Fera Pharmaceuticals Announces FDA Approval of Avaclyr (acyclovir ophthalmic ointment)

The US Food and Drug Administration (FDA) has approved Fera's New Drug Application (NDA) for Avaclyr™ (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," noted Frank DellaFera, Fera's founder and President. "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 form¹. Fera is thankful to FDA for approving Avaclyr, making it available to physicians and patients in the US."

Fera launch plans include finalizing its selection of a commercialization partner to provide physicians and patients access to this important therapy.

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