The FDA has approved a new drug application for Avaclyr, Fera Pharmaceuticals’ herpetic keratitis treatment, according to a press release.
Avaclyr (acyclovir ophthalmic ointment 3%), a herpes simplex virus nucleoside analog DNA polymerase inhibitor, is indicated to treat dendritic ulcers in patients with HSV-1 and HSV-2, the release said.
In addition, Avaclyr was granted orphan drug exclusivity.
“Avaclyr approval is a major milestone for the company,” Frank DellaFera, Fera’s founder and president, said in the release. “Working closely with the eye care community we were able to identify a need for additional options to treat herpetic keratitis. Acyclovir is the gold standard treatment in herpes virus infections, so it made sense to provide this therapy in an ophthalmic dosage form.”