Vekacia (ciclosporin ophthalmic) / Santen - LARVOL DELTA

Nanotechnological Advances in Ocular Therapeutics: A Narrative Review of Drug Delivery Platforms, Clinical Applications, and Translational Challenges. (PubMed, Nanotechnol Sci Appl) - "Clinically translated examples include cyclosporine A nanomicelle and nanoemulsion formulations, marketed as Cequa (0.09%), Restasis (0.05%), and Ikervis (0.1%), approved for dry eye disease, and a subconjunctival PLGA nanoparticle depot that achieved greater than 20% intraocular pressure reduction sustained over 90 days from a single injection in early clinical evaluation. Lipid-based and polymeric nanocarrier platforms are currently closest to clinical translation, with approved formulations and early-phase trial data supporting meaningful therapeutic advantages over conventional delivery. Realising the full potential of ocular nanomedicine will require addressing residual challenges in long-term ocular safety, manufacturing scalability, and regulatory compliance, particularly for posterior-segment applications, where non-invasive topical delivery remains largely at the preclinical stage."

Journal • Review • Age-related Macular Degeneration • Conjunctivitis • Diabetic Retinopathy • Dry Eye Disease • Eye Cancer • Glaucoma • Inflammation • Keratitis • Macular Degeneration • Ocular Infections • Ocular Inflammation • Oncology • Ophthalmology • Retinal Disorders • Retinoblastoma • Retinopathy of Prematurity • Solid Tumor

Treatment of Ocular Surface Inflammations (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Semmelweis University

New trial • Allergy • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Physicochemical Fingerprinting of Cyclosporine A Ophthalmic Emulsions as a New Approach Methodology for Clinical Tolerability. (PubMed, J Ocul Pharmacol Ther) - "Restasis exhibited substantially higher viscosity than Ikervis across all shear rates, whereas Ikervis and the CMC reference showed comparable high-shear viscosity despite markedly different reported tolerability-a viscosity-discomfort dissociation. The proposed framework is hypothesis-generating rather than mechanistically conclusive; it is intended to support future targeted validation studies rather than replace clinical evaluation. GC-MS may serve as a useful complementary fingerprinting tool within NAM/IATA-aligned ophthalmic formulation assessment."

Journal • Ophthalmology • Pain

Artificial tears and immunosuppressive therapy for immune-mediated disorders of the ocular surface (PubMed, Vestn Oftalmol) - "In the acute stage or during exacerbations of severe immune-mediated lesions, the drug of choice is the glucocorticosteroid (GCS) dexamethasone...Although the use of cyclosporine A, including in the form of a cationic emulsion (Ikervis), is considered ineffective for most forms of dry eye disease, it may be used in a selected group of patients with moderate immune keratoconjunctivitis...As for mandatory tear substitution therapy in this patient population, combined formulations containing hyaluronic acid and the reparative agent dexpanthenol appear promising. The composition of Stillavit Intensive provides reliable hydration of ocular surface tissues due to sodium hyaluronate 1.8 mg, additional anti-inflammatory effects mediated by sodium chondroitin sulfate, and regeneration of the conjunctival and corneal epithelium through D-panthenol 50.0 mg."

Journal • Review • Conjunctivitis • Dry Eye Disease • Immunology • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Tear cytokine dataset in patients with allogeneic stem cell transplant treated with topical cyclosporine. (PubMed, Data Brief) - "This article showed the data of ocular clinical parameters, tear fluid cytokines, and topical cyclosporine-A 0.1% (Ikervis®) compliance in allogeneic hematopoietic stem cell transplant (allo-HSCT) patients. Study visits were conducted at 3-5 weeks pre-allo-HSCT (screening), pre-allo-HSCT, and 3/6/12 months post-allo-HSCT, with data collected at each time point. At each visit, tear samples were assessed for 96 cytokines by the Proximity Extension Assay O-linked target 96 platform."

Journal • Bone Marrow Transplantation • Transplantation

LT1695-201: A Study to Compare the Effectiveness and Safety of T1695 (0.1% Tacrolimus) Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis (clinicaltrialsregister.eu) - P1/2 | N=72 | Not yet recruiting | Sponsor: Laboratoires Thea

New P1/2 trial • Conjunctivitis • Dry Eye Disease • Ocular Infections • 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

Dupilumab-Associated Symblepharon Case Report – Should We Be Monitoring These Patients? (ESCRS 2024) - "He previously had issues taking oral Ciclosporin and topical Ikervis was therefore avoided. Instead, he was given another course of topical steroid (Softacort) with Olopatadine... A common, recognised side effect (>1/100 to <1/10) of Dupilumab is an inflammatory conjunctivitis. It is possible that repeated episodes can lead to symblepharon formation. Based on our reported case, we propose that patients who develop Dupilumab-associated conjunctivitis should be monitored in the eye clinic regularly to monitor for symblepharon formation, with early therapy substitution if appropriate."

Case report • Clinical • Conjunctivitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Dry Eye Disease After Epidemic Keratoconjunctivitis As A Mask Of Sjogren's Syndrome. (ESCRS 2024) - "Due to of lack of improvement, she was referred to the Rheumatology Clinic, in which Sjogren's syndrome was diagnosed, general medications were started (hydroxychloroquine, oral steroids).The targeted treatment was introduced (Ikervis - ciclosporin 0.1% eye drops, 10% acetylcysteine eye drops, preservative-free artificial tears)... Autoimmune disorder should be considered in the differential diagnosis of DED.The diagnosis and treatment of DED is problematic, but treated multidisciplinary produces better results."

Conjunctivitis • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Efficacy Of Long-Term Cyclosporine Treatment Of Patients With Severe Dry Eye Disease Syndrome (ESCRS 2024) - "1. Patients receiving therapy with the drug Ikervis experienced a great improvement in the symptoms present, and test results improved. 2."

Clinical • Dry Eye Disease • Ophthalmology

Frequency of Topical Immunomodulatory and Immunosuppressive Therapies for Ocular Chronic Graft-versus-Host Disease. (PubMed, J Clin Med) - "A total of 92.63% (88/95) were primarily treated with ciclosporin A 0.1% as Ikervis®, of whom at least one third did not continue the therapy because of intolerable side effects during follow-up and received alternative topical formulations. Our data show that patients with ocular cGVHD mostly need topical therapy including anti-inflammatory agents despite systemic immunosuppressive therapy. In our cohort, 80% of patients received topical steroids, and more than 90% received topical ciclosporin A eye drops, which were tolerated by only two thirds of patients due to side effects."

Immunomodulating • Journal • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Inflammation • Ocular Inflammation • Ophthalmology

The place of ciclosporin A cationic emulsion 0.1% in the therapy of xerophthalmia (PubMed, Vestn Oftalmol) - "A step-by-step approach to DED treatment involves early initiation of anti-inflammatory therapy, including instillation of cyclosporine A (CsA). However, recommendations for the use of topical CsA in clinical practice are limited. This article presents an expert consensus on practical recommendations for the management of patients with DED, including indications, time of initiation and duration of CsA therapy, comparison of CsA forms currently registered in the Russian Federation, as well as issues of patient education."

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

Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis (clinicaltrials.gov) - P4 | N=17 | Completed | Sponsor: Santen SAS | Unknown status ➔ Completed | N=33 ➔ 17

Enrollment change • Trial completion • Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology

Short-Term Efficacy of Ophthalmic Cyclosporine: A 0.1% Cationic Emulsion in Dry Eye Patients Assessed Under Controlled Environment. (PubMed, Ophthalmol Ther) - P4 | "Topical CsA-0.1% CE improved DED signs and symptoms after 1 month of treatment under controlled environmental conditions. Future studies should confirm the benefit of CsA-0.1% CE in desiccating stress environments."

Clinical • Journal • Dry Eye Disease • Ocular Inflammation • 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

Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (NOVATIVE): A Phase II/III, Multicenter, Double-masked, Randomized Study of 0.05% Cyclosporine A and 0.1% Ophthalmic Cationic Emulsion Versus Vehicle in Patients With Vernal Keratoconjunctivitis. (PubMed, Clin Ther) - P2/3 | "Although treatment with 0.05% and 0.1% CsA-CE showed clinical efficacy in alleviating keratitis and itching as early as week 1, with sustained benefit through 1 month, the primary efficacy end point was not met. These findings informed the design of the Phase III trial of 0.1% CsA-CE (Vernal Keratoconjunctivitis Study)."

Journal • P2/3 data • Conjunctivitis • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin) (clinicaltrials.gov) - P3 | N=350 | Completed | Sponsor: Santen SAS | Active, not recruiting ➔ Completed

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

The Impact of Accelerated Regulatory Approval on Health Technology Assessment: An Evaluation of Orphan Drugs in Four Markets (ISPOR-EU 2023) - " Five ODs (Tegsedi, Verkazia, Onpattro, Evrysdi and Takhzyro) were identified. ODs granted accelerated RA may have faster HTA outcomes in Canada and France, while this status does not seem to impact HTA in England and Germany. No relationship was found between accelerated approval and the applied threshold for willingness to pay. *From evaluation consultation to recommendation."

Orphan drug

Use Of Ciclosporin A 0.1% In The Management Of Ocular Surface Diseases: A District General Hospital Experience. (ESCRS 2023) - "Our cohort suggests that Ikervis® was effective and well tolerated in majority of patients in the treatment of DED and OSID."

Clinical • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Exploring the Therapeutic Potential of Cyclosporine for Ophthalmic Indications by Novel Carrier Systems. (PubMed, Crit Rev Ther Drug Carrier Syst) - "However, Restasis®, Cequa®, and Verkazia® are the marketed formulations that have been approved by U.S. Food and Drug Administration, whereas Cyclokat® and Ikervis® by the European Medicines Agency. Although these medications are in use, they are associated with severe discomfort and poor patient compliance. This review gives an overview regarding current formulations available in the market, the products in pipeline and the recent advances undertaken for improving ocular delivery of CsA for various ophthalmic indications."

Journal • Ophthalmology

Preclinical characterization of water-free cyclosporine eye drops - factors impacting ocular penetration ex vivo and in vivo. (PubMed, Eur J Pharm Biopharm) - "Although the efficacy of Cyclosporine A (CsA) in the management of ocular inflammation is well-demonstrated, ocular delivery remains challenging due to its hydrophobic nature. Interestingly, in vivo the CsA concentration in cornea, conjunctiva and lacrimal glands observed after administration of the F4H5 formulation (AUC: 7,741 ± 1,334 ng.h.g, 1,313 ± 291 ng.h.g, 48.2 ± 26.3 ng.h.g) and F4H5/EtOH both at a reduced dose of 11 µl (AUC: 9,552 ± 1,738 ng.h.g, 1,679 ± 285 ng.h.g, 50.3 ± 21.1 ng.h.g) was similar or even greater than what was observed on administration of 50 µl Ikervis (AUC: 9,943 ± 1,413 ng.h.g, 2,069 ± 263 ng.h.g, 30.6 ± 18.4 ng.h.g). Thus, F4H5-based eyedrops were shown to deliver CsA more efficiently to anterior ocular tissues at a reduced dose in comparison to Ikervis, reducing dose wastage and minimizing any potential systemic side effects."

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

Cyclosporine ophthalmic emulsion (Verkazia) for vernal keratoconjunctivitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Modern possibilities of pathogenetically oriented therapy for dry eye syndrome (PubMed, Vestn Oftalmol) - "Taking into account the immunosuppressive effect of cyclosporine A, which is realized through hindering the activation of T-lymphocytes in the tissues of the ocular surface, its topical application in DES has a pronounced pathogenetic focus. According to numerous clinical studies, Ikervis instillations can improve the effectiveness of complex therapy in patients with DES (especially secondary to Sjögren syndrome, Stevens-Johnson syndrome, graft-versus-host disease), with allergic diseases of the cornea and conjunctiva (spring, atopic corneal conjunctivitis), with corneal transplant disease, and other similar conditions. The high efficacy and safety of Ikervis constitute the reason to recommend it for wide clinical use."

Journal • Allergy • Conjunctivitis • Dry Eye Disease • Graft versus Host Disease • Immunology • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • Steven-Johnson Syndrome • Transplantation

Clinical Outcomes of Topical 0.1% Ciclosporin Cationic Emulsion Used on Label in Children with Vernal Keratoconjunctivitis. (PubMed, Ophthalmol Ther) - "Our findings confirm that topical CsA-CE is an effective on-label option for children with VKC in the real-life setting. In our pediatric patient population, CsA-CE provided good clinical outcomes with a limited need for rescue medication, and it was well tolerated by almost all patients, including those who were intolerant to galenic formulations."

Clinical data • Journal • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Pediatrics

Conjunctival T cell profile after instilling Topical Cyclosporine-A 0.1% cationic emulsion in Allogeneic Haematopoietic Stem Cell Transplant patients (ARVO 2023) - "Purpose To profile conjunctival T cell populations in Allogeneic Haematopoietic Stem Cell Transplant patients after instillation of daily Topical Cyclosporine-A (CsA) 0.1% cationic emulsion (Ikervis), and to evaluate patients’ tolerance to these eyedrops...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 • Dry Eye Disease • Ophthalmology • CD4