Opening: Indication, Important Safety Information, and Contraindication

VUITY® (pilocarpine hydrochloride ophthalmic solution) 1.25% is indicated for the treatment of presbyopia in adults. VUITY® is contraindicated in patients with known hypersensitivity to any ingredient in the formulation.¹ Please see additional Important Safety Information later in the video.

Scene 1: What is Presbyopia?

Presbyopia is the progressive loss of accommodation which reduces the eyes ability to focus on nearby objects. It is an age-related process, usually appearing in individuals over 40.⁹

Scene 2: What is VUITY^®?

VUITY® (pilocarpine hydrochloride ophthalmic solution) 1.25% - the first and only FDA-approved eye drop specifically designed to treat presbyopia in adults. VUITY® improves near and intermediate vision without compromising distance vision.^1,10 Primary endpoint was the proportion of patients gaining ≥3 lines in mesopic, high-contrast, binocular distance-corrected near visual acuity (DCNVA) without losing more than 1 line (5 letters) of corrected distance visual acuity (CDVA) with the same refractive correction at Day 30, Hour 3.¹ Change from baseline in photopic, high-contrast, binocular distance-corrected intermediate visual acuity (DCIVA) at Day 30, Hour 3 was a prespecified secondary endpoint.¹⁰

Scene 3: pHast^TM technology

VUITY® is a reengineered formulation of pilocarpine delivered with pHast^TM technology.² Pilocarpine requires a low pH to maintain stability in the bottle.⁷ However, the ocular surface has a pH of around 7. Within seconds of contacting the ocular surface, pHast^TM technology allows VUITY® to rapidly adjust to the physiologic pH of the tear film.^2,4 A neutral pH was associated with increased corneal penetration, improving ocular bioavailability.^4-6

Scene 4: The Dual MOA of VUITY^®

VUITY® has a dual MOA. The primary MOA is extended depth of focus. The iris sphincter muscle contracts, constricting the pupil to improve near and intermediate visual acuity while maintaining some pupillary response to light. Secondarily, contraction of the ciliary muscle allows for increased amplitude of accommodation and may shift the eye to a more myopic state.¹

Scene 5: Important Safety Information, Warnings and Precautions

Miotics, including VUITY, may cause accommodative spasm. Patients should be advised not to drive or operate machinery if vision is not clear (e.g., blurred vision). In addition, patients may experience temporary dim or dark vision with miotics, including VUITY. Patients should be advised to exercise caution in night driving and other hazardous activities in poor illumination. Rare cases of retinal detachment and retinal tear have been reported with miotics, including VUITY. Individuals with pre-existing retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to the initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss. VUITY is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and lens. Contact lens wearers should be advised to remove their lenses prior to the instillation of VUITY and to wait 10 minutes after dosing before reinserting their contact lenses. To prevent eye injury or contamination, care should be taken to avoid touching the dispensing bottle to the eye or to any other surface.¹

Adverse Reactions: The most common adverse reactions (>5%) reported in clinical trials were headache and conjunctival hyperemia.¹