Retisert (fluocinolone acetonide intravitreal implant)
0.59 mg




Please click to view the Retisert Prescribing Information.




Indication

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.

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