Xiidra (lifitegrast) / Bausch Health - LARVOL DELTA

Navigating the Dry Eye Therapeutic Puzzle: A Mechanism-Based Overview of Current Treatments. (PubMed, Pharmaceuticals (Basel)) - "Anti-inflammatory agents including cyclosporine, lifitegrast, and short-term corticosteroids improve ocular surface signs, with mixed symptom relief...Nerve-targeted therapies, including oral neuromodulators (gabapentin, antidepressants), botulinum toxin, and transcutaneous nerve stimulation, have shown potential for managing neuropathic ocular pain, although randomized data are limited... Personalized, mechanism-based treatment strategies are essential for optimizing outcomes in DED. Future research should prioritize well-designed, controlled studies to clarify the role of emerging therapies and guide the individualized management of this heterogeneous condition."

Journal • Review • Dry Eye Disease • Inflammation • Neuralgia • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain

A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment (clinicaltrials.gov) - P4 | N=350 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Recent Advances in Targeted Immunomodulatory Therapies for Chronic Ocular Surface Diseases. (PubMed, Semin Ophthalmol) - "In contrast, targeted immunomodulators such as cyclosporine, tacrolimus, lifitegrast, tofacitinib, and reproxalap provide more selective modulation of the immune response. While corticosteroids are indispensable for acute management, targeted immunomodulatory therapies offer a safer and more sustainable approach for long-term treatment of chronic ocular surface inflammation. The emergence of novel topical agents supports a shift toward precision immunotherapy in ophthalmology."

Journal • Review • Cataract • Conjunctivitis • Dry Eye Disease • Graft versus Host Disease • Immunology • Infectious Disease • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Real-World Experience with Lifitegrast Ophthalmic Solution in Patients with Dry Eye Disease: A Provider Survey in the USA and Canada. (PubMed, Ophthalmol Ther) - "This real-world survey showed that ECPs use lifitegrast to treat one fifth of their patients with DED and reported moderate-to-high personal and patient satisfaction with lifitegrast treatment."

Journal • Real-world evidence • Cataract • Dry Eye Disease • Ophthalmology • Pain

Lifitegrast Eye Drops in Healthy Subjects：Phase I Study (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1 trial • Dry Eye Disease • Ophthalmology

Topical lifitegrast therapy for dry eye disease. (PubMed, Cochrane Database Syst Rev) - "This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effectiveness and safety of topical lifitegrast therapy alone or in combination with artificial tears, compared with a placebo, artificial tears alone, or no treatment for dry eye disease."

Journal • Dry Eye Disease • Ophthalmology

A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment (clinicaltrials.gov) - P4 | N=350 | Not yet recruiting | Sponsor: Hoffmann-La Roche

Biomarker • New P4 trial • Dry Eye Disease • Ocular Inflammation • Ophthalmology

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