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“Dry Eye Disease Pipeline Insight, 2026″ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Dry Eye Disease Market.

The Dry Eye Disease Pipeline report provides a comprehensive evaluation of pipeline products, spanning from pre-clinical development to market availability, with a focus on commercial and clinical aspects. It includes a detailed overview of each drug, encompassing its mechanism of action, clinical studies, potential NDA approvals, and various product development activities. These activities involve technology, collaborations, mergers, acquisitions, funding, designations, and other pertinent details related to the products in the pipeline.

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Some of the key takeaways from the Dry Eye Disease Pipeline Report:

• Companies across the globe are diligently working toward developing novel Dry Eye Disease treatment therapies with a considerable amount of success over the years.

• Dry Eye Disease companies working in the treatment market are Laboratorios Sophia, Iolyx Therapeutics, Oculis Pharma, HanAll BioPharma Co., Ltd., Stuart Therapeutics, Cambium Bio Limited, Azura Ophthalmics, Quorum Innovations, Serentrix, IVIEW Therapeutics, Taejoon Pharmaceutical, Seinda Pharmaceutical, Invirsa, GL Pharm Tech Corporation, Dreamhawk Vision Biotech, Inc, Aramis Biosciences, Kowa Company, Alcon, HanAll Biopharma, Seikagaku Corporation, Novaliq GmbH, and others, are developing therapies for the Dry Eye Disease treatment

• Emerging Dry Eye Disease therapies in the different phases of clinical trials are- PRO-190, ILYX 002, OCS-02, Tanfanercept, Vezocolmitide, CAM-101, AZR-MD-001, Qi 401, SER-114, iVIEW 1001, TJO-083, SY-201, INV-102, GLH8NDE, SHJ 002, A197, K-161, AR-15512, HL036, SI-614, NOV03, CyclASol, and others are expected to have a significant impact on the Dry Eye Disease market in the coming years.

• In October 2026, Alcon reported findings from a randomized, double-masked clinical study involving 256 patients with moderate-to-severe dry eye symptoms. SYSTANE PRO PF demonstrated non-inferior efficacy compared with MIEBO in reducing symptoms after two weeks and one month, as measured by Ocular Surface Disease Index (OSDI) scores. These findings provide comparative clinical evidence for an existing over-the-counter (OTC) product rather than representing a new FDA approval or an investigational drug development milestone.

• In October 2026, Oculis announced that it had completed patient randomization in its registrational PREDICT-1 clinical trial, enrolling a total of 176 participants. Nearly two-thirds of the enrolled patients carried the TNFR1 genetic variant previously associated with an enhanced response to treatment in Phase II studies. The company expected to report topline results by the end of 2026.

• In September 2026, Aldeyra announced plans to file a Formal Dispute Resolution Request (FDRR) with the US FDA to challenge the Complete Response Letter (CRL) issued for reproxalap in March 2026. The company anticipated submitting the request and meeting with the FDA’s Office of New Drugs during the fourth quarter of 2026. This development represents a regulatory appeal concerning the NDA review rather than a new drug approval or clinical-trial milestone.

• In June 2026, Oculis initiated its registrational PREDICT-1 Phase IIb/III clinical trial by dosing the first patient. The study is evaluating licaminlimab, a topical anti-TNF-α therapy, in patients with dry eye disease using a genotype-guided precision medicine approach. It aims to determine whether individuals carrying a specific TNFR1 genetic variant experience improved responses to treatment.

• In May 2026, Bausch + Lomb concluded the Phase II study of its investigational combination of lifitegrast and perfluorohexyloctane for dry eye disease. While the treatment did not meet the primary endpoint at Day 29, it demonstrated better outcomes than lifitegrast alone at Day 15. Following these results, the company indicated plans to move the combination therapy forward into Phase III clinical trials.

• In March 2026, The US FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for reproxalap, an investigational reactive aldehyde species modulator being developed for dry eye disease. The agency determined that the available clinical data were insufficient to establish the treatment’s efficacy, while no concerns related to safety or manufacturing were identified. This decision marked a regulatory setback for the candidate.

• In June 2025, Aldeyra Therapeutics has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for reproxalap, an investigational treatment aimed at addressing the signs and symptoms of dry eye disease (DED).

• In May 2025, The U.S. Food and Drug Administration (FDA) has approved Grifols’ investigational new drug (IND) application to begin a Phase II clinical trial for GRF312 Ophthalmic Solution—an immunoglobulin (IG) eye drop being developed as a potential treatment for dry eye disease (DED). DED is a common inflammatory eye condition characterized by inadequate lubrication of the eye’s surface, which, in severe cases, can lead to lasting vision impairment.

• In April 2025, Zhaoke Ophthalmology announced the enrollment of the first patient in its Phase III clinical trial evaluating Cyclosporine (CsA) Ophthalmic Gel for the treatment of moderate to severe dry eye disease (DED).

• In April 2025, Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company focused on developing first-in-class therapies targeting the melanocortin receptor system, has announced updated responder analysis results from its pivotal Phase 3 MELODY-1 trial. This study assessed the safety and efficacy of PL9643 compared to placebo in treating dry eye disease (DED). The latest data further reinforce PL9643’s clinical potential, demonstrating statistically significant complete symptom resolution across multiple endpoints—an outcome not achieved by any currently approved DED treatments highlighting its promise in addressing a key unmet need.

• In January 2025, Stuart Therapeutics, Inc., a clinical-stage pharmaceutical company focused on developing innovative treatments for ophthalmic diseases, has announced the completion of the last patient’s last visit in its Phase III clinical trial evaluating ST-100 (vezocolmitide) as a potential therapy for Dry Eye Disease.

Dry Eye Disease Overview

A lack of tear film homeostasis is the cause of dry eye disease (DED), also referred to as dry eye syndrome (DES), keratoconjunctivitis sicca (KCS), and keratitis sicca. DED is a multifactorial illness of the ocular surface.

Explore the latest Dry Eye Disease pipeline insights 2026, including emerging therapies, clinical trials, and market opportunities. Stay ahead in Dry Eye Disease Clinical Trials

Emerging Dry Eye Disease Drugs Under Different Phases of Clinical Development Include:

• PRO-190: Laboratorios Sophia

• ILYX 002: Iolyx Therapeutics

• OCS-02: Oculis Pharma

• Tanfanercept: HanAll BioPharma Co., Ltd.

• Vezocolmitide: Stuart Therapeutics

• CAM-101: Cambium Bio Limited

• AZR-MD-001: Azura Ophthalmics

• Qi 401: Quorum Innovations

• SER-114: Serentrix

• iVIEW 1001: IVIEW Therapeutics

• TJO-083: Taejoon Pharmaceutical

• SY-201: Seinda Pharmaceutical

• INV-102: Invirsa

• GLH8NDE: GL Pharm Tech Corporation

• SHJ 002: Dreamhawk Vision Biotech, Inc

• A197: Aramis Biosciences

• K-161: Kowa Company

• AR-15512: Alcon

• HL036: HanAll Biopharma

• SI-614: Seikagaku Corporation

• NOV03: Novaliq GmbH

• CyclASol: Novaliq GmbH

Dry Eye Disease Route of Administration

Dry Eye Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

• Oral

• Intravenous

• Subcutaneous

• Parenteral

• Topical

Dry Eye Disease Molecule Type

Dry Eye Disease Products have been categorized under various Molecule types, such as

• Recombinant fusion proteins

• Small molecule

• Monoclonal antibody

• Peptide

• Polymer

• Gene therapy

Dry Eye Disease Pipeline Therapeutics Assessment

• Dry Eye Disease Assessment by Product Type

• Dry Eye Disease By Stage and Product Type

• Dry Eye Disease Assessment by Route of Administration

• Dry Eye Disease By Stage and Route of Administration

• Dry Eye Disease Assessment by Molecule Type

• Dry Eye Disease by Stage and Molecule Type

DelveInsight’s Dry Eye Disease Report covers around 50+ products under different phases of clinical development like

• Late-stage products (Phase III)

• Mid-stage products (Phase II)

• Early-stage product (Phase I)

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

• Route of Administration

Further Dry Eye Disease product details are provided in the report. Download the Dry Eye Disease pipeline report to learn more about the emerging Dry Eye Disease therapies

Some of the key companies in the Dry Eye Disease Therapeutics Market include:

Key companies developing therapies for Dry Eye Disease are – AbbVie Inc. (Allergan PLC), AFT Pharmaceuticals, Akorn, Alcon Inc., Bausch Health Companies Inc., Horus Pharma, Johnson & Johnson, Mitotech, Novaliq GmbH, OASIS Medical, Otsuka Pharmaceutical Co. Ltd, Prestige Consumer Healthcare, Santen Pharmaceutical Co. Ltd, Sentiss Pharma Pvt. Ltd, Sun Pharmaceutical Industries Ltd, VISUfarma, and others.

Dry Eye Disease Pipeline Analysis:

The Dry Eye Disease pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Dry Eye Disease with aggregate therapies developed by each company for the same.

• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Dry Eye Disease Treatment.

• Dry Eye Disease key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• Dry Eye Disease Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Dry Eye Disease market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Dry Eye Disease drugs and therapies

Dry Eye Disease Pipeline Market Drivers

• Increasing Disease Prevalence and Awareness: Rising recognition of psoriatic arthritis (PsA), particularly among individuals with psoriasis, is driving demand for effective treatment options and early diagnosis.

• Growing Adoption of Biologics: Increasing use of biologic therapies targeting TNF-α, IL-17, IL-23, and IL-12/23 pathways is supporting market growth through improved disease management.

• Advancements in Targeted Therapies: Development of novel oral therapies, selective TYK2 inhibitors, next-generation IL-17 inhibitors, and other targeted treatments is expanding therapeutic options.

• High Unmet Medical Needs: Inadequate response to existing treatments, persistent joint inflammation, disease progression, and difficulties achieving sustained remission are creating opportunities for innovative therapies.

• Increasing R&D Investments and Pipeline Activity: Pharmaceutical companies are investing in new mechanisms of action, combination approaches, and personalized treatment strategies to improve clinical outcomes.

Dry Eye Disease Pipeline Market Barriers

• High Treatment Costs: Expensive biologics and targeted therapies can restrict patient access, increase healthcare expenditure, and create reimbursement challenges.

• Intense Market Competition: The presence of established TNF inhibitors, IL-17 inhibitors, IL-23 inhibitors, and oral therapies makes it difficult for emerging treatments to achieve market differentiation.

• Safety and Tolerability Concerns: Potential adverse effects, infection risks, and class-specific safety considerations may limit the use of certain targeted therapies.

• Biosimilar and Generic Competition: Patent expirations and the entry of biosimilars and generics can increase pricing pressure and reduce the market share of branded therapies.

• Clinical Development Challenges: Variability in disease manifestations, treatment responses, and the need to demonstrate sustained improvements across joint, skin, and other disease symptoms can complicate clinical development.

Scope of Dry Eye Disease Pipeline Drug Insight

• Coverage: Global

• Key Dry Eye Disease Companies: Laboratorios Sophia, Iolyx Therapeutics, Oculis Pharma, HanAll BioPharma Co., Ltd., Stuart Therapeutics, Cambium Bio Limited, Azura Ophthalmics, Quorum Innovations, Serentrix, IVIEW Therapeutics, Taejoon Pharmaceutical, Seinda Pharmaceutical, Invirsa, GL Pharm Tech Corporation, Dreamhawk Vision Biotech, Inc, Aramis Biosciences, Kowa Company, Alcon, HanAll Biopharma, Seikagaku Corporation, Novaliq GmbH, and others

• Key Dry Eye Disease Therapies: PRO-190, ILYX 002, OCS-02, Tanfanercept, Vezocolmitide, CAM-101, AZR-MD-001, Qi 401, SER-114, iVIEW 1001, TJO-083, SY-201, INV-102, GLH8NDE, SHJ 002, A197, K-161, AR-15512, HL036, SI-614, NOV03, CyclASol, 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

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Table of Contents

1. Dry Eye Disease Report Introduction

2. Dry Eye Disease Executive Summary

3. Dry Eye Disease Overview

4. Dry Eye Disease- Analytical Perspective In-depth Commercial Assessment

5. Dry Eye Disease Pipeline Therapeutics

6. Dry Eye Disease Late Stage Products (Phase II/III)

7. Dry Eye Disease Mid Stage Products (Phase II)

8. Dry Eye Disease Early Stage Products (Phase I)

9. Dry Eye Disease Preclinical Stage Products

10. Dry Eye Disease Therapeutics Assessment

11. Dry Eye Disease Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Dry Eye Disease Key Companies

14. Dry Eye Disease Key Products

15. Dry Eye Disease Unmet Needs

16 . Dry Eye Disease Market Drivers and Barriers

17. Dry Eye Disease Future Perspectives and Conclusion

18. Dry Eye Disease Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading 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 business growth and overcome challenges with a practical approach.

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