Zirgan

Generic Name: ganciclovir ophthalmic gel
Date of Approval: September 15, 2009
Company: Sirion Therapeutics, Inc.

Treatment for: Herpetic Keratitis

FDA Approves Zirgan

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The US Food and Drug Administration (FDA) has approved its New Drug Application for Zirgan (ganciclovir ophthalmic gel) 0.15% as a treatment for acute herpetic keratitis (dendritic ulcers).

The FDA 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 Zirgan to acyclovir ophthalmic ointment 3% in patients with herpetic keratitis. Both ganciclovir gel and acyclovir ointment are standard-of-care therapies outside of the US, and selectively target the replication of HSV DNA, unlike older antivirals which affect both healthy and infected cells.

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% (55/71) for Zirgan versus 72% (48/67) for acyclovir.

In three randomized, single-masked, controlled, multicenter clinical trials which enrolled 213 patients, Zirgan was non-inferior to acyclovir in patients with dendritic ulcers. Clinical resolution at Day 7 was achieved in 72% (41/57) for Zirgan versus 69% (34/49) for acyclovir.

What is Zirgan?

Zirgan is a topical ophthalmic antiviral that is indicated for the treatment of acute herpetic keratitis (dendritic ulcers).

How should I use Zirgan?

The recommended dosing regimen for Zirgan is 1 drop in the affected eye 5 times per day until the ulcer heals, and then 1 drop 3 times per day for 7 days.

You should not allow the dropper tip to touch any surface, as this may contaminate the gel.

If pain develops, or if redness, itching, or inflammation becomes aggravated, you should consult a physician.

Important information about Zirgan

Zirgan is indicated for topical ophthalmic use only.

Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with Zirgan.

Zirgan Side Effects

The most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

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