FDA Approves Sirion’s New Drug Application For Zirgan

The FDA has approved Sirion Therapeutics’ (Sirion) New Drug Application for Zirgan (ganciclovir ophthalmic gel) 0.15% as a treatment for acute herpetic keratitis (dendritic ulcers). The FDA granted orphan drug designation to Zirgan for the indication in April 2007.

Reportedly, the FDA approval was based on the results of clinical trials, which compared the efficacy and tolerability of Zirgan to acyclovir ophthalmic ointment 3% in patients with herpetic keratitis.

In one open-label, randomised, controlled, multicenter clinical trial which enrolled 164 patients with herpetic keratitis, Zirgan was non-inferior to acyclovir in patients with dendritic ulcers. Clinical resolution at day 7 was achieved in 77% for Zirgan versus 72% (48/67) for acyclovir.

In three randomised, 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.

Barry Butler, CEO of Sirion, said: “The approval of Zirgan represents a true advance in topical antiviral therapies in the US. Up to the point, no therapy targeting only viral-infected cells was available for topical ocular use. Zirgan provides doctors with a much needed modern treatment for herpetic keratitis.”

Susan Benton, senior vice president of sales and marketing at Sirion, said: “We anticipate Zirgan will be commercially available to US physicians in early 2010. We’re pleased to introduce this important treatment option for herpetic keratitis to the US.”