Xiidra (lifitegrast) / Bausch Health - LARVOL DELTA

Evaluating the Safety and Efficacy of Lifitegrast in Cataract Patients with Dry Eye (ChiCTR) - P=N/A | N=80 | Not yet recruiting | Sponsor: DaZhou Dachuan District People's Hospital China（DaZhou Tihird People's Hospital）; DaZhou Dachuan District People's Hospital China（DaZhou Tihird Peop

New trial • Cataract • Dry Eye Disease • Ophthalmology

Selecting Vehicle Comparators in Dry Eye Disease Clinical Trials: Implications for Efficacy and Safety Assessment and Regulatory Outcomes. (PubMed, Ophthalmol Ther) - P1/2 | "This study found no evidence of superiority of lifitegrast 5% to a vehicle containing cyclodextrin. Use of a saline-based vehicle as the control in registration studies sets a low bar for approval and makes it challenging to judge whether a drug provides benefits beyond current artificial tears. To provide evidence of added therapeutic benefit, comparators that are not treatments for DED should include palliative excipient(s) similar to those found in artificial tears."

Journal • Dry Eye Disease • Ophthalmology

Risk of Incident Dry Eye Disease Among Patients with Chronic Pain Conditions. (PubMed, Am J Ophthalmol) - "CPCs are strongly associated with an increased risk of incident and prescription-requiring DED. These findings support consideration of CPCs as risk factors in the evaluation and management of DED and suggest that a subset of patients with DED may reflect broader pain-processing abnormalities."

Journal • Cataract • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Sjogren's Syndrome

Identification of ITGB2, ELN, and KLRK1 as stress granule-related biomarkers of pterygium through integrated transcriptomic analysis and machine learning. (PubMed, Biochem Biophys Res Commun) - "ITGB2, ELN, and KLRK1 were identified as potential SG-related biomarkers of pterygium and may participate in the CAMs pathway under the regulation of MTF1, PAX5, and BHLHE40."

Biomarker • Journal • Ophthalmology • ITGB2 • KLRK1 • MELTF • NKG2D • PAX5

A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease (clinicaltrials.gov) - P2 | N=443 | Completed | Sponsor: Bausch & Lomb Incorporated | Recruiting ➔ Completed | Trial completion date: Nov 2026 ➔ May 2026 | Trial primary completion date: Nov 2026 ➔ May 2026

Trial completion • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

Phosphosulindac (OXT-328) restores the suppressed corneal sensitivity in rabbits with dry eye disease: therapeutic implications. (PubMed, Front Drug Deliv) - "None of 7 compounds structurally related to PS affected CS nor did cyclosporine, lifitegrast and artificial tears...Two non-steroidal anti-inflammatory drugs (NSAIDs), ketorolac and bromfenac, and lidocaine suppressed CS in normal but not in dry eyes...This effect appears unique to PS, distinct from all tested compounds including the two currently approved drugs for DED. PS, in addition to affecting CS of DED, may improve its symptoms and merits further evaluation for the treatment of DED."

Journal • Preclinical • Anesthesia • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Disproportionality analysis of drug-associated tinnitus safety signals: a 43-year pharmacovigilance study. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "The strongest signal was diphenhydramine citrate/ibuprofen (ROR 10.71), followed by chloroquine phosphate (9.28)...This 43-year analysis identifies 74 positive drug-associated tinnitus signals, including novel immunobiologic (guselkumab, lifitegrast) and cardiovascular (lovastatin, terazosin) associations without current audiological labelling warnings. The delayed onset profile implicates cumulative cochlear injury mechanisms. These findings provide an actionable basis for regulatory prioritisation and prospective audiological safety research for drug classes where audiological monitoring protocols are currently absent."

Adverse events • Journal • Cardiovascular • Otorhinolaryngology • ROR1

Lifitegrast-eluting contact lens for dry eye disease: sustained release, enhanced ocular bioavailability, and robust in vitro-in vivo correlation. (PubMed, Drug Deliv Transl Res) - "These findings demonstrate that DeCLs represent a promising therapeutic approach for DED, providing sustained drug delivery, reduced side effects, and improved patient compliance. Furthermore, the novel in vitro release model developed in this study, which establishes strong in vitro-in vivo correlation, paves the way for more ethical pharmaceutical research by potentially reducing reliance on animal testing."

Journal • Preclinical • Dry Eye Disease • Ophthalmology

Targeting the ICAM-1/LFA-1 adhesion axis attenuates lethal Crimean-Congo hemorrhagic fever virus infection. (PubMed, Cell Insight) - "Importantly, in a lethal murine model of CCHFV infection, the treatment with lifitegrast sodium improved survival rates and concurrently alleviated leukocyte infiltration and tissue damage. These findings delineate an ICAM-1-mediated mechanism of vascular activation and inflammation in CCHFV infection and highlight a promising anti-inflammatory-based strategy for treating CCHF."

Journal • Hematological Disorders • Infectious Disease • Inflammation • ICAM1

An Overview of Rheumatoid Arthritis-Associated Dry Eye Disease, Scleritis, and Peripheral Ulcerative Keratitis. (PubMed, J Clin Med) - "According to the literature, dry eye disease (DED) is the most frequent ocular manifestation of RA, and it is primarily managed with lubrication and topical anti-inflammatory therapies, including cyclosporine and lifitegrast...Conventional management includes systemic corticosteroids and steroid-sparing agents such as methotrexate (MTX), azathioprine (AZA), cyclophosphamide (CYC), and mycophenolate mofetil (MMF) in aggressive cases. Escalation to biologic disease-modifying antirheumatic drugs (bDMARDs), specifically tumor necrosis factor-alpha (TNF-α) inhibitors and rituximab (RTX), is supported for refractory scleritis and corneal melt, although evidence is largely observational. Among anti-TNF agents, monoclonal antibodies, such as infliximab and adalimumab, appear more effective than etanercept for ocular inflammation...Evidence for DED therapies includes randomized controlled trials (RCTs), whereas data for RA-associated scleritis and PUK are largely derived from..."

Journal • Review • Conjunctivitis • Dry Eye Disease • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Keratitis • Ocular Infections • Ocular Inflammation • Oncology • Ophthalmology • Rheumatoid Arthritis • Rheumatology • Scleritis • Sjogren's Syndrome • Vasculitis

Real-world characteristics of autoimmune patients with dry eye disease treated with lifitegrast: Insights from the AAO IRIS® Registry (ARVO 2026) - "Conclusions Autoimmune patients with DED initiating lifitegrast in routine practice exhibited high inflammatory burden and frequent ocular comorbidities. These findings support lifitegrast as a targeted therapy for autoimmune-related DED in real-world settings."

Clinical • Real-world • Real-world evidence • Cataract • Dry Eye Disease • Glaucoma • Ocular Inflammation • Ophthalmology

Physician perspectives on the clinical use of concomitant perfluorohexyloctane and lifitegrast in dry eye disease management: Results from a nationwide survey (ARVO 2026) - "Conclusions Findings from this real-world survey of ECPs highlight the utility of concomitant use of PFHO and LIF for the treatment of DED in a broad spectrum of patients with DED. Physicians reported a high level of satisfaction with the efficacy and tolerability of concomitant therapy."

Clinical • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Comparative Efficacy of Cyclosporine and Lifitegrast in Various Mouse Models of Dry Eye Disease (ARVO 2026) - "Conclusions Different induction methods lead to varying dry eye progression. Each model has limitations, highlighting the importance of matching models to drug mechanisms for accurate efficacy evaluation."

Preclinical • Dry Eye Disease • Ophthalmology

0322: Topical lifitegrast therapy for dry eye disease: a systematic review and meta-analysis (ARVO 2026) - "Overall, the limited benefits should be weighed against the increased risk of adverse events. Further non-industry-sponsored RCTs are needed to clarify the magnitude and clinical relevance of these effects."

Retrospective data • Review • Dry Eye Disease • Ophthalmology

Early Response to treatment with lifitegrast ophthalmic solution in patients with dry eye disease: a post hoc analysis of two randomized trials (ARVO 2026) - P3 | "The group with rapid and sustained EDS reductions by week 2 tended to have lower symptom scores than the other subgroups, suggesting that early treatment may be beneficial for maximal response. Further studies to corroborate these findings are warranted."

Clinical • Retrospective data • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Identification of Novel Biomarkers and Stress Granules Associated Immunoregulatory Network in Pterygium through Integrated Transcriptome Analysis and Machine Learning Approaches (ARVO 2026) - "Moreover, lifitegrast, peginterferon, and ribavirin showed excellent binding ability with biomarkers and may be effective drugs for PT treatment...All of there three featured genes in PT group were significantly expressed compared to control group in the qPCR test (all p< 0.05). Conclusions The study identified ITGB2, ELN, and KLRK1 as SGs-associated biomarkers for PT and initially revealed the roles of SGs played in the development of PT, offering potential therapeutic targets for patients with the condition."

Biomarker • Machine learning • Ocular Inflammation • Ophthalmology • ITGB2 • KLRK1 • MELTF • NKG2D • PAX5

A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment (clinicaltrials.gov) - P4 | N=378 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2026 ➔ Jul 2026 | Trial primary completion date: Apr 2026 ➔ Jul 2026

Biomarker • Enrollment closed • Trial completion date • Trial primary completion date • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Biological cleansing: Toward improving ocular surface surgical outcomes. (PubMed, Indian J Ophthalmol) - "Depending on the clinical presentation and inflammatory load status, biological cleansing using (i) lubricants; (ii) eyelid hygiene; (iii) ocular surface washes; (iv) topical or oral nutraceuticals; (v) nonpharmacological treatments, such as thermal pulsation therapy and intense light therapy; (vi) topical immunomodulators, such as cyclosporine, tacrolimus, steroids, and Lifitegrast; and (vii) lifestyle modifications, such as diet and probiotics, can be followed. We and others have shown a reduction in these inflammatory factors on the ocular surface using one or more of these strategies. Incorporating biological cleansing protocols into presurgical preparation is a vital step toward modulating ocular surface biology to improve postoperative outcomes for patients."

Journal • Review • Cataract • Dry Eye Disease • Fibrosis • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Pain • IFNG • IL17A • IL1B • IL6 • MMP9 • TGFB1 • TNFA

Lifitegrast Ophthalmic Solution 5.0% (KH732) for Dry Eye Disease: A randomized, Multicenter, Double-Masked, vehicle-controlled Phase 3 Trial. (PubMed, Ocul Surf) - "Lifitegrast (KH732) improved both signs and symptoms of DED and was generally well tolerated, with potentially greater benefit in patients with prominent inferior corneal staining."

Journal • P3 data • Dry Eye Disease • Ophthalmology

(IVCM): Clinical Evaluation of Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease Using In Vivo Confocal Microscopy (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: Toyos Clinic

New P4 trial • Dry Eye Disease • Ophthalmology

Application of Lifitegrast Ophthalmic Solution in the Treatment of Dry Eye (ChiCTR) - P=N/A | N=100 | Sponsor: The Affiliated Hospital of Xuzhou Medical University; The Affiliated Hospital of Xuzhou Medical University

New trial • Dry Eye Disease • Ophthalmology

Identification and Analysis of Remimazolam's Potential Therapeutic Mechanisms in Murine Sepsis-Associated Encephalopathy via Transcriptomic Analysis. (PubMed, J Inflamm Res) - "Among the twenty-one candidate drugs predicted to target these hub genes, AVELUMAB-CD274 and LIFITEGRAST-ICAM1 exhibited high binding affinity. This study reveals that ICAM1, Tlr2, Cd274, and SOCS3 are key molecular correlates of remimazolam treatment in a murine SAE model. Our transcriptomic analysis offers insights into the molecular basis of remimazolam's protective effects, highlighting these genes and pathways for future research."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Infectious Disease • Inflammation • Septic Shock • ICAM1 • IL6 • PD-L1 • SOCS3 • TLR2 • TNFA

Redefining Dry Eye Disease Management: Emerging Pharmacologic and Device-Based Therapies in the Era of Precision Care: A Narrative Review. (PubMed, Ophthalmol Ther) - "New pharmacotherapies include next-generation anti-inflammatory drugs such as lifitegrast and improved cyclosporine formulations, along with short-term corticosteroid suspensions for acute flares. Long-term management increasingly follows a chronic-disease model emphasizing maintenance therapy, environmental modifications, digital health tools for symptom tracking, and proactive patient education to enhance adherence. By integrating innovative treatments with individualized management strategies, clinicians are now better equipped to disrupt the cycle of inflammation and tear film instability, ultimately improving outcomes for patients with dry eye disease."

Journal • Review • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology • MMP9

This is a Single Center, Open-label Prospective Study to Evaluate the Effect of Xiidra® (Lifitegrast Ophthalmic Solution 5.0%) on Tear Film Biomarkers in Dry Eye (clinicaltrials.gov) - P4 | N=36 | Not yet recruiting | Sponsor: Pittsburgh Research Institute

Biomarker • New P4 trial • Dry Eye Disease • Ophthalmology

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications (clinicaltrials.gov) - P=N/A | N=75 | Recruiting | Sponsor: University of California, Los Angeles | Trial completion date: Jun 2024 ➔ Dec 2026 | Trial primary completion date: Jun 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Glaucoma • Ophthalmology