VUITY™ is an ophthalmic solution containing 1.25% pilocarpine hydrochloride as the active ingredient. Developed by AbbVie, it was approved by the U.S. FDA in October 2021 for the treatment of presbyopia in adults. It is the first FDA-approved ophthalmic solution worldwide for the treatment of presbyopia.
Presbyopia is a condition in which the elasticity of the lens decreases with age, leading to a loss of accommodative ability and difficulty seeing near objects. Approximately 25% of the world’s population (about 1.8 billion people) is affected by presbyopia, making it a universal age-related change that everyone experiences at some point1).
In the teenage years, accommodative power is 12–14 diopters, but it begins to decline rapidly around age 40, dropping to about 1 diopter in the 50s. When the near point distance exceeds 40 cm, symptoms of presbyopia appear, making it difficult to see nearby objects and requiring reading glasses.
VUITY™ uses a unique buffer solution called “pHast™ technology” that rapidly adapts to the physiological pH of the tear film after instillation, thereby enhancing bioavailability and reducing side effects.
As of March 2026, VUITY is not approved in Japan. Personal importation may be legally possible in some cases, but using it without a doctor’s prescription and supervision carries risks. For the treatment of presbyopia, it is recommended to consult an ophthalmologist.
The initial symptoms of presbyopia are eye fatigue during near vision and decreased visual acuity in the evening. Significant difficulty in near vision often becomes apparent after age 45.
Pathophysiology of Presbyopia
Decreased accommodative power: Due to reduced elasticity of the lens nucleus, the lens cannot thicken even when the ciliary muscle contracts.
Increased near point distance: When accommodative power falls to about 2D or less, the near point distance becomes 50 cm or more, making it difficult to see close objects.
Depth of focus: With aging, the pupil diameter decreases, and a compensatory mechanism naturally deepens the depth of focus along with miosis.
Findings after VUITY administration
Pupillary constriction (miosis): One hour after administration, the pupil diameter decreases from approximately 3.4 mm to about 1.9 mm1).
Improved near vision: Depth of focus increases, improving near vision. The effect appears within 15 minutes and lasts for 6 hours.
Effect on distance vision: With appropriate miosis (2.0–2.5 mm), adverse effects on distance vision are minimized1).
Presbyopia is not a disease but a physiological age-related change that occurs in everyone. The main cause is decreased elasticity of the lens, while the function of the ciliary muscle is preserved to some extent. The goal of treatment is to compensate for the loss of accommodative power optically or pharmacologically.
The main cause of presbyopia is age-related loss of lens elasticity (nuclear sclerosis). Even when the ciliary muscle contracts and relaxes the zonular fibers, the hardened lens cannot change its curvature. Accommodative power of the lens is almost completely lost after age 50.
Risk factors that influence the onset and progression of presbyopia are as follows:
Presbyopia is diagnosed through patient interview, refraction test, and accommodation test.
| Test item | Purpose |
|---|---|
| Near point distance measurement | Quantification of accommodative amplitude |
| Near visual acuity test | Assessment of functional visual acuity |
| Accommodation function analysis | Objective evaluation of ciliary muscle activity |
In the evaluation of VUITY indication, dilated fundus examination is also recommended to assess the risk of retinal detachment (especially in myopic eyes and vitreous degeneration).
For the correction and treatment of presbyopia, there are optical correction, pharmacotherapy, and surgical therapy.
VUITY (pilocarpine 1.25% ophthalmic solution) is an FDA-approved pharmacotherapy for presbyopia in adults.
Dosage and Administration:
Onset and duration of effect:
The effect of VUITY lasts about 6 to 10 hours per instillation, but it does not provide all-day use without sacrificing distance vision like reading glasses do. Decreased vision in dim light and effects on night driving have also been reported. At present, it does not completely replace reading glasses, and complementary use is realistic.
Presbyopia is primarily caused by a decline in accommodative function due to decreased elasticity of the lens. Accommodative power, which is about 12 diopters in the teenage years, decreases to approximately 5 diopters at age 40 and to around 1 diopter in the 50s.
The main cause of reduced accommodative power is decreased elasticity of the lens nucleus, while the contractile force of the ciliary muscle is thought to remain largely intact. An increase in higher-order aberrations with age is also considered a contributing factor to the subjective amplitude of accommodation.
With aging, the pupil diameter decreases (senile miosis), which acts as a compensatory mechanism to deepen the depth of focus. At a pupil diameter of 3 mm, the depth of focus is approximately 0.5 to 0.7 D.
Pilocarpine is a direct-acting muscarinic receptor agonist that directly acts on the intraocular smooth muscles of the iris and ciliary body.
Action on the iris sphincter muscle: The iris sphincter muscle contracts, causing miosis. Miosis produces a pinhole effect (aperture optics), which increases the depth of focus. This is the main mechanism for improving near vision 1).
Action on the ciliary muscle: Contraction of the ciliary muscle relaxes the tension of the zonular fibers, causing the lens to become thicker. This may contribute to an additional accommodative effect.
According to an integrated analysis of optical modeling and clinical trial results, the optimal pupil diameter after miosis is approximately 2.0–2.5 mm, which provides the best balance between increased depth of focus and retinal illuminance1). One hour after administration of 1.25% pilocarpine (VUITY), the pupil diameter decreases from an average of 3.4 mm to about 1.9 mm1).
De Gracia & Pucker (2025) integrated optical modeling with clinical trial data of pilocarpine-based drugs and concluded that a pupil diameter of 2.0–2.5 mm, achievable through pharmacological miosis, provides the optimal balance between increased depth of focus and retinal illuminance under photopic and mesopic conditions1).
The half-life of pilocarpine in the aqueous humor has been shown to be approximately 31.83 minutes.
GEMINI 1 and 2 trials (basis for FDA approval): A 30-day phase III double-blind randomized controlled trial involving 750 presbyopic patients aged 40–55 years.
VIRGO trial (twice-daily dosing): A phase III study involving 230 participants. In the twice-daily dosing group, 35.1% achieved the primary endpoint compared to 7.8% in the placebo group2).
In a randomized phase 2b trial by Farid et al. (166 participants, aged 45–64 years), on day 15 of treatment with 0.4% pilocarpine (CSF-1) alone, the rate of achieving a 3-line improvement was 46.9% (CSF-1 group) vs. 16.1% (control group), demonstrating statistically significant superiority (P = 0.0002). The 0.2% pilocarpine did not meet the primary endpoint, and 0.4% was identified as the minimum effective concentration2).
0.4% pilocarpine (Qlosi; Orasis Pharmaceuticals) was approved by the FDA in 2023. Compared to 1.25%, it induces more gradual miosis (post-dose pupil diameter approximately 2.3 mm), improving near vision while minimizing vision loss under low-light conditions1).
Ciliary muscle contraction due to miosis may theoretically increase the risk of retinal detachment in myopic patients. No retinal detachment was observed during the GEMINI 1 and 2 trials, but case reports of vitreomacular traction, retinal tear, and retinal detachment have been reported after FDA approval.
A retrospective review of thousands of cases over 40 years showed a 3.14-fold increased risk of rhegmatogenous retinal detachment in patients using pilocarpine eye drops (though the incidence was less than 1%).
Waring et al. (2024) evaluated the effect of 1.25% pilocarpine on nighttime driving performance and reported that even with reduced light entry due to miosis, nighttime driving maintained an “acceptable level” 1). However, if miosis is too strong (<2.0 mm), the risk of decreased visual acuity in dark conditions increases 1).
In patients after refractive surgery (post-LASIK/PRK) or corneal transplantation (post-DMEK), optical correction techniques continue to be refined. Cases have been reported where secondary implantation of an auxiliary trifocal intraocular lens into the ciliary sulcus achieved presbyopia correction without affecting the fundus or cornea in patients with a monofocal intraocular lens after DMEK 4). Additionally, in patients after Intracor (intrastromal femtosecond laser treatment), a combination of a small-aperture intraocular lens (IC-8) and a non-diffractive EDOF intraocular lens has been shown to be effective in some cases 3).
Optical modeling (Visual Strehl Ratio of the Optical Transfer Function: VSOTF) and integrated clinical research for optimizing miosis size are progressing, and the theoretical basis for drug concentration design targeting a miosis diameter of 2.0–2.5 mm is being established 1). Developing individualized dosing strategies tailored to each patient’s pupil diameter characteristics and usage environment (bright/dark conditions) is a future challenge.
It does not always occur. The risk of retinal detachment is reported to be less than 1%, but the relative risk increases in patients with myopia, lattice degeneration, or vitreous liquefaction. Before using VUITY, it is important to undergo a fundus examination by an ophthalmologist and receive a thorough explanation of the risks.
