Vuity®
Pilocarpine 1.25% · ophthalmic solution
Aesthetics/Presbyopia
Approved uses
Presbyopia
One drop in each eye once daily, with an optional second drop in each eye 3 to 6 hours later
Near vision improves within 15 minutes; the 3-line gain is no longer significant by hour 8.
Presbyopia after LASIK or PRK
One drop in each eye once daily, with an optional second drop in each eye 3 to 6 hours later
After prior LASIK or PRK, the near-vision gain holds only through about 3 hours.
Contraindications
Known hypersensitivity to pilocarpine hydrochloride or to any excipient.
Available FormsPilocarpine hydrochloride 1.25% solution, 2.5 mL fill in a 5 mL bottle (carton of 1 or box of 3), 5 mL fill in a 5 mL bottle
Mechanism of ActionCholinergic muscarinic agonist that contracts the iris sphincter, constricting the pupil to improve near and intermediate acuity while some pupillary response to light is retained. It also contracts the ciliary muscle and may shift the eye to a more myopic state.
Warnings & Precautions
- Retinal tear and detachment: Rare reports with miotics, including this product; pre-existing retinal disease raises the risk, so retinal examination is advised before initiation, with immediate care for sudden flashing lights, floaters, or vision loss. A propensity-matched real-world cohort of topical pilocarpine users found 1 year rhegmatogenous detachment 0.78% versus 0.33% on artificial tears (RR 2.33, 95% CI 1.28 to 4.27).
- Accommodative spasm: Miotics may cause it; no driving or machinery while vision is not clear.
- Dim or dark vision: Temporary with miotics; caution with night driving and other hazardous activity in poor illumination.
- Iritis: Use is not recommended while iritis is present, since synechiae may form between the iris and the lens.
- Bottle contamination and eye injury: Avoid touching the dispensing bottle to the eye or any other surface.
Common Side Effects
- Ocular, once daily dosing: Conjunctival hyperemia over 5%; blurred vision, eye pain, visual impairment, eye irritation, and increased lacrimation each 1 to 5% (GEMINI 1 and 2, 30 days).
- Ocular, twice daily dosing: Eye irritation over 5%; visual impairment, eye pain, blurred vision, and vitreous floaters each 1 to 5% (VIRGO, two doses 6 hours apart, 14 days).
- Systemic: Headache over 5%, the most common reaction in both the once daily and twice daily programs.
- Postmarketing eye disorders: Vitreous detachment, vitreomacular traction, retinal tear, retinal detachment; frequency not estimable from spontaneous reports.
Pregnancy & LactationPregnancy: No adequate and well-controlled studies in pregnant women; oral dosing of pregnant rats produced no adverse effects at clinically relevant doses, with maternal toxicity, skeletal anomalies, and reduced fetal weight at roughly 485 times the maximum human ophthalmic dose, increased stillbirths at roughly 195 times, and decreased neonatal survival at roughly 100 times.
Lactation: No information on pilocarpine in human milk; it is excreted in rat milk, and systemic levels after topical ocular dosing are low.
Pediatric UsePresbyopia does not occur in the pediatric population.