Ocular Herpes Simplex Virus Treatment Approved by FDA

Fera's Avaclyr (acyclovir ophthalmic ointment) 3% is a herpes simplex virus nucleoside analog DNA polymerase inhibitor

eye exam by an optometrist

The US Food and Drug Administration (FDA) has approved Avaclyr™ 3% for the treatment of herpetic keratitis. 

Herpes Simplex Virus (HSV) keratitis is a major cause of blindness, says the Center for Disease Control and Prevention (CDC).

Avaclyr (acyclovir ophthalmic ointment) 3%, is a herpes simplex virus nucleoside analog DNA polymerase inhibitor and 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. 

This is important news since there are no proven methods for preventing HSV keratitis. 

The FDA approved the New Drug Application (NDA) for Orphan drug and exclusivity was also granted, providing Fera Pharmaceutical 7 years of marketing exclusivity for Avaclyr. 

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Frank DellaFera, Fera’s founder and President, said in a press 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.” 

According to the CDC, HSV keratitis is an infection of the cornea 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. 

The Mayo Clinic offers some tips which may help to control HSV keratitis recurrences: 

  • Avoid touching your eyes or the area around your eyes unless you have washed your hands properly—especially if you have a cold sore or herpes blister. 
  • Only use eye drops that have been prescribed or recommended by an eye doctor or health care provider.

For more information visit FeraPharma.