Rx Pharmaceuticals

Vitrasert® (ganciclovir intravitreal implant) 4.5 mg

Product Information

The Vitrasert® implant is a device that delivers ganciclovir intraocularly in patients with AIDS-related Cytomegalovirus (CMV) Retinitis. This approach can significantly delay progression of CMV when compared with conventional ganciclovir intravenous treatment. Data from the Bausch & Lomb Phase III trial of 188 AIDS patients with newly diagnosed CMV Retinitis demonstrated that time to disease progression was significantly delayed for patients who received the Vitrasert implant, compared with those on intravenous (I.V.) ganciclovir. The median time to progression was approximately 210 days for the Vitrasert implant treated group compared to approximately 129 days for the I.V. ganciclovir group.

The Vitrasert implant contains ganciclovir embedded in a polymer-based system that slowly releases the drug over a 5 to 8 month period of time. The implant, surgically placed in the posterior segment of the eye, allows diffusion of the drug locally to the site of infection.

Implantation typically takes less than one hour, requires only local anesthesia, and is conducted in an outpatient, day-surgery setting.

Immediately following insertion of the implant, nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye, likely a result of the surgical implant procedure, which lasts for approximately two to four weeks post-operatively. The implant can be removed when depleted of drugs, usually within five to eight months, and a new Vitrasert implant can be inserted.

Important Safety Information

The Vitrasert implant provides localized therapy limited to the implanted eye. It does not provide treatment for systematic CMV disease. Patients should be monitored for non-ocular CMV disease.

Implantation is generally performed as outpatient surgery. Potential complications are those commonly associated with intraocular surgery, including vitreous loss, vitreous hemorrhage, cataract formation, retinal detachment, uveitis, endophthalmitis, and temporary decrease in visual acuity. Some of these complications were seen in the clinical trials for Vitrasert during the first two months following implantation.

Other adverse events occurring at a rate of 1-5% in the Vitrasert clinical trials included: macular abnormalities, intraocular pressure spikes, optic disc / optic nerve changes, and hyphemas.

Please see full prescribing information for Vitrasert.