ganciclovir implant

ganciclovir implant

AIDS An ocular implant that delivers ganciclovir directly into the vitreous cavity in CMV retinitis. See Cytomegalovirus retinitis.
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In July 1995, Chiron Vision filed a New Drug Application (NDA) with the FDA based on two independent Phase III trials demonstrating that the Vitrasert ganciclovir implant offers significant improvement over deferred therapy or standard therapy in delaying the progression of CMV retinitis in the treated eye.
The difference in time to progression of retinitis for patients treated with the ganciclovir implant was remarkable, particularly when compared with the time to progression of two to three months reported with currently available systemic therapies," explained Daniel F.
In July 1995, Chiron Vision filed a New Drug Application (NDA) with the FDA based on two independent Phase III trials demonstrating that the Vitrasert ganciclovir implant offers significant improvement versus deferred therapy or standard therapy in delaying the progression of CMV retinitis in the treated eye.
The studies demonstrated that the Vitrasert ganciclovir implant offers a clinical improvement versus intravenous ganciclovir in further delaying progression of CMV retinitis in the treated eye.
Results of the NEI study, published in the December 14, 1994, issue of the Archives of Ophthalmology, showed that AIDS patients had no progression of newly diagnosed, peripheral CMV retinitis for about eight months using the ganciclovir implant.
The study found that in people who received immediate treatment (within 48 hours of enrollment) the ganciclovir implant eliminated all signs of active infection for a median of 226 days, or about eight months.
Currently, two additional clinical trials are underway to further evaluate the ganciclovir implant for CMV retinitis.
NASDAQ:CHIR), reported Tuesday that a Phase 3 clinical trial of its sustained-release intraocular ganciclovir implant demonstrated a clinically important improvement over intravenous ganciclovir in delaying the progression of cytomegalovirus (CMV) retinitis in AIDS patients.
The Chiron Vision study was one of two independent trials with favorable results on the intraocular ganciclovir implant presented at the National Conference on Human Retroviruses and Related Infections in Washington D.
Chiron Vision is analyzing data from the full cohort of 188 patients and expects to file an application with the United States Food and Drug Administration to market its intraocular ganciclovir implant following the completion of the data analysis.
CMV has been called the 'neglected disease of the AIDS pandemic', in part because of limited access to treatment, especially in the developing world, where localised intra-ocular ganciclovir implants and systemic oral valganciclovir are unavailable or too costly.
Currently the authors are unable to predict whether the 6-month outcomes reported here would have been better if state-of-the-art treatments such as ganciclovir implants and systemic valganciclovir had been available in our setting.