General Information

Vuity (pilocarpine hydrochloride ophthalmic solution) is a cholinergic muscarinic receptor agonist.

Vuity is specifically indicated for the treatment of presbyopia in adults.

Vuity is supplied as a solution. Instill one drop of Vuity in each eye once daily.

Mechanism of Action

Pilocarpine hydrochloride is a cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle. VUITY contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity while maintaining some pupillary response to light. VUITY also contracts the ciliary muscle and may shift the eye to a more myopic state.

Side Effects

Adverse effects associated with the use of Vuity may include, but are not limited to, the following:

• headache
• conjunctival hyperemia

Clinical Trial Results

The FDA approval of Vuity was based on data from two pivotal phase 3 clinical studies, GEMINI 1 and GEMINI 2, which evaluated the efficacy, safety and tolerability of Vuity for the treatment of presbyopia. A total of 750 participants aged 40 to 55 years old with presbyopia were randomized in the two studies in a one-to-one ratio of placebo to Vuity. Participants were instructed to administer one drop of Vuity or placebo once daily in each eye. Both studies met their primary endpoints with a statistically significant proportion of participants treated with Vuity gaining three lines (the ability to read three additional lines on a reading chart) or more in mesopic (in low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA), without losing more than 1 line (5 letters) of Corrected Distance Visual Acuity (CDVA) at day 30, hour 3, versus placebo.