Ciclosporine Medicine 05 December 2023 Extended indication Treatment of Signs and Symptoms of Dry Eye Disease Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Ciclosporine Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Treatment of Signs and Symptoms of Dry Eye Disease Current proprietary name Already available biosimilars / generics Proprietary name CyclASol 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 CyclASol is a preservative-free, water-free, anti-inflammatory and immunomodulating ophthalmic solution, containing 0.1% cyclosporine. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2023 Expected Registration September 2024 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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