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(Albany, US) On October 28, 2026, DelveInsight’s “Autoimmune Uveitis Market Insights, Epidemiology and Market Forecast – 2036” report provides comprehensive insights into the Autoimmune Uveitis market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type, and examines the market drivers and barriers shaping the space.

Discover the latest drugs and treatment options in the Autoimmune Uveitis Pipeline @ https://www.delveinsight.com/report-store/autoimmune-uveitis-market

Key Takeaways from the Autoimmune Uveitis Report

• The Autoimmune Uveitis therapeutics market was valued at about USD 1.2 billion in 2025 and is projected to grow at a CAGR of roughly 7% from 2026 to 2036. The US accounted for about USD 700 million of the 2025 market.

• In January 2026, Novaliq received US FDA IND clearance for NOV05 (topical tacrolimus eye drops) to start the Phase II EYETAC trial in non-infectious anterior uveitis, designed to provide localized immunosuppression while reducing systemic steroid exposure.

• In October 2025, Celltrion announced FDA approval of an expanded pediatric indication for adalimumab-aaty (YUFLYMA) for children aged 2 years and older with non-infectious uveitis.

• In September 2025, Priovant Therapeutics received FDA Fast Track Designation for brepocitinib in non-anterior non-infectious uveitis. Enrollment continues in the Phase III CLARITY trial, with results expected in the second half of 2026.

• In April 2025, VivaVision Biotech announced positive Phase II topline results for VVN461 in non-infectious anterior uveitis, showing non-inferior efficacy versus prednisolone acetate with favorable safety, and plans to advance to Phase III.

• DelveInsight’s report depicts a robust space, with a pipeline increasingly focused on targeted, steroid-sparing, and localized therapies for autoimmune uveitis.

• Leading Autoimmune Uveitis companies include AbbVie, Tarsier Pharma, Priovant Therapeutics, Chugai Pharmaceuticals, Harrow, Novaliq, VivaVision Biotech, and others.

• Promising therapies include adalimumab (HUMIRA), triamcinolone acetonide (TRIESENCE), TRS01 (dazdotuftide), brepocitinib, RAY121, OCS-02, VVN461, NOV05, and others.

Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Autoimmune Uveitis Treatment Drugs

Autoimmune Uveitis Overview

Autoimmune uveitis is an inflammatory process of the uveal tract caused by an autoimmune reaction to self-antigens or an innate inflammatory reaction secondary to an external stimulus. It can occur in isolation or alongside a systemic autoimmune or auto-inflammatory disease, and is categorized as infectious or noninfectious. It principally affects young people and can lead to significant visual limitation or blindness. Anterior uveitis is the most prevalent type, accounting for about 81% of uveitis patients, and roughly half of cases are recurring or chronic. Corticosteroid eye drops remain the first-line standard of care, while systemic immunomodulators and biologics are generally reserved for second or third line to reduce long-term steroid exposure. Adalimumab (HUMIRA) is the only FDA-approved systemic biologic for non-infectious intermediate, posterior, and panuveitis.

Common symptoms include:

• Ocular pain and redness

• Photophobia and lacrimation

• Blurred vision

• Floaters

• Headache

• Injected conjunctiva (children may be asymptomatic)

Autoimmune Uveitis Emerging Drugs Profile

TRS01 (Dazdotuftide): Tarsier Pharma TRS01 is a polypeptide conjugate with a dual mechanism of action: it induces anti-inflammatory macrophages and inhibits the NF-kB signaling pathway through toll-like receptor 4 (TLR4). Clinical findings point to efficacy at least comparable to corticosteroids with fewer side effects, giving it the potential to outperform corticosteroids in non-infectious uveitis. It is administered topically.

Brepocitinib: Priovant Therapeutics Brepocitinib is a once-daily oral dual TYK2/JAK1 inhibitor that suppresses pro-inflammatory cytokine signaling, including type I/II interferon, IL-6, IL-12, and IL-23 pathways. It is in late-stage development for several autoimmune diseases, with a Phase III study in non-infectious uveitis (NIU) reporting results in the second half of 2026. It holds FDA Fast Track Designation for non-anterior NIU. Currently, the drug is in Phase III.

RAY121: Chugai Pharmaceutical RAY121 is a subcutaneously administered monoclonal antibody that selectively inhibits the classical complement pathway by targeting complement C1s. It is being studied across several immune-mediated conditions. Currently, the drug is in Phase Ib.

VVN461: VivaVision Biotech VVN461 is an investigational therapy for non-infectious anterior uveitis. Phase II results showed non-inferior efficacy versus prednisolone acetate with favorable safety, and the company plans to advance it into Phase III.

NOV05: Novaliq NOV05 is a topical tacrolimus eye drop designed to provide localized immunosuppression while reducing systemic steroid exposure. It received FDA IND clearance in January 2026 to start the Phase II EYETAC trial in non-infectious anterior uveitis.

Explore groundbreaking therapies and clinical trials in the Autoimmune Uveitis Pipeline @ New Autoimmune Uveitis Treatment Drugs

Autoimmune Uveitis Market Drivers

• Growing patient pool and awareness: Diagnosed prevalent cases in the 7MM were nearly 673,000 in 2025, and greater awareness and better diagnostics are expanding the diagnosed population.

• Dominance of biologics: Biologics lead the landscape in moderate to severe disease, making up about USD 800 million of the 7MM market in 2025.

• Strong pipeline of targeted therapies: TYK2/JAK1 inhibitors, topical agents such as TRS01 and NOV05, and complement and TNF-targeting candidates aim to improve efficacy and reduce dosing frequency and systemic side effects.

• Demand for steroid-sparing options: Reliance on corticosteroids and their complications is driving demand for safer long-term alternatives.

• Regulatory support: Fast Track Designation, IND clearances, and expanded indications, such as the pediatric approval for YUFLYMA, are accelerating development and access.

• Innovation in localized delivery: Interest in topical biologics, gene therapies, and localized drug delivery is opening new treatment avenues.

Autoimmune Uveitis Market Barriers

• Reliance on long-term corticosteroids: Prolonged use brings cataracts, glaucoma, elevated intraocular pressure, and systemic adverse effects.

• Limited approved biologics: Adalimumab is the only approved systemic biologic for non-infectious intermediate, posterior, and panuveitis, and many immunomodulators are used off-label.

• Frequent recurrence and chronic relapse: About half of cases are recurring or chronic, and no curative therapy exists.

• Biosimilar competition: Adalimumab biosimilars may erode branded revenue even as they widen access.

• No universal diagnostic approach: Evaluation of uveitis varies, which can delay diagnosis and appropriate treatment.

• Rarity of the disease: A relatively small patient pool and heterogeneous subtypes complicate clinical trials and commercial planning.

• Competition from entrenched therapies: Established corticosteroids and immunomodulators set a high bar for new entrants to demonstrate differentiation.

Download DelveInsight’s in-depth Autoimmune Uveitis report today! @ Autoimmune Uveitis Companies

The Autoimmune Uveitis Report Provides Insights Into

• Companies developing and marketing Autoimmune Uveitis therapies, with aggregate therapies per company

• Candidates segmented into early-, mid-, and late-stage development

• Active and inactive (dormant or discontinued) projects

• Drugs by stage, route of administration, target, monotherapy vs. combination, mechanism of action, and molecule type

• Collaborations (company–company and company–academia), licensing agreements, and financing details

• Market drivers, barriers, and unmet needs

Autoimmune Uveitis Companies AbbVie, Tarsier Pharma, Priovant Therapeutics, Chugai Pharmaceutical, Harrow, Novaliq, VivaVision Biotech, and others.

Route of Administration: Oral, Topical, Subcutaneous, Intravitreal

Molecule Types: Small molecule, Monoclonal antibody, Polypeptide conjugate

Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Autoimmune Uveitis Market Drivers and Barriers

Scope of the Autoimmune Uveitis Report

• Coverage: 7MM (US, EU4, UK, Japan)

• Companies: As listed above

• Therapies: Adalimumab (HUMIRA), triamcinolone acetonide (TRIESENCE), TRS01 (dazdotuftide), brepocitinib, RAY121, VVN461, NOV05, and others

• Assessment by Product Type: Mono, Combination, Mono/Combination

• Assessment by Clinical Stage: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Table of Contents

1. Introduction

2. Executive Summary

3. Autoimmune Uveitis: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. DelveInsight’s Analytical Perspective

7. Late Stage Products (Phase III): Brepocitinib (Priovant Therapeutics), TRS01 (Tarsier Pharma)

8. Mid Stage Products (Phase II): VVN461 (VivaVision Biotech), NOV05 (Novaliq)

9. Early Stage Products (Phase I): RAY121 (Chugai Pharmaceutical)

10. Preclinical and Discovery Stage Products

11. Inactive Products

12. Key Companies

13. Key Products

14. Unmet Needs

15. Market Drivers and Barriers

16. Future Perspectives and Conclusion

17. Analyst Views

18. Appendix

19. About Us

About DelveInsight

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.

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