Why RETISERT® May Be Right For You

RETISERT® is a corticosteroid implant that delivers medication to the back of the eye for continuous inflammation control

RETISERT® is

An implant that can deliver up to 2 ½ years of continuous treatment for chronic noninfectious uveitis

Very small, about the size of a grain of rice, and is surgically placed into the eye so it can deliver medicine directly into the back of the eye–exactly where it is needed

Surgically implanted in a hospital outpatient setting. The procedure takes about 1 hour and after a short recovery period, you can usually go home the same day

What are some possible side effects to be aware of?

  • RETISERT® can cause side effects such as cataract formation or high eye pressure
  • 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. Individual results may vary
  • Please see Important Safety Information below

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 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®.

Indication and Important Safety Information