FDA OKs Acyclovir Ophthalmic Ointment

Officials with the US FDA have approved a new drug application (NDA) and orphan drug status for acyclovir ophthalmic ointment (Avaclyr^TM, Fera) 3% for the treatment of herpetic keratitis. Orphan drug status provides 7 years of marketing exclusivity for the product.

Avaclyr 3%, a herpes simplex virus nucleoside analog DNA polymerase inhibitor, is 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 (2-10%) reported in patients were eye pain (stinging), punctate keratitis and follicular conjunctivitis.

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

According to the CDC, HSV keratitis is an infection of the cornea—the clear dome that covers the colored part of the eye—that is caused by HSV. The infection usually heals without damaging the eye, but more severe infections can lead to scarring of the cornea or blindness. HSV keratitis is a major cause of blindness worldwide.^1,2,3

References

1. Liesegang TJ. Herpes simplex virus epidemiology and ocular importance. Cornea. 2001;20(1):1-13.

2. Center for Disease Control (CDC). https://www.cdc.gov/contactlenses/viral-keratitis.html#one. Accessed

April 1, 2019.

3. Avaclyr Package Insert December 2018