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 dehiscence.
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 intraocular pressure.
Within an average post-implantation period of approximately 2 years, nearly all phakic eyes are expected to develop cataracts and require cataract surgery.
No information provided.
RETISERT is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infections of the eye and fungal diseases of ocular structures. RETISERT is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.