DelveInsight’s “Dry Eye Disease Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of the DED, historical and forecasted epidemiology as well as the DED market trends in the United States, EU4 and the UK (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

Discover which therapies are expected to grab the Dry Eye Syndrome Market Share @ Dry Eye Syndrome Market Outlook

Key Takeaways from the Dry Eye Syndrome 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).
• The US reported the highest number of total diagnosed prevalent cases of Dry eye disease among the 7MM countries with 41% whereas Japan reported the least cases (19%). This trend is anticipated to be followed during the forecast period as well.
• In the US, gender-specific diagnosed prevalent cases of DED revealed ~9,439 thousand cases among males and approximately ~13,035 thousand cases among females. Projections indicate that by 2034, the prevalence among females will surpass that of males.
• Severity-specific data from 2023 reported that mild DED affects the largest group in the US, with approximately 11,237 thousand cases, while severe cases totaled 4,495 thousand. It is projected that this trend, with a higher prevalence of mild cases compared to severe ones, will continue throughout the forecast period.
• DelveInsight’s analysis shows that the UK reported the highest number of DED cases in individuals aged 50 and older, with ~4,889 thousand cases. This was followed by ~691 thousand cases in the 40─49 age group and ~532 thousand cases in the 18─39 age group. Projections indicate that the UK is expected to continue leading in these figures by 2034.
• The leading Dry Eye Disease Companies such as 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 and others.
• Promising Dry Eye Disease Pipeline Therapies such as PL9643, NOV03, CyclASol, MC2-03, and others.

Stay ahead in the Dry Eye Syndrome Therapeutics Market with DelveInsight’s Strategic Report @ Dry Eye Syndrome Treatment Market

Dry Eye Syndrome Epidemiology Segmentation in the 7MM

• 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 Syndrome Epidemiology trends @ Dry Eye Syndrome Prevalence

Dry Eye Disease Marketed Drugs

• CEQUA (cyclosporine ophthalmic solution) 0.09%: Sun Pharma

CEQUA (cyclosporine ophthalmic solution) 0.09% is a clear, sterile solution used to enhance tear production in patients with dry eye disease (keratoconjunctivitis sicca). The recommended dosage is one drop in each eye twice daily, with the vial discarded after use. Cyclosporine, a calcineurin inhibitor, functions as a partial immunomodulator, though its precise mechanism in this topical form remains undefined. Approved by the US FDA in August 2018, CEQUA represents a targeted approach to managing tear production issues associated with ocular inflammation.

• TYRVAYA (varenicline solution): Oyster Point Pharma

Varenicline, a nicotinic acetylcholine receptor agonist, received US FDA approval in October 2021 for its use as TYRVAYA, a preservative-free nasal spray designed to treat DED. This new formulation offers an innovative method for managing the symptoms associated with dry eye disease. Administered as one spray in each nostril twice daily, TYRVAYA requires priming with seven actuations before the first use and re-priming with one actuation if not used for over five days. The efficacy of TYRVAYA is attributed to varenicline’s interaction with specific nicotinic acetylcholine receptor subtypes, which activates the trigeminal parasympathetic pathway, enhancing basal tear production. While varenicline’s binding to various neuronal nicotinic receptors is well-documented, the precise mechanism of action remains under investigation.

Dry Eye Disease Emerging Drugs

• Reproxalap: Aldeyra Therapeutics, Inc.

Reproxalap is an investigational new drug candidate in development for the treatment of dry eye disease and allergic conjunctivitis. Reproxalap is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which is elevated in ocular and systemic inflammatory disease. The mechanism of action of reproxalap has been supported by the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap has been studied in more than 2,400 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.

• Tivanisiran (SYL1001): Sylentis, S.A./PharmaMar

Tivanisiran (SYL1001) is a small interfering RNA (siRNA) that is administered in solution as eye drops. This siRNA inhibits the synthesis of transient receptor potential vanilloid-1, also known as TRPV1. TRPV1 is directly involved in the pathophysiology of dry eye disease as it has a dual function on the ocular surface. It acts in the detection, transmission, and regulation of the sensation of pain in the eye, as well as in the mediation of innate inflammatory response, mechanisms whose regulation is key for the treatment and prevention of DED. In December 2023, Sylentis, a PharmaMar Group company, reported that the FYDES (Phase III) study evaluating the safety of tivanisiran in patients with dry eye disease successfully met its primary endpoint.

• Tavilermide (MIM-D3): Mimetogen

Tavilermide is a cyclic peptidomimetic drug that mimics nerve growth factor (NGF) and acts as a partial TrkA receptor agonist, enhancing NGF’s effects crucial for ocular surface health. Unlike other dry eye therapies, it addresses multiple mechanisms of dry eye disease by promoting protein secretion from conjunctival glands, maintaining ocular lubrication. Tavilermide, a preservative-free sterile ophthalmic solution, has shown consistent safety and efficacy in Phase II and III trials and is currently under Phase III evaluation.

• AR-15512: Alcon/Aerie Pharmaceuticals

AR-15512, a novel topical agonist targeting the transient receptor potential melastatin 8 (TRPM8), is a pioneering treatment for dry eye disease symptoms. Scheduled for a New Drug Application filing with the FDA by mid-2024, AR-15512 works by activating TRPM8, a cold-sensing receptor found in the cornea and eyelid, which may alleviate dry eye symptoms. The drug is currently undergoing Phase III clinical trials.

• RP101: Redwood Pharma AB

RP101, a novel topical treatment for postmenopausal women with chronic, moderate-to-severe DED, represents a significant advancement as a hormonal therapy. The formulation aims to restore local estrogen levels in the eye, enhancing tear film production and addressing specific biological mechanisms underlying DED. With a convenient dosing regimen of one or two applications per day, RP101 has shown robust safety and efficacy in a European Phase II trial, reinforcing positive outcomes observed in previous US Phase II studies.

To learn more about Dry Eye Syndrome Treatment guidelines, visit @ Dry Eye Syndrome Clinical Trials Assessment

Dry Eye Syndrome 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 and others.

Dry eye disease Market Outlook

Dry eye disease, or keratoconjunctivitis sicca, represents a significant market opportunity due to its widespread impact and diverse treatment landscape. The market is driven by the need for effective management solutions addressing tear film imbalance, which causes discomfort and potential complications.

Dry Eye Disease Treatment Market

Current Dry eye disease treatment options include over-the-counter artificial tears and prescription medications like CEQUA and EYSUVIS. Advanced therapies, such as LipiFlow, are used to enhance tear quality, while lifestyle modifications and supplements like omega-3 fatty acids also play a role. Severe cases may require specialized interventions like punctal plugs or scleral contact lenses. With a growing focus on advanced treatment options, the market for DED is expanding, highlighting opportunities for innovation and investment in new therapies and technologies.

Learn more about the FDA-approved drugs for Dry Eye Syndrome @ Drugs for Dry Eye Syndrome Treatment

Scope of the Dry Eye Syndrome Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• Dry Eye Syndrome 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 and others.
• Dry Eye Disease Pipeline Therapies- PL9643, NOV03, CyclASol, MC2-03, and others.
• Dry Eye Syndrome Market Dynamics: Dry Eye Syndrome Market Drivers and Barriers
• Dry Eye Syndrome Market Access and Reimbursement, Unmet Needs and Future Perspectives

Table of Contents

1. Key Insights

2. Dry Eye Syndrome Market Report Introduction

3. Dry Eye Disease (DED) Market Overview at a Glance

4. Epidemiology and Market Methodology of DED

5. Executive Summary of Dry Eye Disease (DED)

6. Key Events

7. Dry Eye Syndrome Market Disease Background and Overview

8. Epidemiology and Patient Population

9. Patient Journey

10. Marketed Therapies

11. Emerging Therapies

12. DED: Market Analysis

13. Key Opinion Leaders’ Views

14. SWOT Analysis

15. Unmet Needs

16. Market Access and Reimbursement

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

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