Xiidra (lifitegrast) / Bausch Health - LARVOL DELTA

Pharmacovigilance Analysis of Lifitegrast-Associated Adverse Events Using the FDA Adverse Event Reporting System (FAERS) Database. (PubMed, Ocul Immunol Inflamm) - "Most lifitegrast-related AEs identified in this study were consistent with those described on the drug label, but some other signals potentially associated with lifitegrast were identified. Prospective studies are needed to verify and clarify these AEs' relationship to lifitegrast."

Adverse events • Journal • Dry Eye Disease • Infectious Disease • Musculoskeletal Diseases • Ophthalmology

Drug-Related Visual Blurring: Findings from the U.S. Food and Drug Administration Adverse Event Reporting System Database. (PubMed, Eur J Pharmacol) - "Preventing drug-related vision issues is vital. Early risk assessment and intervention with personalized medication can reduce side effects, ensure safety, and improve quality of life."

Adverse events • Journal • Oncology • Ophthalmology • Retinal Disorders

Utilising AI for the Identification and Validation of Novel Therapeutic Targets and Repurposed Drugs for Endometriosis (WCE 2025) - "Both subcutaneous and intraperitoneal administration of Lifitegrast, an approved ITGB2 antagonist, effectively suppresses lesion growth...Conclusion The study leveraged an AI target discovery platform to analyze transcriptomic datasets from patients with endometriosis and healthy controls. This innovative approach identified multiple novel targets and drug repurposing opportunities, underscoring AI's potential to accelerate the discovery of novel drug targets and facilitate the repurposing of treatment modalities for endometriosis."

Endometriosis • Gynecology • Women's Health • HCK • ITGB2

A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease (clinicaltrials.gov) - P1/2 | N=292 | Completed | Sponsor: AbbVie | Phase classification: P2 ➔ P1/2

Phase classification • Dry Eye Disease • Ophthalmology

Lifitegrast Sustains Rapid Effect for Dry Eye in Real-World Assessment (HCPLive) - "A quantitative and qualitative assessment of real-world utilization data reported the rapid and sustained response of lifitegrast ophthalmic solution 5% (Xiidra) for individuals with dry eye disease (DED)...Upon analysis, nearly all (92%) eyecare providers reported treating contact lens-induced DED with lifitegrast, with predominant uses including before or after refractive or cataract surgery (83% each). Approximately 67% of providers reported near or complete symptom resolution after 1 to 3 months of lifitegrast treatment...Further analysis found the average satisfaction ratings for onset and effectiveness of lifitegrast were 6.8 and 6.6, respectively. Sustained improvement was identified during treatment up to 12 months, which investigators confirmed was supported by case data (mean, 15 months). Safety analysis showed more than half (58%) of eyecare providers reported ≥1 patient experienced an adverse event during lifitegrast treatment." "

HEOR • Dry Eye Disease

Safety of lifitegrast: A real-world pharmacovigilance study based on FAERS. (PubMed, PLoS One) - "Among these signals, 71 AEs were documented in the product insert of Lifitegrast, including but not limited to eye irritation, eye pain and eye swelling. AEs not mentioned in the drug labeling were identified, such as glaucoma and cataracts.AEs associated with Lifitegrast are more commonly observed in male patients and those aged over 65 years.The insights derived from this FAERS database analysis are significant for optimizing the use of Lifitegrast while minimizing potential side effects, thereby enhancing the safety of its clinical application."

Adverse events • Journal • Real-world evidence • Retrospective data • Cataract • CNS Disorders • Dry Eye Disease • Glaucoma • Ophthalmology • Pain

Real-world experience with lifitegrast ophthalmic solution in patients with dry eye disease: a provider survey (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Real-world • Real-world evidence • Cataract • Dry Eye Disease • Ophthalmology

The Effect of Lifitegrast 5.0% Solution on Clinical Signs and Biomarkers in Dry Eye Disease: A Prospective, Multicenter Study (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Biomarker • Clinical • Dry Eye Disease • Ocular Inflammation • Ophthalmology • MMP9

Early adoption and utilization of perfluorohexyloctane ophthalmic solution for dry eye disease (ARVO 2025) - "CsA 0.05% (21.8%) and lifitegrast (17.1%) were most commonly used...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Dry Eye Disease • Ocular Inflammation • Ophthalmology

Early symptom relief with lifitegrast ophthalmic solution, 5.0% in patients with dry eye disease: a post-hoc analysis of two randomized clinical trials (ARVO 2025) - P3 | "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

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

The Mechanism of Action of Leucocyte Function-Associated Antigen (LFA-1) Antagonist Lifitegrast in Dry Eye Disease (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

IO biomarker • Dry Eye Disease • Ophthalmology • CCR4 • CD4 • CXCR3 • IFNG

Phase III Clinical Study of Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease (clinicaltrials.gov) - P3 | N=820 | Recruiting | Sponsor: Lunan Better Pharmaceutical Co., LTD.

New P3 trial • Dry Eye Disease • Ophthalmology

Drugs for dry eye disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dry Eye Disease • Ophthalmology

Therapeutic Potential of Combined 5% Lifitegrast and Tocopherol Eye Drops in Managing Inflammation and Oxidative Stress in Murine Dry Eye. (PubMed, Pharmaceuticals (Basel)) - " Female C57BL/6 were divided into seven groups: untreated controls, EDE control, EDE + 0.05% cyclosporin A (CsA), EDE + tocopherol (TCP), EDE + 5% LF, EDE + 5% LF + TCP (once daily), and EDE + 5% LF + TCP (twice daily). Combined 5% LF and TCP eye drops improved tear film parameters and reduced inflammatory and oxidative stress markers. The combination therapy can mitigate ocular surface damage by managing inflammation and oxidative stress in dry eye."

Journal • Preclinical • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology • CD4 • IFNG

Lifitegrast in Treatment of Dry Eye Disease-A Practical, Narrative Expert Review. (PubMed, J Ophthalmol) - " Based on the current literature, we conclude that lifitegrast could improve various parameters of DED. Still, larger controlled trials are required to establish additional benefits of this medication beyond those of other DED treatments."

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

Efficacy and Safety of 5% Lifitegrast Eye Drops in Treating Dry Eye: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial (ChiCTR) - P3 | N=960 | Completed | Sponsor: Xiamen eye center of Xiamen University; Qilu Pharmaceutical

New P3 trial • Dry Eye Disease • Ophthalmology

Real world pharmacovigilance assessment of drug related macular degeneration risks. (PubMed, Sci Rep) - "Among these, 42 drugs were linked to significant risks, including treatments for breast cancer (tamoxifen, raloxifene, anastrozole, letrozole) and diabetes (insulin lispro, insulin human). The BCPNN algorithm revealed that 45.2% (19/42) of these drugs had the strongest associations with macular degeneration, with pentosan polysulfate sodium, travoprost, and tolterodine being the highest-risk drugs. Lifitegrast, nicotine, and travoprost were associated with the shortest onset times for ocular adverse events...The incidence of drug-related macular degeneration has steadily increased in recent years. This study offers valuable pharmacovigilance insights, highlighting drugs and demographic factors linked to macular degeneration."

Adverse events • Journal • Real-world evidence • Age-related Macular Degeneration • Breast Cancer • Diabetes • Macular Degeneration • Metabolic Disorders • Oncology • Ophthalmology • Retinal Disorders • Solid Tumor

Comment on efficacy, safety, and tolerability of Lifitegrast 5% eye drops: A randomized, double-blind, active-controlled trial in Indian patients with dry eye disease. (PubMed, Indian J Ophthalmol) - No abstract available

Clinical • Journal • Dry Eye Disease • Ophthalmology

Lifitegrast, a Lymphocyte Function-Associated Antigen-1 Antagonist Demonstrates Beneficial Effect in Psoriasis. (PubMed, Drug Dev Res) - "In this work we explored the effect of lifitegrast in imiquimod induced psoriasis model in mice...This decrease in psoriasis inflammation was accompanied by decrease in TNF-α, IL-6, IL-22 and IL-17/IL-23 axis gene expression in the skin, and the effect is comparable to the oral cyclosporine A(5 mg/kg, twice a day) treatment. Lifitegrast demonstrated significant anti-inflammatory activity, mainly through reduction in cytokine gene expression related to psoriasis and decreased the severity of psoriasis in vivo. The significant effect shown by this LFA-1 and ICAM-1 antagonist indicates a novel topical treatment for psoriasis."

Journal • Dermatology • Dry Eye Disease • Immunology • Inflammation • Ophthalmology • Psoriasis • ICAM1 • IL17A • IL22 • IL23A • IL6 • TNFA

Utilizing AI for the Identification and Validation of Novel Therapeutic Targets and Repurposed Drugs for Endometriosis. (PubMed, Adv Sci (Weinh)) - "Collectively, these data present Lifitegrast as a previously unappreciated intervention for endometriosis treatment and identify GBP2 and HCK as novel druggable targets in endometriosis treatment. This study underscores AI's potential to accelerate the discovery of novel drug targets and facilitate the repurposing of treatment modalities for endometriosis."

Journal • Endometriosis • Gynecology • Women's Health • HCK • ITGB2

Effect of Citric Acid and Tromethamine on the Stability of Eyedrops Containing Lifitegrast. (PubMed, Pharmaceuticals (Basel)) - "Consequently, it was concluded that the developed lifitegrast-containing eyedrop formulation exhibited improved physicochemical stability, validated through statistical analyses. These findings contribute to the development of stable eyedrops and provide a foundation for commercial production and clinical applications."

Journal • Dry Eye Disease • Inflammation • Ophthalmology

Exploring and Validating the Mechanism of Ulinastatin in the Treatment of Sepsis-Associated Encephalopathy Based on Transcriptome Sequencing. (PubMed, J Inflamm Res) - "A total of 106 hub - gene - related drugs were predicted, among which BINDARIT - CCL2 and LIFITEGRAST - ICAM1 showed particularly high affinities. In conclusion, ICAM-1, IRF7, IL-1β, CCL2, IL-6, and SOCS3 were identified as potential therapeutic targets in SAE mice treated with UTI. This study offers theoretical support for UTI as a treatment option for SAE."

Journal • CNS Disorders • Infectious Disease • Septic Shock • CCL2 • ICAM1 • IL1B • IL6 • IRF7 • SOCS3

Efficacy and Safety of Topical Cyclosporine 0.05% and Lifitgrast on the Ocular Surface Symptom After Photorefractive Keratectomy in Feiz Hospital, Isfahan, 2024 (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Mohsen Pourazizi

New P1 trial • Inflammation • Ocular Inflammation • Pain

Comparison of Dry Eye Treatment Outcomes in Patients With or Without Autoimmune Disease (AAO 2024) - "Purpose To assess the efficacy of cyclosporine (CsA) and lifitegrast in patients with dry eye disease (DED) with or without autoimmune disease...Regression of change in PEE grades revealed that CsA is similarly associated with lower grades in autoimmune patients (CsA:autoim β = −0.52, P < .05). Conclusion Presence of autoimmune disease significantly modulates the efficacy of DED treatment."

Clinical • Cataract • Dry Eye Disease • Ophthalmology

Quintessence of currently approved and upcoming treatments for dry eye disease. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS® [cyclosporine 0.05% ophthalmic emulsion], VEVYE® [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA® (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED...Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS® and other approved treatments. The potential treatments being assessed include..."

Journal • Review • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • ICAM1