Dry Eye Disease Market Outlook 2034 – Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

Dry Eye Disease Market

Dry Eye Disease Market Summary

In 2023, the Dry Eye Disease (DED) market size across the 7MM reached ~USD 3.76 billion, with the US leading at USD 2.74 billion and ~22.5 million diagnosed cases. Prevalence and market size are projected to rise by 2034.

• Japan: ~2.3M males and ~8.3M females affected in 2023, expected to increase.
• UK: ~2.8M mild, ~1.3M moderate, and ~2.0M severe cases in 2023, all anticipated to grow.

Current treatment landscape includes VEVYE, TYRVAYA, EYSUVIS, CEQUA, off-label therapies, and eye drops. Future growth will be driven by the launch of emerging therapies (2024–2034).

DelveInsight’s “Dry Eye Disease Market Insights, Epidemiology, and Market Forecast–2034” provides a comprehensive analysis of Dry Eye Disease, including historical and projected epidemiology, along with market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. The report highlights emerging therapies, current treatment approaches, therapy-wise market share, and market size projections from 2020 to 2034. It further examines treatment algorithms, key market drivers and barriers, and existing unmet needs, helping identify growth opportunities and evaluate the market’s overall potential.

To know in detail about the Dry Eye Disease market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Dry Eye Disease Market Forecast

Some of the key facts of the Dry Eye Disease Market Report:

• In May 2025, AbbVie announced a study in which Stage 1 evaluated the safety of AGN-242428 and AGN-231868, how well they are tolerated, and how they move through the body when administered. After the sponsor’s determination of adequate safety and tolerability of the interventions in Stage 1, Stage 2 began. Stage 2 also evaluated the safety and tolerability of AGN-242428 and AGN-231868, how effective they are in treating dry eye disease (DED), and assessed the plasma and tear exposure of both ophthalmic solutions.
• In May 2025, University of Waterloo announced a study to evaluate changes in comfort and dryness in symptomatic contact lens (CL) wearers after using Xiidra (lifitegrast 5.0% ophthalmic solution) for 12 weeks.
• In the assessment done by DelveInsight, the estimated total diagnosed prevalent cases of Dry eye disease in the 7MM were nearly 54,695 thousand in 2023.
• Among the European countries, the United Kingdom had the highest diagnosed prevalent cases of Dry eye disease with ~6,112 thousand cases, followed by Germany, which had diagnosed prevalent population of ~5,004 thousand in 2023. On the other hand, Spain had the lowest prevalent population (2,064 thousand cases).
• In 2023, the Dry eye disease market size was highest in the US among the 7MM, accounting for approximately USD 2,739 million which is further expected to increase by 2034.
• In February 2025, Cambium Bio announced that the FDA approved the protocol for the phase III clinical trials of elate ocular for treating moderate to severe dry eye disease.
• In December 2024, the FDA announced a nationwide recall of a single-use eye drop. Alcon Laboratories recalled one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101), following a customer complaint about fungal contamination in a vial. This recall only affects the specified lot of Systane Lubricant Ultra PF eye drops.
• In January 2024, Alcon, headquartered in Switzerland, announced the success of its dry eye disease medication AR-15512 in meeting primary endpoints in two Phase III trials, namely COMET-2 and COMET-3. With encouraging results from these trials, the company intends to submit a new drug application (NDA) for AR-15512 to the US Food and Drug Administration (FDA) by mid-2024, as outlined in a press release dated January 9th.
• In January 2024, Stuart Therapeutics, a biopharmaceutical firm based in the United States, has initiated a Phase III clinical study for their drug candidate vezocolmitide (ST-100) targeting patients with dry eye disease. This randomized, placebo-controlled trial seeks to assess the effectiveness and safety of a single dose of the ophthalmic solution compared to a placebo. The trial is set to enroll 320 participants.
• According to a study conducted by Farrand et. al, based on weighted estimates, 6.8% of the US adult population was projected to have diagnosed Dry Eye Disease
• One study found that 17% of 2,127 patients visiting a hospital in Japan were diagnosed with dry eyes, while 14.6% in a group of 2,520 older individuals reported symptoms of dry eyes
• Key Dry Eye Disease Companies: Palatin Technologies, Inc., Aldeyra Therapeutics, Inc., ReGenTree/RegeneRx Biopharmaceuticals, Inc., Mimetogen, Alcon/Aerie Pharmaceuticals, BRIM Biotechnology, Inc., Seikagaku Corporation, Mitotech, Senju Pharmaceutical, Sylentis, S.A./PharmaMar, Stuart Therapeutics, VivaVision Biotech, HanAll BioPharma Co., Ltd./Daewoong Pharmaceutical Co. Ltd., Redwood Pharma AB, AxeroVision, Inc., OKYO Pharma, AxeroVision, Inc., AxeroVision, Inc., Glaukos Corporation, Oculis, and others
• Key Dry Eye Disease Therapies: PL9643, NOV03, CyclASol, MC2-03, and others
• The Dry Eye Disease epidemiology based on gender analyzed that females are more affected by Dry Eye Disease than males

Dry Eye Disease Overview

Dry eye disease (DED), also known as dry eye syndrome or keratoconjunctivitis sicca, is a prevalent and multifactorial condition characterized by insufficient tear production or excessive tear evaporation, leading to ocular surface inflammation and damage. This condition results in symptoms such as dryness, irritation, redness, burning, a gritty sensation, and blurred vision, which can significantly impact the quality of life.

The underlying causes of Dry Eye Disease are varied and can include age-related decline in tear production, hormonal changes, autoimmune diseases (like Sjögren’s syndrome), prolonged screen use, environmental factors (such as wind or dry climates), and certain medications. Meibomian gland dysfunction, where the glands responsible for the oily layer of the tear film are obstructed, is also a common contributor.

Dry Eye Disease Diagnosis involves a comprehensive eye examination, including patient history, tear film assessment, and specific tests like Schirmer’s test, tear breakup time (TBUT), and ocular surface staining.

Management of Dry Eye Disease focuses on alleviating symptoms and addressing the underlying causes. Treatment options include artificial tears, anti-inflammatory medications (such as cyclosporine or lifitegrast), punctal plugs to reduce tear drainage, and lifestyle modifications like increasing humidity and taking regular breaks during screen use. Advanced therapies, including intense pulsed light (IPL) therapy and autologous serum eye drops, may be considered for severe cases. Ongoing research aims to develop more effective treatments and improve understanding of this complex disease.

Get a Free sample for the Dry Eye Disease Market Report – Dry Eye Disease Treatment Market

Dry Eye Disease Market Outlook

The Dry Eye Disease market is expected to expand with the potential launch of novel therapies like RGN-259, Tavilermide (MIM-D3), and AR-15512, which could reshape treatment dynamics despite uncertain success rates.

In 2023, the US dominated the market with ~73% share of the 7MM, while the UK led in Europe (USD 232M) and Spain had the lowest share (~USD 80M). Overall, innovation and new approvals are anticipated to drive significant growth in the coming years.

The dynamics of the Dry Eye Disease market are anticipated to change in the coming years owing to the expected launch of emerging therapies and others during the forecasted period 2020-2034.

“Of the emerging therapies, MC2-03 (mc2 therapeutics), PL9643 (Palatin Technologies), and many other compelling treatments are expected to change the market scenario of Dry Eye Disease in the upcoming years.”

Dry Eye Disease (DED), or keratoconjunctivitis sicca, represents a growing market opportunity due to its high prevalence and need for better management solutions. Current treatments include artificial tears, prescription drugs (CEQUA, EYSUVIS), advanced therapies (LipiFlow), supplements, and specialized interventions for severe cases.

Dry Eye Disease Epidemiology

In 2023, Dry Eye Disease (DED) diagnosed prevalence in the 7MM was ~54.7 million cases. The US accounted for the highest share (41%), followed by the UK (~6.1M) and Germany (~5M), while Spain had the lowest (~2M). Japan reported the fewest cases overall (19%) among the 7MM.

In the US, prevalence was higher in females (~13M) compared to males (~9.4M), a gap expected to widen by 2034. Mild cases dominated (~11.2M), followed by severe (~4.5M), a trend projected to persist.

By age, the UK reported the highest burden in those 50+ years (~4.9M cases), with lower prevalence in younger groups. This demographic trend is also anticipated to continue through 2034.

Dry Eye Disease Epidemiology Segmentation:

The Dry Eye Disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Prevalence of Dry Eye Disease
• Prevalent Cases of Dry Eye Disease by severity
• Gender-specific Prevalence of Dry Eye Disease
• Diagnosed Cases of Episodic and Chronic Dry Eye Disease

Download the report to understand which factors are driving Dry Eye Disease epidemiology trends @ Dry Eye Disease Patient Pool Forecasting

Dry Eye Disease Market Drivers

• High Prevalence & Growing Patient Pool – Increasing cases across aging populations and rising diagnosis rates.
• Lifestyle & Environmental Factors – Increased screen time, contact lens usage, pollution, and aging drive higher incidence.
• Unmet Medical Needs – Limited long-term efficacy of OTC/artificial tears fuels demand for advanced therapies.
• Technological Advancements – Devices like LipiFlow and novel drug delivery systems improving treatment outcomes.
• Pipeline Innovation – Emerging therapies (RGN-259, Tavilermide, AR-15512, etc.) expected to transform the treatment landscape.
• Rising Awareness & Diagnosis – More ophthalmologists and optometrists screening for DED, boosting treatment uptake.

Dry Eye Disease Market Barriers

• Limited Efficacy of Current Therapies – Existing drugs often provide symptomatic relief but not a cure.
• High Treatment Costs – Advanced devices and branded prescription therapies can be expensive.
• Poor Patient Compliance – Frequent dosing and long-term management reduce adherence rates.
• Underdiagnosis & Misdiagnosis – Many patients mistake symptoms for allergies or aging, delaying proper treatment.
• Generic & OTC Competition – Widespread use of low-cost artificial tears limits adoption of premium therapies.
• Regulatory & Clinical Challenges – Variability in trial endpoints and high failure rates in late-stage pipelines.

Dry Eye Disease Drugs Uptake and Pipeline Development Activities

• Reproxalap (Aldeyra Therapeutics/AbbVie)

A first-in-class small-molecule modulator of RASP showing positive late-phase trial results in >2,400 patients with a strong safety profile. AbbVie holds exclusive option rights (Oct 2023).

• Tivanisiran (SYL1001, Sylentis/PharmaMar)

An siRNA eye drop targeting TRPV1 to regulate ocular pain and inflammation. Successfully met primary endpoint in the Phase III FYDES trial (Dec 2023).

• Tavilermide (MIM-D3, Mimetogen)

A cyclic peptidomimetic and TrkA receptor agonist mimicking NGF, promoting ocular lubrication. Demonstrated consistent efficacy in Phase II/III trials and is under Phase III evaluation.

• AR-15512 (Alcon/Aerie Pharmaceuticals)

A TRPM8 agonist activating cold-sensing receptors to relieve symptoms. Phase III COMET-2 and COMET-3 trials met primary endpoints; FDA NDA filing expected mid-2024.

• RP101 (Redwood Pharma)

A hormonal therapy for postmenopausal women with moderate-to-severe DED, restoring local estrogen to improve tear film. Despite positive Phase II outcomes, Redwood faces financial challenges and plans to sell the asset via auction.

To know more about Dry Eye Disease treatment, visit @ Dry Eye Disease Medication and Companies

Dry Eye Disease Companies

• Palatin Technologies, Inc.
• Aldeyra Therapeutics, Inc.
• ReGenTree / RegeneRx Biopharmaceuticals, Inc.
• Mimetogen
• Alcon / Aerie Pharmaceuticals
• BRIM Biotechnology, Inc.
• Seikagaku Corporation
• Mitotech
• Senju Pharmaceutical
• Sylentis, S.A. / PharmaMar
• Stuart Therapeutics
• VivaVision Biotech
• HanAll BioPharma Co., Ltd. / Daewoong Pharmaceutical Co., Ltd.
• Redwood Pharma AB
• AxeroVision, Inc.
• OKYO Pharma
• Glaukos Corporation
• Oculis
• Others

Scope of the Dry Eye Disease Market Report

• Study Period: 2020–2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Dry Eye Disease Companies: Palatin Technologies, Inc. (NYSEAMERICAN: PTN), Aldeyra Therapeutics, Inc. (NASDAQ: ALDX), RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX), Alcon Inc. (SIX: ALC), Aerie Pharmaceuticals (acquired by Alcon, formerly NASDAQ: AERI), BRIM Biotechnology, Inc. (TPEx: 6885), Seikagaku Corporation (TSE: 4548), Mitotech S.A. (private), Senju Pharmaceutical Co., Ltd. (private), Sylentis, S.A. (subsidiary of PharmaMar, BME: PHM), Stuart Therapeutics (private), VivaVision Biotech (N/A, private), HanAll BioPharma Co., Ltd. (KRX: 009420) / Daewoong Pharmaceutical Co. Ltd. (KRX: 069620), Redwood Pharma AB (NASDAQ First North: REDW), AxeroVision, Inc. (private), OKYO Pharma Ltd. (NASDAQ: OKYO), Glaukos Corporation (NYSE: GKOS), Oculis Holding AG (NASDAQ: OCS), others.
• Key Dry Eye Disease Therapies: PL9643, NOV03, CyclASol, MC2-03, and others
• Dry Eye Disease Therapeutic Assessment: Dry Eye Disease current marketed and Dry Eye Disease emerging therapies
• Dry Eye Disease Market Dynamics: Dry Eye Disease market drivers and Dry Eye Disease market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
• Dry Eye Disease Unmet Needs, KOL’s views, Analyst’s views, Dry Eye Disease Market Access and Reimbursement

Do you know how market launch of emerging therapies will be impacting the Dry Eye Disease market CAGR? Download sample report @ Dry Eye Disease clinical trials and fda approvals

Table of Contents

1. Dry Eye Disease Market Report Introduction

2. Executive Summary for Dry Eye Disease

3. SWOT analysis of Dry Eye Disease

4. Dry Eye Disease Patient Share (%) Overview at a Glance

5. Dry Eye Disease Market Overview at a Glance

6. Dry Eye Disease Disease Background and Overview

7. Dry Eye Disease Epidemiology and Patient Population

8. Country-Specific Patient Population of Dry Eye Disease

9. Dry Eye Disease Current Treatment and Medical Practices

10. Dry Eye Disease Unmet Needs

11. Dry Eye Disease Emerging Therapies

12. Dry Eye Disease Market Outlook

13. Country-Wise Dry Eye Disease Market Analysis (2020–2034)

14. Dry Eye Disease Market Access and Reimbursement of Therapies

15. Dry Eye Disease Market Drivers

16. Dry Eye Disease Market Barriers

17. Dry Eye Disease Appendix

18. Dry Eye Disease Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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