RETISERT is designed to locally treat inflammation in the eye, but it is not known to treat the underlying
disease. Medication to treat the underlying disease may be prescribed concurrently as deemed appropriate by a
physician. Patients should be advised to have ophthalmologic follow-up examinations of both eyes at appropriate
intervals following implantation of RETISERT.
As with any surgical procedure, there is risk involved. Potential complications accompanying intraocular surgery
to place RETISERT into the vitreous cavity may include, but are not limited to, the following: cataract formation,
choroidal detachment, temporary decreased visual acuity, endophthalmitis, hypotony, increased intraocular pressure,
exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, and wound
Following implantation of RETISERT, nearly all patients will experience an immediate and temporary decrease in
visual acuity in the implanted eye which lasts for approximately one to four weeks postoperatively. This decrease in
visual acuity is likely a result of the surgical implant procedure.
Based on clinical trials with RETISERT, within 34 weeks post-implantation, approximately 60% of patients will
require IOP lowering medications to control intraocular pressure. Within an average post-implantation period of
approximately 2 years, approximately 32% of patients are expected to require filtering procedures to control
Within an average post-implantation period of approximately 2 years, nearly all phakic eyes are expected to
develop cataracts and require cataract surgery.