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FDA Approves Ganciclovir Ophthalmic Gel for Herpetic Keratitis NEW YORK -- September 16, 2009 -- The US Food and Drug Administration (FDA) has approved ganciclovir ophthalmic gel (Zirgan) 0.15% for the treatment of herpetic keratitis. The FDA granted orphan drug designation for this indication in April 2007. The FDA approval was based on the results of 4 clinical trials comparing the efficacy and tolerability of ganciclovir ophthalmic gel with acyclovir ophthalmic ointment 3% in patients with herpetic keratitis. In 1 open label, randomised, controlled, multicentre trial which enrolled 164 patients with herpetic keratitis, ganciclovir ophthalmic gel was non-inferior to acyclovir in patients with dendritic ulcers. Clinical resolution (defined as percentage of healed ulcers) at day 7 was achieved in 77% of patients treated with ganciclovir ophthalmic gel versus 72% of patients treated with acyclovir. In 3 randomised, single-masked, controlled multicentre trials which enrolled 213 patients, ganciclovir ophthalmic gel was non-inferior to acyclovir. Clinical resolution at day 7 was achieved in 72% of patients treated with ganciclovir ophthalmic gel versus 69% of patients treated with acyclovir. SOURCE: Sirion Therapeutics, Inc. E-mail this page to a friend or colleague! To print, use this version