Vevye (cyclosporine ophthalmic solution) / Novaliq, Jiangsu Hengrui Pharma, Harrow Health, Thea Laboratories - LARVOL DELTA

Real-World Treatment Patterns and Clinical Outcomes with Cyclosporine 0.1% in Semifluorinated Alkane for Dry Eye Disease. (PubMed, Clin Ophthalmol) - "To evaluate real-world clinical outcomes and treatment patterns associated with long-term use of cyclosporine 0.1% in semifluorinated alkane (SFA) (VEVYE®, Harrow Inc, Nashville, TN, USA) in patients with dry eye disease (DED), focusing on patient-reported symptoms, and corneal staining. CsA/SFA was associated with clinically and statistically significant improvements in both patient-reported symptoms and corneal staining over six months, with concordant improvements in subjective and objective outcome measures. These findings support its use as an effective therapeutic option for moderate DED."

Clinical data • HEOR • Journal • Real-world evidence • Dry Eye Disease • Ophthalmology

Water-Free Cyclosporine 0.1% in Dry Eye Disease: Formulation Rationale, Clinical Evidence, and Unresolved Questions. (PubMed, Drug Des Devel Ther) - "Overall, water-free cyclosporine 0.1% represents a credible addition to anti-inflammatory therapy for moderate-to-severe DED, especially when rapid improvement in corneal staining and good drop tolerability are priorities. However, the evidence base remains largely vehicle-controlled and industry-linked, with limited head-to-head comparison against other immunomodulators."

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

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

Biomarker • Trial completion • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Hengrui Pharma Secures China Approval for Water-Free Cyclosporine Eye Drop for Dry Eye Disease (Eyewire News) - “Phase 3 data demonstrated significant improvements in corneal staining by Day 15 and Day 29, with a favorable safety and tolerability profile in patients with moderate-to-severe DED…The NMPA decision was supported by results from the multicenter, randomized, double-blind, vehicle-controlled Phase 3 SHR8028-301 trial conducted in China. The study enrolled 206 adults with moderate-to-severe dry eye disease, who were randomized 1:1 to receive either the investigational therapy or vehicle twice daily. Co-primary endpoints evaluated changes in total corneal fluorescein staining (tCFS) and eye dryness visual analog scale scores at Day 29.”

China approval • Dry Eye Disease

Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction (clinicaltrials.gov) - P4 | N=48 | Recruiting | Sponsor: University of Alabama at Birmingham | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology

CSAGCD: Comparison of Conjunctival Goblet Cell Density in Dry Eye Patients Treated With Cyclosporine 0.1% Dissolved in Perfluorobutylpentane (Vevye®) or Generic 0.05% Cyclosporine Emulsion for 8 Weeks (clinicaltrials.gov) - P4 | N=60 | Not yet recruiting | Sponsor: Baylor College of Medicine | Initiation date: Apr 2026 ➔ Sep 2026

Trial initiation date • Dry Eye Disease • Ophthalmology

LT10460-401: A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study (clinicaltrials.gov) - P4 | N=25 | Terminated | Sponsor: Medical University of Vienna | This record represents a duplicate entry and has therefore been withdrawn. The correct and complete study information can be found under identifier NCT07234318.

Trial completion date • Trial termination • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology

Pharmacokinetics and distribution of perfluorobutylpentane, a unique eye drop vehicle, in rabbits after topical administration (ARVO 2026) - "Purpose Perfluorobutylpentane is the vehicle of a cyclosporine, 0.1% solution which is approved in the US, Australia and New Zealand (Vevye™) as well as in Europe (Vevizye™)...Conclusions Following topical ocular administration in rabbits, the highest concentrations of perfluorobutylpentane were found in tears with a residence time of up to 8 hours, supporting a long-lasting reduction of friction. Perfluorobutylpentane exposure in systemic circulation and posterior ocular tissues was minimal, consistent with the demonstrated clinical safety profile."

PK/PD data • Preclinical • Ophthalmology

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

Real-World Assessment of VEVYE® for Short-Term Symptom and Sign Improvement of Dry Eye Disease in a Neuro-Ophthalmology Clinic: A 6-Month Prospective Observational Study (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Neuro-Ophthalmology of Texas

New trial • Real-world evidence • Dry Eye Disease • Ophthalmology

FLARE-VEV: Vevye + Flarex Combination Therapy for Dry Eye (clinicaltrials.gov) - P4 | N=60 | Enrolling by invitation | Sponsor: Canyon City Eyecare

New P4 trial • Dry Eye Disease • Ophthalmology

LT10460-401: A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study (clinicaltrials.gov) - P4 | N=25 | Recruiting | Sponsor: Medical University of Vienna

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

CSAGCD: Comparison of Conjunctival Goblet Cell Density in Dry Eye Patients Treated With Cyclosporine 0.1% Dissolved in Perfluorobutylpentane (Vevye®) or Generic 0.05% Cyclosporine Emulsion for 8 Weeks (clinicaltrials.gov) - P4 | N=60 | Not yet recruiting | Sponsor: Baylor College of Medicine

New P4 trial • Dry Eye Disease • Ophthalmology

Effect of increasing chain length on inhibition of evaporation by perfluoro compounds in an in vitro gravimetric assay (no word/character limit specified). (PubMed, Exp Eye Res) - "SFA chain length and volatility correlated with inhibition of the Revap of saline with the longest chain length SFAs F6H8 and F6H10 having the maximal effect. These data support the suitability of F6H8 as a treatment for evaporative dry eye disease."

Journal • Preclinical • Dry Eye Disease • Ophthalmology

Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction (clinicaltrials.gov) - P4 | N=48 | Not yet recruiting | Sponsor: University of Alabama at Birmingham

New P4 trial • Ophthalmology

A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine (clinicaltrials.gov) - P4 | N=204 | Completed | Sponsor: Novaliq GmbH | Active, not recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

Assessment the Safety of CyclASol compared with Vehicle and Commercially Available 0.05% Cyclosporine in Dry Eye Disease: A Systematic Review and Meta-analysis. (PubMed, Ophthalmol Ther) - "Based on the data presented in the meta-analysis, CyclASol is a safe treatment for patients with DED. However, the comparable likelihood of experiencing TEAEs and ocular TEAEs between CyclASol and 0.05% CsA suggests that there is not sufficient evidence to indicate a superior safety profile of CyclASol over commercially available CsA."

Journal • Retrospective data • 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 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

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

All eyes on semifluorinated alkanes: a comprehensive review of the influence of semifluorinated alkane eyedrops on tear film stabilization and drug delivery in dry eye disease. (PubMed, Expert Opin Drug Deliv) - "Clinical evidence demonstrates that PFBP-based CsA eyedrops (VEVYE®) have an earlier onset of action than aqueous CsA eyedrops and show a significant improvement in the clinical signs and symptoms of DED with high patient tolerability. Ongoing clinical trials are exploring the use of SFA-based vehicles to treat other conditions, aiming to overcome drug delivery limitations."

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

The Role of Topical Cyclosporine A in Ocular Surface Inflammatory Disorders. (PubMed, Semin Ophthalmol) - " After carrying out a literature search on "Cyclosporine A", "Ocular surface disease", "Dry eye", "Vernal keratoconjunctivitis", "Graft versus host disease", "Restasis", "Cequa", "Vevye", "Ikervis", a total of 101 articles were included for this review.  Topical CsA remains a cornerstone therapy in the management of OSID, providing long-term inflammation control, improved ocular surface integrity, and symptomatic relief. Continued research into optimized formulations, combination therapies, and alternative delivery systems may further refine its clinical utility and enhance patient adherence."

Journal • Review • Conjunctivitis • Dry Eye Disease • Graft versus Host Disease • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • Transplant Rejection • Transplantation

Long-Term Safety and Efficacy of a Water-Free Cyclosporine 0.1% Ophthalmic Solution for Treatment of Dry Eye Disease: ESSENCE-2 OLE. (PubMed, Cornea) - "The water-free cyclosporine 0.1% ophthalmic solution was safe and well tolerated during long-term use. The results demonstrated sustained 1-year efficacy, in both signs and symptoms of DED, and may help understand short and long-term healing dynamics in a predominant inflammatory DED population."

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

Harrow Expands VEVYE Access for All Program to ImprimisRx’s Klarity-C Patients (Businesswire) - "Harrow...announced an expansion of its VEVYE Access for All ('VAFA') program to include patients currently prescribed Klarity-C Drops, a compounded cyclosporine 0.1% product manufactured and distributed by ImprimisRx, Harrow’s compounding subsidiary. Since its launch on March 17, 2025, VEVYE Access for All has simplified dry eye therapy for eligible patients by eliminating access barriers like prior authorization and reimbursement delays, providing free home delivery, and offering a no‑questions-asked, money-back guarantee....As a result of today’s announcement, beginning immediately, more than 25,000 patients across the U.S. will be able to convert their Klarity-C prescriptions to VEVYE (cyclosporine ophthalmic solution) 0.1%, an FDA‑approved treatment for the signs and symptoms of dry eye disease, for $59 per bottle (including refills)."

US reimbursement • Dry Eye Disease

Efficacy and safety of water-free cyclosporine ophthalmic solution (SHR8028) in patients with dry eye disease comorbid with autoimmune disease: a post-hoc analysis of a phase III, randomized controlled trial (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 • P3 data • Retrospective data • Dry Eye Disease • Ophthalmology

Water-free cyclosporine ophthalmic solution for dry eye disease: a post-hoc analysis of a phase 3 trial by menopausal status (ARVO 2025) - P3 | "Purpose In a previous phase 3 trial, the water-free cyclosporine ophthalmic solution (SHR8028) was more effective than vehicle in improving total corneal fluorescein staining (tCFS) and symptom control of dry eye disease (DED)...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."

P3 data • Retrospective data • Dry Eye Disease • Ophthalmology