CLINICAL TRIALS PROFILE FOR LIFITEGRAST

All Clinical Trials for Lifitegrast

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00882687 ↗	Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis	Completed	Shire	Phase 2	2009-04-24	The purpose of this study is to determine whether SAR 1118 at three different concentrations, compared to placebo, is effective in the prevention of the signs and symptoms of allergic conjunctivitis
NCT00926185 ↗	A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE)	Completed	Shire	Phase 2	2009-08-03	The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.
NCT01421498 ↗	Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)	Completed	Shire	Phase 3	2011-08-29	The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.
NCT01636206 ↗	Safety Study of Lifitegrast to Treat Dry Eye	Completed	Shire	Phase 3	2012-10-16	The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.
NCT01743729 ↗	A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye	Completed	Shire	Phase 3	2012-12-07	The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye.
NCT02284516 ↗	A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)	Completed	Shire	Phase 3	2014-11-06	Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.
NCT03408015 ↗	Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease	Withdrawn	Shire	Phase 4	2019-01-01	Every night during sleep, there is an accumulation of white blood cells in the closed eye.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.

Clinical Trial Conditions for Lifitegrast

Condition Name

Condition Name for Lifitegrast
Intervention	Trials
Dry Eye	11
Dry Eye Disease	4
Dry Eye Syndromes	3
Keratoconjunctivitis Sicca	2

Condition MeSH

Condition MeSH for Lifitegrast
Intervention	Trials
Dry Eye Syndromes	17
Keratoconjunctivitis Sicca	16
Eye Diseases	10
Keratoconjunctivitis	2

Clinical Trial Locations for Lifitegrast

Trials by Country

Trials by Country for Lifitegrast
Location	Trials
United States	68
Canada	1
United Arab Emirates	1

Trials by US State

Trials by US State for Lifitegrast
Location	Trials
New York	5
Tennessee	5
Ohio	4
California	4
Kentucky	4

Clinical Trial Progress for Lifitegrast

Clinical Trial Phase

Clinical Trial Phase for Lifitegrast
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	4
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Lifitegrast
Clinical Trial Phase	Trials
Completed	8
Recruiting	5
Withdrawn	3

Clinical Trial Sponsors for Lifitegrast

Sponsor Name

Sponsor Name for Lifitegrast
Sponsor	Trials
Shire	8
Novartis	3
University of Alabama at Birmingham	2

Sponsor Type

Sponsor Type for Lifitegrast
Sponsor	Trials
Industry	16
Other	11

Lifitegrast: Clinical Trials, Market Analysis, and Projections

Introduction to Lifitegrast

Lifitegrast, marketed under the brand name Xiidra, is a lymphocyte function-associated antigen-1 (LFA-1) antagonist used for the treatment of the signs and symptoms of dry eye disease (DED). Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Key Clinical Trials

Several clinical trials have been conducted to evaluate the efficacy and safety of lifitegrast in patients with dry eye disease.

• OPUS-2 and OPUS-3 Trials: These were 12-week, prospective, double-masked, multicenter, placebo-controlled, randomized, parallel-arm clinical trials. The trials demonstrated that lifitegrast significantly reduced eye dryness and improved tear production. A post hoc analysis of these trials showed that lifitegrast-treated participants with moderate to severe DED had higher odds of achieving simultaneous improvement in clinical signs and symptoms compared to placebo-treated participants[1].

• Responder Analysis: The post hoc responder analysis from the OPUS-2 and OPUS-3 trials stratified participants into four subgroups based on the severity of inferior corneal staining score (ICSS) and eye dryness score (EDS) at baseline. The analysis revealed that lifitegrast-treated patients in the subgroup with ICSS greater than 1.5 and EDS of at least 60 at baseline had a 1.70- to 2.11-fold higher odds of achieving clinically meaningful improvement across all sign and symptom endpoints[1].

• Recent Clinical Study: A prospective randomized clinical trial involving 32 patients with ocular graft-versus-host disease (oGVHD) further supported the clinical evidence of lifitegrast. The study showed statistically significant reductions in mean Symptom Assessment iN Dry Eye (SANDE) score and unanesthetized Schirmer score at four weeks post-randomization[4].

Safety and Tolerability

Clinical trials have generally shown that lifitegrast is safe and well-tolerated. The primary safety endpoints, including intraocular pressure, visual acuity, and rate of treatment-related adverse effects, did not indicate significant concerns[4].

Market Analysis

Current Market Size and Growth

The dry eye disease market, which includes lifitegrast, is experiencing significant growth. As of 2023, the market size was estimated to be around USD 3.1 billion and is projected to reach USD 5.2 billion by 2034, exhibiting a compound annual growth rate (CAGR) of 4.8% during the forecast period[2].

Market Drivers

Several factors are driving the growth of the dry eye disease market:

• Innovative Therapeutic Developments: The introduction of novel drugs like lifitegrast and cyclosporine A has enhanced patient outcomes. These treatments target the inflammatory process and improve tear production, providing long-term benefits for chronic sufferers[2].

• Advanced Diagnostics: The use of artificial intelligence (AI) and machine learning in diagnostics is improving early detection and personalized treatment plans, further boosting the market[2].

• Increasing Screen Time and Aging Population: The rising prevalence of dry eye disease due to increased screen time and an aging population is also a significant driver[5].

Market Segmentation

The dry eye disease market is segmented by product type, with the artificial tears segment holding the largest market share. However, the anti-inflammatory drugs segment, which includes lifitegrast, is projected to witness the highest growth during the forecast period, with a CAGR of over 18%[5].

Projections and Future Outlook

Market Projections

The global dry eye disease market is anticipated to exhibit a CAGR of 16.4% during the forecast period from 2024 to 2031, reaching a value of USD 13.26 billion by 2031[5].

Regional Dominance

North America dominates the global dry eye disease market and is expected to retain its position throughout the forecast period, driven by a growing elderly population, increasing usage of digital devices, and the availability of advanced treatment options[5].

Competitive Landscape

The market for dry eye disease treatments is competitive, with key players including Bausch + Lomb, which recently acquired Xiidra (lifitegrast) from Novartis as part of a strategic move to focus on prioritized therapeutic areas. Other major players include Santen Pharmaceutical Co. Ltd, OASIS Medical, Alcon Inc., and AbbVie Inc. (Allergan PLC)[2][5].

Key Takeaways

• Clinical Efficacy: Lifitegrast has demonstrated significant efficacy in reducing eye dryness and improving tear production in patients with dry eye disease, particularly in those with moderate to severe symptoms.
• Market Growth: The dry eye disease market is expected to grow substantially, driven by innovative therapeutic developments, advanced diagnostics, and increasing prevalence due to screen time and an aging population.
• Market Segmentation: The anti-inflammatory drugs segment, which includes lifitegrast, is projected to witness high growth rates in the coming years.
• Regional Dominance: North America is expected to continue dominating the global market due to favorable demographic and technological factors.

FAQs

What is lifitegrast used for?

Lifitegrast is used for the treatment of the signs and symptoms of dry eye disease (DED).

How does lifitegrast work?

Lifitegrast works by inhibiting the inflammatory process that contributes to dry eye symptoms, specifically by antagonizing the lymphocyte function-associated antigen-1 (LFA-1)[3].

What were the key findings of the OPUS-2 and OPUS-3 trials?

The OPUS-2 and OPUS-3 trials demonstrated that lifitegrast significantly reduced eye dryness and improved tear production. A post hoc analysis showed higher odds of achieving simultaneous improvement in clinical signs and symptoms in patients with moderate to severe DED[1].

What is the projected market size for dry eye disease treatments by 2034?

The dry eye disease market is expected to reach USD 5.2 billion by 2034, exhibiting a CAGR of 4.8% during the forecast period[2].

Who are the key players in the dry eye disease market?

Key players include Bausch + Lomb, Santen Pharmaceutical Co. Ltd, OASIS Medical, Alcon Inc., and AbbVie Inc. (Allergan PLC)[2][5].

Sources

1. JAMA Ophthalmology: "Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients With Dry Eye Disease: A Post Hoc Analysis of 2 Randomized Clinical Trials"[1].
2. BioSpace: "Dry Eye Disease Market Size Estimated to Reach USD 5.2 Billion by 2034, Impelled by the Increased Popularity of Gene Therapy"[2].
3. DelveInsight: "Xiidra Drug Insight – Market Forecast – 2030"[3].
4. PubMed: "Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Patients With Ocular Graft-Versus-Host Disease: A Randomized Clinical Trial"[4].
5. Coherent Market Insights: "Dry Eye Disease Market Size to hit $13.26 Billion by 2031, Coherent Market Insights"[5].