FDA approves Sirion's NDA for ganciclovir 0.15% for herpetic keratitis

October 2, 2009

The FDA has approved a new drug application (NDA) for ganciclovir ophthalmic gel 0.15% (Zirgan, Sirion Therapeutics) as a treatment for acute herpetic keratitis (dendritic ulcers), the company announced.

Tampa, FL

-The FDA has approved a new drug application (NDA) for ganciclovir ophthalmic gel 0.15% (Zirgan, Sirion Therapeutics) as a treatment for acute herpetic keratitis (dendritic ulcers), the company announced. Sirion expects the drug to be commercially available to U.S. physicians early next year.

“Up to this point, no therapy targeting only viral-infected cells was available for topical ocular use” in the United States, said Barry Butler, chief executive officer of Sirion.

The agency had granted orphan drug designation to the gel for this indication in April 2007. The NDA approval was based on the results of clinical trials conducted by Laboratoires Théa of France in Europe, Asia, and Africa that compared the efficacy and tolerability of ganciclovir 0.15% gel with acyclovir 3% ointment in patients with herpetic keratitis, according to the company. Both ganciclovir gel and acyclovir ointment, which are standard-of-care therapies outside of the United States, selectively target the replication of herpes simplex virus DNA.

In one open-label, randomized, controlled, multicenter clinical trial that enrolled 164 patients with herpetic keratitis, ganciclovir was found to be 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 (55/71) using ganciclovir versus 72% of patients (48/67) using acyclovir.

In three randomized, single-masked, controlled, multicenter clinical trials that enrolled 213 patients, ganciclovir was found to be non-inferior to acyclovir in patients with dendritic ulcers. Clinical resolution at day 7 was achieved in 72% of patients (41/57) using ganciclovir versus 69% of patients (34/49) using acyclovir.

The recommended dosing regimen for ganciclovir 0.15% is one drop in the affected eye five times per day until the ulcer heals, then one drop three times per day for 7 days. The gel will be supplied in 5-gram tubes and will be available by prescription.