FDA Approves Ganciclovir Ophthalmic Gel for Dendritic Ulcers

Yael Waknine

September 16, 2009

September 16, 2009 — The US Food and Drug Administration (FDA) has approved ganciclovir 0.15% ophthalmic gel (Zirgan, Sirion Therapeutics, Inc) for the treatment of acute herpetic keratitis, also known as dendritic ulcers.

Dendritic ulcers are caused by the herpes simplex virus and represent the leading indication for corneal transplantation in the United States. Recurrent flaring of the latent corneal infection results in scarring and inflammation, increasing the risk for blindness.

The FDA's action was based on data from an open-label, randomized clinical trial (n = 164) and 3 randomized, single-blind studies (n = 213) conducted in Europe and Asia, showing that ganciclovir 0.15% ophthalmic gel was noninferior to acyclovir 3% ophthalmic ointment for achieving clinical resolution of dendritic ulcers at day 7 (77% vs 72% and 72% vs 69%, respectively). Both are standard-of-care therapies outside of the United States and selectively target herpes simplex virus DNA replication.

"The approval of Zirgan represents a true advance in topical antiviral therapies in the US," commented Barry Butler, chief executive officer of Sirion in a company news release. "Up to this 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."

The recommended dosing regimen for ganciclovir ophthalmic gel is 1 drop instilled in the affected eye 5 times daily until the ulcer heals, and then 1 drop 3 times daily for 7 days. Adverse events most commonly reported in clinical trials included blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

Ganciclovir ophthalmic gel previously was granted orphan drug status by the FDA.