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FDA Approves Avaclyr® for the Treatment of Herpes Simplex Dendritic Keratitis

Posted by Amanda Dexter on Apr 15, 2019 12:31:45 PM
Amanda Dexter
Dr. Amanda K. Dexter received her optometric training at Southern California College of Optometry in Fullerton, California, where she was Class of 2010 Valedictorian. She also completed a residency in Primary Care and Ocular Disease at the Veteran's Affairs Hospital in San Diego, California. Dr. Dexter is the Manager and Program Coordinator for OptoPrep, the premiere online study resource for the NBEO Part I & II.
FDA-Approves-Avaclyr®-for-the-Treatment-of-Herpes-Simplex-Dendritic-Keratitis 
On March 29, 2019, the U.S. Food and Drug Administration approved a new topical ophthalmic medication known as Avaclyr® for the treatment of herpes simplex dendritic keratitis.
 
Here is everything we know so far about the newest antiviral:
 

The Details:

Brand name: Avaclyr®
Generic name: Acyclovir
Dosage form: Ophthalmic ointment
Indication: Herpes simplex dendritic keratitis
Company: Fera Pharmaceuticals 
 

Mechanism of Action:

Acyclovir is a nucleoside analog that selectively inhibits the replication of herpes simplex virus (HSV) types 1 and 2 and varicella zoster virus. Following intracellular uptake of acyclovir, it is converted to acyclovir monophosphate by virally-encoded thymidine kinase.
 
It is important to note that this step does not occur to any significant degree in uninfected cells, and thereby lends specificity to the drug’s activity. The monophosphate derivative is subsequently converted to acyclovir triphosphate by cellular enzymes. Acyclovir triphosphate, in turn, competitively inhibits and inactivates HSV-specified DNA polymerases preventing further viral DNA synthesis without affecting normal cellular processes. 
 

Dosage:

Avaclyr® ophthalmic ointment is applied as a 1cm ribbon to the inside of the lower eyelid of the affected eye five times per day until the corneal ulcer has healed. Its usage is then decreased to three times per day for seven more days. 
 

Side Effects:

The most common adverse reactions reported in clinical trials of patients using Avaclyr® were eye pain (stinging) upon instillation, punctate keratitis, and follicular conjunctivitis. 

Why Avaclyr® ?

 
Frank DellaFera (Fera Pharmaceuticals founder and President) stated that the reason his company decided to pursue approval of Avaclyr® was because “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.” 
 

When Can We Rx Avaclyr® ?

 
Fera Pharmaceuticals’ launch plans for Avaclyr® include finalizing its selection of a commercialization partner to provide physicians and patients access to this therapy. It is unknown at this time when Avaclyr® will available to prescribe. 
 
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Topics: Drug Updates

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