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Vuity FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 10, 2021.

FDA Approved: Yes (First approved October 28, 2021)
Brand name: Vuity
Generic name: pilocarpine hydrochloride
Dosage form: Ophthalmic Solution
Company: AbbVie Inc.
Treatment for: Presbyopia

Vuity (pilocarpine hydrochloride) is an optimized ophthalmic solution formulation of the approved cholinergic muscarinic receptor agonist pilocarpine indicated for the treatment of presbyopia (age-related blurry near vision).

  • Presbyopia is caused when the lens of the eye can't change shape to focus light correctly on the retina, making it difficult to focus on near objects.
  • Vuity works by activating the muscarinic receptors to contract the iris sphincter muscle in the eye. This constricts the pupil, while still maintaining some pupillary response to light.
  • Vuity is administered by instilling one drop into each eye once daily. It works in as early as 15 minutes and lasts up to 6 hours to improve near and intermediate vision without impacting distance vision. 
  • Patients using Vuity should be aware of undertaking hazardous activities in poor light such as night driving. Rare cases of retinal detachment have been reported in patients using other miotics, so patients using Vuity are advised to seek immediate medical care if they experience sudden onset of vision loss.
  • Common adverse reactions include headache and conjunctival hyperemia.

Development timeline for Vuity

Oct 29, 2021Approval FDA Approves Vuity (pilocarpine HCI ophthalmic solution) to Treat Presbyopia (Age-Related Blurry Near Vision)
Oct 26, 2021Allergan, an AbbVie Company, to Present New Data on Investigational AGN-190584 for the Treatment of Presbyopia
Jul 25, 2021New Data Presented on the Safety and Efficacy of Investigational AGN-190584 as a Potential Novel Treatment for Presbyopia, a Common and Progressive Eye Condition
Feb 25, 2021Allergan Submits New Drug Application for Investigational AGN-190584 for the Treatment of Presbyopia

Further information

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