgery

A decrease in vision should be expected for approximately 1 to 4 weeks after surgery before there is improvement. Your doctor will want to monitor your progress, examine your eyes, and look for improvements or any changes in the condition of the implanted eye.3






Follow up After Surgery





 Follow-up visits: Year 1

 Every 2 to 3 months

 Follow-up visits Year 1-2

 Every 2 to 4 months

 Your doctor will check for:

 Inflammation
 Cataract formation
 High eye pressure (IOP)
 Gains or losses in vision
 These follow-up visits are very important. Your doctor needs to check for any changes in the condition of the  implanted eye. Even if you are feeling fine or your vision has improved a lot, you still need to see your doctor for  follow-up care.

 In addition to having your vision checked, it is very important that you be monitored for increases in eye  pressure.  If your eye pressure is high, your doctor can prescribe eye drops to bring the pressure down. Some  people may  require a surgical procedure to relieve the pressure in the eye.3



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Important Safety Information





  • Retisert® (fluocinolone acetonide intravitreal implant) 0.59 mg should not be used if you have an infection of the eye from viruses, bacteria, fungi or fungal diseases.

  • After receiving the Retisert® implant, you should periodically see an eye doctor for follow-up examinations of both eyes.

  • As with any surgical procedure, there is risk involved. Complications can include injury to the eye; infection; mechanical complication, movement or ejection of the implant; and wound complications following the surgery.

  • After receiving the Retisert® implant, nearly all patients will experience an immediate and temporary decrease in vision in the implanted eye that lasts for approximately 1 to 4 weeks following the surgery.

  • Based on clinical studies, within 3 years after receiving the Retisert® implant, approximately 77% of patients require medications to lower pressure in the eye, and approximately 37% of patients will require a surgical procedure to control pressure in the eye.

  • Long-term use of corticosteroids may result in an increased risk of glaucoma (high pressure in the eye).

  • Based on clinical studies, within 3 years after receiving the Retisert® implant, nearly all patients who have not already had cataracts will develop them and require surgery.

  • The most common side effects, occurring in 50-90% of patients, were cataract, increased pressure in the eye, surgery complications and eye pain. Headache was also reported in greater than 33% of patients



Please see full Prescribing Information for Retisert®

You are encouraged to report negative side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.