Doctors now have an additional option when managing herpes keratitis, as Fera Pharmaceuticals announced today that the FDA has approved its new drug Avaclyr. The product is an ophthalmic ointment containing acyclovir 3%. The company received orphan drug exclusivity, providing seven years of marketing exclusivity for the product.
The company describes Avaclyr as a herpes simplex virus nucleoside analog DNA polymerase inhibitor, indicated in the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus. The most common adverse reactions, which occurred in 2% to 10% of subjects, were eye pain (stinging), punctate keratitis and follicular conjunctivitis.
Fera says it is in the process of finalizing selection of a commercialization partner to provide doctors and patients access to Avaclyr.