Ciclosporine Medicine 05 December 2023 Extended indication Treatment of moderate to severe dry eye disease (keratoconjuctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Ciclosporine Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Treatment of moderate to severe dry eye disease (keratoconjuctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes. Current proprietary name Already available biosimilars / generics Proprietary name Vevizye Manufacturer Novaliq Portfolio holder Novaliq Mechanism of action Unknown Route of administration Ocular Therapeutical formulation Eye drops Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Vevizye is een conserveermiddelvrije, watervrije, ontstekingsremmende en immunomodulerende oogoplossing met 0,1% ciclosporine. Dit betreft een nieuwe formulering van een bestaand middel. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2023 Expected Registration September 2024 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Geregistreerd september 2024. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration References NCT04523129 (ESSENCE 2) (1); NCT04523142 (2) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank. 2024 (1). Additional remarks In 2023 waren er 6.376 gebruikers van ciclosporine (1). De nieuwe samenstelling zal mogelijk een gedeelte van de markt vervangen. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks