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 33% of patients.
You are encouraged to report side effects to the FDA. To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1‑800‑321‑4576 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information for RETISERT®.