Ocular herpes drug under FDA review

February 4, 2009

A New Drug Application (NDA) for ganciclovir ophthalmic gel 0.15% against herpetic keratitis, submitted by Sirion Therapeutics, Inc, has been accepted for review by the FDA.

A New Drug Application (NDA) for ganciclovir ophthalmic gel 0.15% against herpetic keratitis, submitted by Sirion Therapeutics, has been accepted for review by the FDA. The NDA for ganciclovir, which is already available in Europe under the brand name Virgan and has been given orphan drug designation in the US, has been given an action date of late 2009 by the FDA.

Sirion has conducted four randomized, multicentre clinical trials comparing ganciclovir with an established herpetic keratitis treatment - acyclovir ointment 3% - to determine safety and efficacy. The trials demonstrated that ganciclovir has a similar efficacy profile and an improved tolerability profile when compared with acyclovir.

If approved, ganciclovir would be the first new topical ophthalmic antiviral to be launched in the US in almost 30 years.