The US Food and Drug Administration (FDA) has approved Fera’s New Drug Application (NDA) for AvaclyrTM (acyclovir ophthalmic ointment) 3% for the treatment of herpetic keratitis. Orphan drug exclusivity was also granted, providing seven years of marketing exclusivity for the product.
Avaclyr approval is a major milestone for the company. 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. Fera is thankful to FDA for approving Avaclyr, making it available to physicians and patients in the US,
noted Frank DellaFera,
Fera’s founder and President.
Fera launch plans include finalizing its selection of a commercialization partner to provide physicians and patients access to this important therapy.