Important Risk Information for Retisert^®

Surgical placement of RETISERT^® (fluocinolone acetonide intravitreal implant 0.59 mg, Bausch + Lomb) is contraindicated in active viral, bacterial, mycobacterial or fungal infections of the eye.

Based on clinical trials with RETISERT^®, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery.

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, wound complication, wound site erythema 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 post-operatively.

Use of corticosteroids may result in elevated IOP and/or glaucoma. Based on clinical trials with RETISERT^®, within 3 years post-implantation, approximately 77% of patients will require IOP lowering medications to control intraocular pressure and 37% of patients will require filtering procedures to control intraocular pressure.

Patients should be advised to have ophthalmologic follow-up examinations of both eyes at appropriate intervals following implantation of RETISERT^®. Physicians should periodically monitor the integrity of the implant by visual inspection.

The most frequently reported ocular adverse events in clinical trials with RETISERT^® occurring in 50-90% of patients included: cataract, increased intraocular pressure, procedural complications and eye pain. Thirty five to forty percent (35-40%) of patients reported ocular/conjunctival hyperemia, reduced visual acuity and conjunctival hemorrhage. The most common non-ocular event reported was headache (>33%).

For more information, read complete prescribing information at http://www.bausch.com/en_US/downloads/ecp/pharma/general/retisert_pkginsert.pdf.