1.25%
Pilocarpine
An optimized formulation for presbyopia
Designed to balance efficacy, safety, and tolerability.1,2
Studied
16
Investigational
Formulations
Initially evaluated in two Phase 2b trials2
Tested
>1,000
participants
Tested across Phase 2 studies 009 (N=157) and 010 (N=147), and Phase 3 trials GEMINI 1 (N=323) and GEMINI 2 (N=427)1,2
Evaluated
Mesopic +
photopic
CONDITIONS
Evaluated in both low light (mesopic) and bright light (photopic) conditions in Phase 3 studies3
Arrived at
Optimized concentration for presbyopia1,2
Delivered with pHastTM technology2
A proprietary vehicle that rapidly adjusts pH and increases corneal penetration*†2,4-6
†Based on an in vitro study. Clinical significance is unknown.
* The pH range of VUITYTM in the bottle is between 3.5 and 5.5.1
Shelf-stable pH
All pilocarpine, including VUITY™, is stored at low pH (~pH 4.5) for stability.*7
* The pH range of VUITY™ in the bottle is between 3.5 and 5.5.1
* The pH range of VUITY™ in the bottle is between 3.5 and 5.5.1
‡The physiological pH of tears (~pH 6.5) was achieved within 60 seconds.4
Rapidly adjusts pH
Within seconds of contacting the ocular surface, VUITY™ starts to adjust to the physiological pH (~pH 6.5) of the tear film.†‡2,4
‡The physiological pH of tears (~pH 6.5) was achieved within 60 seconds.4
With increased corneal penetration†
A neutral pH was associated with increased corneal penetration, improving ocular bioavailability.4-6
Dual mechanism of action1
Pilocarpine hydrochloride is a cholinergic muscarinic agonist that activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle.1
Primary:
Extends depth of focus
VUITY™ contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity while maintaining some pupillary response to light.
Secondary:
Increases the amplitude of accommodation§
VUITY™ also contracts the ciliary muscle and may shift the eye to a more myopic state.
§Accommodation is the ability of the eye to change the refractive power of the lens to automatically focus on objects at various distances. Amplitude of accommodation (AA) is the amount of accommodation exerted to move the focus from the far point to the near point.9