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FDA approves topical treatment for acute herpetic keratitis
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TAMPA, Fla. — The U.S. Food and Drug Administration has approved ganciclovir ophthalmic gel 0.15% as a topical treatment for acute herpetic keratitis, drug developer Sirion Therapeutics announced in a press release.
Zirgan (ganciclovir ophthalmic gel 0.15%), also available in Europe under the trademark Virgan, is the first innovation in the U.S. topical ophthalmic antiviral class of drugs in almost 30 years, according to the release.
Ganciclovir gel 0.15% and acyclovir ointment 3%, standard treatments for herpetic keratitis outside the U.S., target the replication of herpes simplex virus DNA. Earlier antiviral agents affected healthy and infected cells.
Approval was based on results of clinical trials conducted in Europe, Asia and Africa that showed ganciclovir ophthalmic gel to be comparable to acyclovir ophthalmic ointment in treating herpetic keratitis.
An open-label, randomized multicenter clinical trial with 164 patients showed clinical resolution of herpetic ulcers at 7 days in 77% of patients using ganciclovir ophthalmic gel compared with 72% of patients treated with acyclovir ointment, the release said.
Three randomized, masked clinical trials with 213 patients showed clinical resolution of ulcers at 7 days in 72% of patients treated with ganciclovir and 69% of patients treated with acyclovir, the release said.
Zirgan is expected to enter the U.S. commercial market in early 2010, according to the release.
Zirgan is a trademark of Laboratoires Thea of France. Sirion owns exclusive rights to develop and market the drug in the U.S.