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Avaclyr FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on April 3, 2019.

FDA Approved: Yes (First approved March 29, 2019)
Brand name: Avaclyr
Generic name: acyclovir
Dosage form: Ophthalmic Ointment
Company: Fera Pharmaceuticals
Treatment for: Herpes Simplex Dendritic Keratitis

Avaclyr (acyclovir ophthalmic ointment) is a herpes simplex virus nucleoside analog DNA polymerase inhibitor indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus.

  • Herpetic keratitis is an infection of the cornea that is caused by the herpes simplex virus.
  • Avaclyr ophthalmic ointment is applied as a 1 cm ribbon to the inside of the lower lid of the affected eye five times per day until the corneal ulcer is healed, then three times per day for seven days.
  • The most common adverse reactions reported in patients using Avaclyr were eye pain (stinging), punctate keratitis and follicular conjunctivitis.

Development Timeline for Avaclyr

Apr  1, 2019ApprovalFDA Approves Avaclyr (acyclovir ophthalmic ointment) for the Treatment of Herpetic Keratitis

Further information

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