The FDA has approved Zirgan (ganciclovir ophthalmic gel, from Sirion Therapeutics) for the treatment of acute herpetic keratitis (dendritic ulcers). This approval was based on results from clinical trials comparing the efficacy and tolerability of Zirgan to acyclovir ophthalmic ointment 3% in patients with herpetic keratitis. In one open-label, randomized, controlled, multicenter clinical trial which enrolled 164 patients with herpetic keratitis, Zirgan 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% for Zirgan versus 72% for acyclovir. In three randomized, single-masked, controlled, multicenter clinical trials which enrolled 213 patients, Zirgan was noninferior to acyclovir in patients with dendritic ulcers. Clinical resolution at Day 7 was achieved in 72% for Zirgan versus 69% for acyclovir.
Zirgan is expected to be made available in early 2010 in a 0.15% strength ophthalmic gel.
For more information call (813) 496-7325 or visit www.siriontherapeutics.com.