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

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

Efficacy of water-free cyclosporine ophthalmic solution by severity of dry eye disease: A post hoc analysis of a randomized clinical trial (ARVO 2025) - "Purpose SHR8028 (also known as CyclASol) is a water-free 0.1% cyclosporine ophthalmic solution that has been approved by the Food and Drug Administration for the treatment of the signs and symptoms 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."

Clinical • Retrospective data • Dry Eye Disease • Ophthalmology

Effect of the dry eye drop perfluorohexyloctane and comparator semifluorinated alkanes on the evaporation rate of saline in vitro (ARVO 2025) - "This in vitro study evaluated the impact of chain length on SFA evaporation rate (Revap) and inhibition of Revap of saline by assessing several SFAs including two dry eye drops, one consisting of 100% SFA (perfluorohexyloctane; F6H8; MIEBO®) the other which includes the SFA perfluorobutylpentane (F4H5) as a vehicle (cyclosporine ophthalmic solution 0.1%; CsA 0.1%; VEVYE®)...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."

Preclinical • Dry Eye Disease • Ophthalmology

Harrow Launches VEVYE Access for All (Businesswire) - "Harrow...introduced VEVYE Access for All, a groundbreaking initiative that underscores Harrow’s long‑standing commitment to access and affordability. This program, which is now available through our PhilRx specialty pharmacy partner, guarantees access to VEVYE (cyclosporine ophthalmic solution) 0.1% for eligible patients and health plans for $59, ensuring that every patient can affordably start treatment without delay."

Launch • Dry Eye Disease

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

Journal • Dry Eye Disease • Ophthalmology

Differentiating Between Perfluorohexyloctane Ophthalmic Solution and Water-Free Cyclosporine Ophthalmic Solution 0.1% for Dry Eye Disease: A Review of Preclinical and Clinical Characteristics. (PubMed, Ophthalmol Ther) - "Perfluorohexyloctane ophthalmic solution (Miebo) and water-free cyclosporine ophthalmic solution 0.1% (Vevye) are recently approved treatments for dry eye disease (DED)...The shorter chain length of PFBP enables it to better solubilize cyclosporine and improve drug delivery to ocular tissues. Although both of these ophthalmic drops utilize SFAs, their differences-in physicochemical properties and the mechanisms by which they are understood to intervene in the DED cycle-are important considerations in treatment selection for patients with DED."

Journal • Preclinical • Review • Dry Eye Disease • Ophthalmology

Vevye: “The committee confirmed that all issues previously identified in this application had been addressed”; Dry eye disease (European Medicines Agency) - CHMP Final Minutes of the meeting on 22- 25 Jul 2024: “The committee adopted a positive opinion recommending the granting of a marketing authorisation by consensus together with the CHMP assessment report and translation timetable”

CHMP • Dry Eye Disease • Ophthalmology

Vevye: Newly added patent in Orange Book (Orange Book) - Expiry of patent on Apr 1, 2042

Patent • Ophthalmology

Novaliq and Laboratoires Théa Announce Partnership and EU Approval for Vevizye (Ciclosporin 0.1% Eye Drops Solution) (Businesswire) - "Novaliq...and Laboratoires Théa (Théa)...announce European Commission approval of Vevizye (ciclosporin 0.1% eye drops solution) in Europe and the closing of a partnership under which Théa has acquired the rights to commercialise the product in Europe and selected countries in the Middle East and North Africa (MENA)....The efficacy of Vevizye® for the treatment of dry eye disease was demonstrated by two randomised, multicentre, double-masked, vehicle-controlled studies (ESSENCE-1 and ESSENCE-2)."

EMA approval • Licensing / partnership • 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

Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye Disease (Businesswire) - "Novaliq...announces that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorisation in the European Union for Vevizye, intended for the treatment of moderate to severe dry eye disease in adult patients, which has not improved despite treatment with tear substitutes."

CHMP • Dry Eye Disease • Ophthalmology

A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine (clinicaltrials.gov) - P4 | N=204 | Active, not recruiting | Sponsor: Novaliq GmbH | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Aug 2025 | Trial primary completion date: Nov 2025 ➔ Jul 2025

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

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

A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: Novaliq GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ophthalmology

Vevye: Protection of patents related to formulation composition for treatment of dry eye syndrome until Dec 2030 (Harrow) - Annual Report 2023: Protection of patents related to ophthalmic composition comprising cyclosporine until Sep 2037; Protection of patents related to semiflourinated compounds for ophthalmic administration until Nov 2038; Protection of patents related to topical administration method until Oct 2039

Patent • Dry Eye Disease • Ophthalmology

A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine (clinicaltrials.gov) - P4 | N=200 | Not yet recruiting | Sponsor: Novaliq GmbH

New P4 trial • Dry Eye Disease • Ophthalmology

Water-Free Cyclosporine Ophthalmic Solution vs Vehicle for Dry Eye Disease: A Randomized Clinical Trial. (PubMed, JAMA Ophthalmol) - P3 | "To evaluate the efficacy and safety of SHR8028, a water-free cyclosporine ophthalmic solution, 0.1%, compared with vehicle in Chinese participants with DED...However, dryness score (VAS) was not improved at day 29. ClinicalTrials.gov Identifier: NCT05841043."

Clinical • Journal • Dry Eye Disease • Ophthalmology

Harrow Licenses Canadian Rights to Apotex for Five Branded Ophthalmic Pharmaceutical Products (Businesswire) - "Harrow...and Apotex...jointly announced an exclusive out-licensing agreement under which Apotex will market and distribute VERKAZIA and over-the-counter (OTC) Cationorm PLUS in the Canadian market, and concurrently, pursue market approval in Canada for VEVYE, IHEEZO, and ZERVIATE....Under the terms of the agreement, Apotex licensed exclusive rights and marketing authorizations of the...products in the Canadian market from Harrow..."

Licensing / partnership • Conjunctivitis • Dry Eye Disease • Ophthalmology

Harrow Announces Availability of VEVYE (Cyclosporine Ophthalmic Solution) 0.1%, the First and Only Cyclosporine-Based Product Indicated for Treating Both Signs and Symptoms of Dry Eye Disease (Businesswire) - "Harrow...today announced that VEVYE^® (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, twice-daily (BID) dosed prescription drug based on a 'water‑free' semifluorinated alkane eyedrop technology, is now available in the U.S. – and includes a 100% Money‑Back Guarantee program. VEVYE, uniquely dispensed in a 10 microliter drop, is the first and only cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease (DED)....'We are excited to see VEVYE’s exceptional clinical trial data come to life as U.S. dry eye disease patients are now able to access and experience a highly tolerable product that provides rapid onset of relief and sustained improvement of both signs and symptoms of dry eye disease.'"

US reimbursement • Dry Eye Disease • Ophthalmology

Vevye: “Fast Onset and 12-Month Sustained Improvement”; Dry eye disease (Harrow) - Q3 2023 Results

P3 data • Dry Eye Disease • Ophthalmology

Vevye: Launch for dry eye disease in late 2023 (Harrow) - Q3 2023 Results

Launch • Dry Eye Disease • Ophthalmology

Efficacy And Safety Of A Water-Free Cyclosporine 0.1% Formulation For The Treatment Of Dry Eye Disease: Results From Two Randomized Controlled Studies Essence-1 And Essence-2 (ESCRS 2023) - P2b, P3 | "The ESSENCE-1 and ESSENCE-2 studies showed that treatment with a water-free cyclosporin solution, 0.1% consistently results in early therapeutic effects on the ocular surface compared with vehicle. The responder analyses suggest that the effect is clinically meaningful for the majority of patients in the cyclosporine group. The safety and tolerability profile of CyclASol was beneficial in both studies shown by low rates of installation site reactions and highly comfort ratings."

Clinical • Dry Eye Disease • Ophthalmology

European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol (ciclosporin ophthalmic solution) 0.1% for the Treatment of Dry Eye Disease (Businesswire) - "Novaliq GmbH...today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU)....The clinical development program for the MAA is based on six clinical studies...Results from the two registrational studies, ESSENCE-1 and ESSENCE-2 consistently demonstrated that the product is effective for the treatment of DED."

European regulatory • Dry Eye Disease • Ophthalmology