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.

.

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.