Vekacia (ciclosporin ophthalmic) / Santen - LARVOL DELTA

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

Conjunctival T Cell Profile in Allogeneic Hematopoietic Stem Cell Transplant Patients after Instilling Topical Cyclosporine-A 0.1% Cationic Emulsion. (PubMed, Ophthalmol Ther) - P4 | "Superficial conjunctival T cell profile reflects compliance to daily topical Ikervis eye drops and clinical ocular surface parameters in allogenic HSCT patients. Tolerance is comparable to other formulations of topical CsA in the first 12 months."

Journal • Bone Marrow Transplantation • Dry Eye Disease • Graft versus Host Disease • Immunology • Ophthalmology • Transplantation • CD4

CSA2020: Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery (clinicaltrials.gov) - P1 | N=101 | Completed | Sponsor: Campus Bio-Medico University | Active, not recruiting ➔ Completed

Trial completion • Cataract • Immunology • Inflammation • Ocular Inflammation • Ophthalmology

Effectiveness of Topical Cyclosporin A 0.1%, Diquafosol Tetrasodium 3%, and Their Combination, in Dry Eye Disease. (PubMed, J Ocul Pharmacol Ther) - "Patients instilled topical CsA 0.1% (Ikervis; Santen Pharmaceutical Co., Ltd., Japan) once daily and/or DQS tetrasodium 3% (Diquas-S; Santen) six times a day for 12 weeks. Monotherapy with CsA or DQS and CsA/DQS combination therapy all significantly improved the objective signs and symptoms of dry eyes during 12 weeks of treatment. CsA/DQS combination therapy provides an additional benefit in terms of TBUT compared with CsA alone; however, a randomized controlled trial still needs to be performed to confirm this result."

Journal • Dry Eye Disease • Ophthalmology

Ciclosporin A Cationic Emulsion 0.1% for the Management of Dry Eye Disease: Facts That Matter for Eye-Care Providers. (PubMed, Ocul Immunol Inflamm) - "This review summarises data from randomised controlled trials and real-world evidence on the efficacy and safety of ciclosporin A 0.1% cationic emulsion (Ikervis®) for the management of DED...In the most responsive patients, treatment discontinuation is possible with no further substantial relapse over 12 months in over 65% of patients. Transient local ocular effects are the most commonly reported adverse events."

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

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

Enrollment closed • Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology

Cyclosporine A 0.1% Cationic Emulsion in Vernal Keratoconjunctivitis: a clinical experience (BSACI 2022) - "On October 2, 2020, Verkazi"

Clinical • Allergy • Conjunctivitis • Dry Eye Disease • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

USAGE OF CICLOSPORIN EYE DROPS IN PEDIATRIC AGE: CASE REPORTS (ESCRS-WM 2022) - "The usage of immunomodulatory agents such as topical ciclosporin is effective in the long- term treatment, since it is corticosteroid sparing in steroid-dependent patients when other treatments have failed.(3) In Portugal, the commercialized ciclosporin (Ikervis®) is only approved for administration in adults.(4) However, its off-label usage in the pediatric population has shown great benefits...She was treated with tobramycin + dexamethasone and ketotifen with significant improvement...They were both forwarded to a pediatrician specialized in allergies to study them systemically. Conclusion / Take home message: In pediatric patients presenting with corticosteroid dependent VKC the ciclosporin can be a helpful ally in the disease control, avoiding chronic usage of corticosteroids and providing a significant improvement of the clinical status and quality of life of these patients.(3)"

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