Important Safety Information | Prescribing Information


*As demonstrated in a phase 3 open-label, randomized, controlled, multicenter clinical trial (N=164) in which patients with herpetic keratitis received either ZIRGAN or acyclovir ophthalmic ointment 3%, administered 5 times daily until healing of ulcer and then 3 times daily for 1 week. Clinical resolution (healed ulcers) at day 7 was achieved in 77% (55/71) of patients treated with ZIRGAN versus 72% (48/67) treated with acyclovir (difference, 5.8%; 95% CI, -9.6%-18.3%). ZIRGAN was noninferior to acyclovir in patients with dendritic ulcers.


See below for Indication and Important Safety Information.


INDICATION

ZIRGAN (ganciclovir ophthalmic gel) 0.15% is a topical ophthalmic antiviral that is indicated for the treatment of acute herpetic keratitis (dendritic ulcers).

IMPORTANT SAFETY INFORMATION

  • 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.

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

  • Safety and efficacy in pediatric patients below the age of 2 years have not been established.

Click here for Prescribing Information about ZIRGAN.


References: 1. Foster CS. Ganciclovir gel—a new topical treatment for herpetic keratitis. US Ophthalmic Rev. 2008;3(1):52-56. 2. ZIRGAN Prescribing Information, April 2014. 3. Croxtall JD. Ganciclovir ophthalmic gel 0.15% in acute herpetic keratitis (dendritic ulcers). Drugs. 2011;71(5):603-610.

ZGN.0065.USA.15