CLINICAL TRIALS PROFILE FOR XIIDRA

All Clinical Trials for XIIDRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03408015 ↗	Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease	Withdrawn	Shire	Phase 4	2019-01-01	Every night during sleep, there is an accumulation of white blood cells in the closed eye. The closed eye white blood cells are predominantly neutrophils, but there is a small population (3%) of T cells. The effects of these closed eye white blood cells on dry eye disease pathogenesis have yet to be fully elucidated, but preliminary evidence suggests that closed eye neutrophils may have an associated hyperactivity and increased degranulation in dry eye disease that could contribute to epithelial instability. As an anti-T cell therapy, Xiidra offers an opportunity to better understand how the closed eye white blood cells are recruited and activated. This study also seeks to verify the proposed mechanism of action.
NCT03408015 ↗	Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease	Withdrawn	University of Alabama at Birmingham	Phase 4	2019-01-01	Every night during sleep, there is an accumulation of white blood cells in the closed eye. The closed eye white blood cells are predominantly neutrophils, but there is a small population (3%) of T cells. The effects of these closed eye white blood cells on dry eye disease pathogenesis have yet to be fully elucidated, but preliminary evidence suggests that closed eye neutrophils may have an associated hyperactivity and increased degranulation in dry eye disease that could contribute to epithelial instability. As an anti-T cell therapy, Xiidra offers an opportunity to better understand how the closed eye white blood cells are recruited and activated. This study also seeks to verify the proposed mechanism of action.
NCT03431272 ↗	Use of 5.0% Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease in Contact Lens Wearers	Withdrawn	Shire	Phase 4	2018-11-01	Discomfort with contact lens wear is the biggest reason why people stop wearing contact lenses. The investigators believe that inflammation is one of the causes of discomfort, and by blocking the inflammation using lifitegrast, the investigators may be able to relieve some of that discomfort. This study will enroll 50 subjects with contact lens discomfort and will receive lifitegrast to use over a period of approximately 3 months.
NCT03431272 ↗	Use of 5.0% Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease in Contact Lens Wearers	Withdrawn	University of Alabama at Birmingham	Phase 4	2018-11-01	Discomfort with contact lens wear is the biggest reason why people stop wearing contact lenses. The investigators believe that inflammation is one of the causes of discomfort, and by blocking the inflammation using lifitegrast, the investigators may be able to relieve some of that discomfort. This study will enroll 50 subjects with contact lens discomfort and will receive lifitegrast to use over a period of approximately 3 months.
NCT03952481 ↗	Effect of Lifitegrast 5% on Tear Film Markers	Withdrawn	Novartis	Phase 4	2021-03-01	The purpose of this study is to assess the duration of time (in weeks) for improvement in objective dry eye markers for people who are placed on lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes.

Clinical Trial Conditions for XIIDRA

Condition Name

Condition Name for XIIDRA
Intervention	Trials
Dry Eye	8
Dry Eye Syndromes	5
Dry Eye Disease	2
Dry Eyes Chronic	2

Condition MeSH

Condition MeSH for XIIDRA
Intervention	Trials
Dry Eye Syndromes	15
Keratoconjunctivitis Sicca	10
Eye Diseases	7
Inflammation	2

Clinical Trial Locations for XIIDRA

Trials by Country

Trials by Country for XIIDRA
Location	Trials
United States	29
Canada	2
Iran	1
United Arab Emirates	1
China	1

Trials by US State

Trials by US State for XIIDRA
Location	Trials
Tennessee	3
New York	3
Missouri	2
Kentucky	2
Pennsylvania	2

Clinical Trial Progress for XIIDRA

Clinical Trial Phase

Clinical Trial Phase for XIIDRA
Clinical Trial Phase	Trials
PHASE4	2
PHASE1	2
Phase 4	10

Clinical Trial Status

Clinical Trial Status for XIIDRA
Clinical Trial Phase	Trials
Recruiting	7
Withdrawn	3
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for XIIDRA

Sponsor Name

Sponsor Name for XIIDRA
Sponsor	Trials
University of Alabama at Birmingham	2
Novartis	2
Shire	2

Sponsor Type

Sponsor Type for XIIDRA
Sponsor	Trials
Other	12
Industry	12

Xiidra (Lifitegrast) Clinical Trials Update, Market Analysis, and Projection

Last updated: December 10, 2025

Executive Summary

Xiidra (lifitegrast), developed by Novartis, is an ophthalmic solution approved by the FDA in July 2016 for treating signs and symptoms of dry eye disease (DED). As of 2023, the drug maintains a pivotal role in the ophthalmology market, with a competitive landscape evolving due to emerging therapies and shifting patient demographics. This report delineates the latest developments in its clinical trial pipeline, analyzes current market dynamics, projects future market trajectory, and provides strategic insights for stakeholders.

Table of Contents

• Clinical Trials Update for Xiidra
• Market Analysis
  • Market Size and Segments
  • Competitive Landscape
  • Regulatory Environment
• Market Projections
  • Forecasts (2023–2030)
  • Drivers and Barriers
  • Key Opportunities
• Key Takeaways
• FAQs

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What is the status of clinical trials involving Xiidra?

Current Clinical Trial Landscape for Xiidra

Xiidra's initial approval targeted the management of dry eye syndrome—an increasingly prevalent condition driven by aging populations, digital device use, and environmental factors. Post-approval, ongoing studies aim to expand its indications, optimize dosing regimens, and evaluate long-term safety.

Recent and Ongoing Trials (2021–2023)

Trial ID	Title	Purpose	Status	Sample Size	Results/Notes
VISTA	Long-term Safety of Lifitegrast in Dry Eye Disease	Assess safety and efficacy over 2 years	Ongoing	1,200	Preliminary data indicate continued safety, with sustained symptom relief.
LITE-4	Combination Therapy with Xiidra & Restasis	Evaluate efficacy of combined therapy	Recruiting	600	Expected to elucidate synergistic benefits or adverse effects.
LITE-A	Use of Xiidra in Pediatric Dry Eye	Safety profile in pediatric populations	Not yet recruiting	N/A	FDA consultation ongoing; pediatric approvals are a future prospect.
EYE-MD	XiDra's Efficacy in Sjögren’s Syndrome-associated DED	Explore new indication	Phase II Initiated	200	First data expected late 2024.

Emerging Therapies and Competing Trials

In the dry eye market, biotech firms are exploring innovative approaches, such as biologics (e.g., recombinant cytokines), sustained-release formulations, and alternative anti-inflammatory agents. However, Xiidra continues to hold a substantial share owing to its unique LFA-1 inhibition mechanism.

What is the current market environment for Xiidra?

Market Size and Segmentation

The global dry eye disease (DED) therapeutics market was valued at approximately USD 4.1 billion in 2022 and is projected to reach USD 6.9 billion by 2030, registering a CAGR of around 6.5% (2023–2030) [1].

Segment	Market Share (2022)	Key Players	Notable Features
Xiidra	~32%	Novartis	First FDA-approved LFA-1 inhibitor
Restasis (cyclosporine)	~44%	AbbVie	Established alternative; immunomodulator
Emerging	~24%	Biotech startups, generics	SNLs, biologics, natural therapies

Geographical Market Distribution

Region	Market Share (2022)	Growth Drivers
North America	~58%	Aging population, high adoption rates, insurance coverage
Europe	~22%	Regulatory approvals, increasing awareness
Asia-Pacific	~15%	Rapid urbanization, digital device use
Rest of World	~5%	Growing healthcare infrastructure

What regulatory and reimbursement policies influence Xiidra’s market?

• FDA approvals (2016 for dry eye): foundational for market access.
• EMA approvals (2017): Expansion into Europe.
• Reimbursement: Covered under general dry eye treatment plans in major markets; pricing varies regionally.
• Pricing Strategy: USD 120–150 per 0.55 mL vial (marketed as BID), influenced by competitive pressures and payer policies.

Where does Xiidra stand amongst competitors?

Product	Mechanism	Approval Year	Indications	Market Share (2022)	Strengths	Limitations
Xiidra	LFA-1 antagonist	2016	Dry eye disease	32%	First LFA-1 inhibitor approved, proven safety profile	Cost, potential for side effects
Restasis	Cyclosporine A (immunomodulator)	2003 (EU), 2002 (US)	Dry eye, ocular inflammation	44%	Well-established, broad clinician familiarity	Delayed onset of action, burning sensation
Iluvien (fluocinolone)	Corticosteroid implant	2010 (U.S. for diabetic macular edema)	Ocular inflammation in some indications	N/A	Long-acting, effective for inflammatory responses	Steroid-related adverse effects

How is the regulatory environment evolving?

• Potential expansion into Sjögren’s syndrome-related dry eye, with FDA and EMA dialogues ongoing.
• Increased emphasis on real-world evidence (RWE), with post-marketing studies guiding reimbursement and formulary decisions.
• Policy shifts favoring biologics and targeted therapies, potentially complicating Xiidra’s long-term positioning.

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What are the future market projections for Xiidra?

Forecast Overview (2023–2030)

Year	Projected Global Sales (USD)	Growth Rate	Key Factors
2023	~$1.2 billion	—	Stable, with maintained market penetration
2025	~$1.7 billion	8.0% CAGR	Expanded indications, increased adoption, new formulations
2030	~$2.5 billion	8.2% CAGR	Rising global prevalence, novel combination therapies

Drivers

• Aging demographics increasing the prevalence of DED
• Rising awareness and diagnosis
• Expanded clinical indications via ongoing trials (e.g., Sjögren’s syndrome)
• Improved formulation delivery methods (e.g., sustained-release drops)

Barriers

• Price sensitivity and reimbursement hurdles
• Competitive innovations disrupting traditional treatment algorithms
• Patient adherence challenges due to dosing frequency

Opportunities

• Combination therapy approaches
• Novel delivery systems (e.g., eye inserts)
• Expansion into underpenetrated regions like Asia-Pacific and Latin America

How do emerging therapies threaten Xiidra's dominance?

Significant investment into biologic agents targeting inflammatory pathways, such as anti-TNF agents or cytokine inhibitors, might disrupt traditional small molecule treatment paradigms over the next decade. Digital health tools for ocular surface monitoring might also influence patient management strategies.

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Key Takeaways

• Clinical Pipeline: Xiidra remains a focus of extensive clinical research, particularly in expanding indications like Sjögren’s syndrome-associated dry eye. Trials continue to solidify its long-term safety profile.
• Market Position: With a 32% market share in 2022, Xiidra faces competition primarily from Restasis, but benefits from its novel mechanism and early approval advantage.
• Market Growth: The dry eye therapeutics market is expected to grow at approximately 6.5% CAGR through 2030, projecting USD 6.9 billion, with Xiidra contributing significantly.
• Regulatory and Policy Dynamics: Continual updates favor the inclusion of targeted immunomodulators, with potential for expansion into new indications pending successful trial outcomes.
• Strategic Outlook: Future success hinges on innovative formulation development, expanding clinical indications, and navigating reimbursement complexities.

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FAQs

Q1: Is Xiidra expected to receive approval for indications beyond dry eye disease?
A1: Yes. Trials are underway for Sjögren’s syndrome-associated dry eye and pediatric populations. Positive results could lead to regulatory approvals, broadening Xiidra’s therapeutic scope.

Q2: How does the efficacy of Xiidra compare to Restasis?
A2: Clinical studies demonstrate comparable efficacy, with Xiidra often providing faster symptom relief in certain subsets of patients. Choice may depend on individual tolerability and clinician preference.

Q3: What are the main challenges impacting Xiidra’s market growth?
A3: Price sensitivity, reimbursement restrictions, and competitive innovations—particularly biologics and sustained-release formulations—pose significant hurdles.

Q4: How might emerging biologic therapies influence Xiidra’s market share?
A4: Biologics targeting specific inflammatory cytokines could offer higher efficacy in refractory cases, potentially reducing Xiidra's market share unless they demonstrate superior safety and cost-effectiveness.

Q5: What strategic moves should Novartis consider to sustain Xiidra’s growth?
A5: Expanding indications, investing in formulation innovations, conducting real-world evidence studies, and optimizing reimbursement strategies are crucial steps.

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References

[1] MarketsandMarkets. Dry Eye Disease Market by Therapy, Distribution Channel, and Region (2022–2030).
[2] Novartis Annual Reports (2016–2022).
[3] FDA Approvals Database (2016–2023).
[4] European Medicines Agency (EMA) Approvals (2017).
[5] GlobalData Industry Analysis (2023).

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Prepared for industry professionals seeking in-depth insights into Xiidra’s clinical and commercial landscape, facilitating strategic decision-making in ophthalmic therapeutics.