VUITY, an FDA-approved eye drop for presbyopia, has significant market potential given the growing aging population. With an estimated 128 million Americans affected by presbyopia, VUITY offers a convenient, non-invasive alternative to reading glasses. Its adoption could expand as awareness rises and consumers seek lifestyle-friendly vision correction options.
LAS VEGAS, March 26, 2025 /PRNewswire/ -- DelveInsight's "VUITY Market Size, Forecast, and Market Insight Report" highlights the details around VUITY, which is a miotic, 1.25% pilocarpine hydrochloride ophthalmic solution prescribed to treat presbyopia in adults. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of VUITY. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
AbbVie's VUITY (pilocarpine hydrochloride ophthalmic solution) Overview
VUITY, developed by Allergan (now part of AbbVie), is a 1.25% pilocarpine hydrochloride ophthalmic solution designed to treat presbyopia in adults. It acts as a cholinergic muscarinic receptor agonist and comes as a sterile, isotonic, colorless solution. The active ingredient, pilocarpine hydrochloride, stimulates muscarinic receptors in smooth muscles such as the iris sphincter and ciliary muscle. This leads to contraction of the sphincter muscle, causing pupil constriction to enhance near and intermediate vision while preserving some light response. Additionally, it contracts the ciliary muscle, shifting the eye to a more myopic state.
VUITY's approval was based on two key Phase III trials, GEMINI 1 and GEMINI 2, which showed that it improved near and intermediate vision without compromising distance vision by helping the eye naturally reduce pupil size. It is the first and only US FDA-approved eye drop for presbyopia, a condition affecting nearly half of the US adult population. The drops are administered once daily using a proprietary PhAST technology, which enables quick adaptation to the eye's natural pH.
In March 2023, the FDA approved a supplemental New Drug Application (sNDA) for VUITY, allowing for a second dose (one drop in each eye) to be applied 3 to 6 hours after the initial dose for enhanced presbyopia treatment in adults. The recommended dosage is one drop in each eye once daily, with the option for a second dose within the 3 to 6-hour window. VUITY contains 12.5 mg/mL of pilocarpine hydrochloride and is provided as a clear, sterile solution.
Drug Name | VUITY (pilocarpine hydrochloride ophthalmic solution) |
Approved Year | US: 2021 |
Molecule type | Small molecule |
Developer | AbbVie |
Indication | Presbyopia in adults |
Mechanism of action | Muscarinic receptor agonist |
Route of administration | Ophthalmic solution |
Learn more about VUITY projected market size for presbyopia @ VUITY Market Potential
Presbyopia is a common age-related vision problem characterized by a gradual decline in the ability to see up close, typically developing between the ages of 40 and 60. It occurs due to the lens losing its elasticity and becoming thicker, harder, and less flexible because of changes in structural proteins.
This reduces the lens's ability to adjust focus for near vision, leading to diminished accommodative amplitude. Presbyopia can be categorized into incipient, functional, absolute, premature, and nocturnal types, reflecting different stages and symptoms of the condition. According to DelveInsight, approximately 325 million cases of presbyopia were reported in the 7MM in 2023. This number is projected to grow at a notable CAGR of 1.1% from 2024 to 2034.
Treatment options primarily include corrective lenses and surgical procedures. Non-invasive solutions like reading glasses, bifocals, and progressive lenses improve vision at varying distances. Contact lenses, including multifocal and monovision types, provide another alternative. Surgical options such as LASIK, conductive keratoplasty, and corneal inlays adjust the eye's focusing ability. Recently, eye drops like pilocarpine hydrochloride have emerged as a promising treatment, temporarily enhancing near vision by constricting the pupil to increase depth of field.
DelveInsight projects that the presbyopia market size, valued at around USD 17 billion in 2023, is expected to grow at a CAGR of 3.2% by 2034. This growth is driven by improvements in treatment options, better healthcare access, and a rising number of cases, fueling demand for more advanced and effective therapies.
Discover more about the presbyopia market in detail @ Presbyopia Market Report
Emerging Competitors of VUITY
The presbyopia treatment landscape began to evolve with the approval of QLOSI (PresbiDrops (CSF-1)) in 2023, joining VUITY (pilocarpine hydrochloride ophthalmic solution) as the only FDA-approved therapies. Despite these approvals, the market remains underdeveloped, with limited competition on the horizon.
Key pipeline candidates include LNZ100 (Lenz Therapeutics) and BRIMOCHOL PF (Visus Therapeutics and Tenpoint Therapeutics), both seeking to address these unmet needs. LNZ100's NDA has been accepted by the FDA, with a PDUFA date of August 8, 2025, and no advisory committee meeting scheduled. BRIMOCHOL PF is expected to file its NDA in the first half of 2025, aiming for a US commercial launch in the first half of 2026 following anticipated FDA approval.
With only two approved therapies and a relatively weak pipeline, there remains a substantial market opportunity for new treatments that offer better efficacy, longer-lasting effects, or greater patient convenience.
To know more about the number of competing drugs in development, visit @ VUITY Market Positioning Compared to Other Drugs
Key Milestones of VUITY
- In 2022, AbbVie submitted an sNDA to the US FDA for an optional twice-daily administration of VUITY for the treatment of presbyopia in adults, based on the Phase III Virgo trial results, which improved near vision without compromising distance vision at hour 9 (3 hours after the second drop).
- In May 2020, AbbVie, a research-based global biopharmaceutical company, completed its acquisition of Allergan following the receipt of regulatory approval from all government authorities required by the transaction agreement and approval by the Irish High Court.
- In October 2021, the US FDA approved VUITY to treat presbyopia, commonly known as age-related blurry near vision, in adults.
- In April 2020, the US Patent and Trademark Office granted a patent to use VUITY for the treatment of presbyopia. The patent is anticipated to expire by April 2039.
Discover how VUITY is shaping the presbyopia treatment landscape @ VUITY Eye Drops
VUITY Market Dynamics
VUITY holds a first-mover advantage as the first FDA-approved eye drop for presbyopia, giving it an established market presence and significant brand recognition among ophthalmologists and patients, which positions it as the go-to option before new entrants establish themselves. The largely underserved presbyopia market, with only one additional FDA-approved therapy (QLOSI) and a weak pipeline of emerging competitors, creates a significant growth opportunity for VUITY to expand its market share by leveraging its established position, enhancing formulations, or exploring additional indications.
However, VUITY's short duration of action (up to six hours) may limit its appeal for some patients seeking all-day vision correction, potentially reducing adherence or satisfaction. Furthermore, the entry of pipeline candidates like LNZ100 and BRIMOCHOL PF, which may offer longer duration, improved efficacy, or better tolerability, poses a competitive threat, requiring VUITY to adopt strategic efforts such as lifecycle management, pricing strategies, and physician engagement to maintain its market dominance.
Dive deeper to get more insight into VUITY's strengths & weaknesses relative to competitors @ VUITY Market Drug Report
Table of Contents
1 | Report Introduction |
2 | VUITY: AbbVie |
2.1 | Product Overview |
2.2 | Other Development Activities |
2.3 | Clinical Development |
2.4 | Clinical Trials Information |
2.5 | Safety and Efficacy |
2.6 | Product Profile |
2.7 | Market Assessment |
2.7.1 | The 7MM Analysis |
2.7.1.1 | Cost Assumptions and Rebate |
2.7.1.2 | Pricing Trends |
2.7.1.3 | Analogue Assessment |
2.7.1.4 | Launch Year and Therapy Uptake |
2.7.2 | The United States Market Analysis |
2.7.3 | EU4 and the United Kingdom Market Analysis |
2.7.3.1 | Germany |
2.7.3.2 | France |
2.7.3.3 | Italy |
2.7.3.4 | Spain |
2.7.3.5 | UK |
2.7.4 | Japan Market Analysis |
2.8 | Market Drivers |
2.9 | Market Barriers |
2.10 | SWOT Analysis |
3 | Key Cross of Marketed Competitors of VUITY |
4 | Key Cross of Emerging Competitors of VUITY |
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