Rx Pharmaceuticals
Vitrasert® (ganciclovir intavitreal implant) 4.5 mg
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 intravenous treatment. Data from Bausch & Lomb Surgical's Phase III trial of 188 AIDS patients with newly diagnosed CMV Retinitis have 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 Vitrasert implant contains ganciclovir embedded in a polymer-based system that slowly releases the drug. The implant, surgically placed in the posterior segment of the eye, allows diffusion of the drug locally to the site of infection over an extended period of months.
Implantation normally takes less than one hour, requires only local anesthesia, and is conducted in an outpatient, day-surgery setting.
Immediately following insertion of the implant, most patients experience transient blurred vision in the operated eye, which generally clears within two to four weeks. The implant can be removed when depleted of drugs, usually within five to eight months, and a new Vitrasert implant can be inserted.
Please see package insert for prescribing and safety information.
