Acoltremon Medicine 03 December 2024 Extended indication Treatment for the signs and symptoms of dry eye disease. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Acoltremon Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Treatment for the signs and symptoms of dry eye disease. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Alcon Portfolio holder Mechanism of action Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks TRPM8 protein stimulants. Fabrikant: Alcon Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Kunsttranen Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen fase 3-resultaten bekend. Duration of treatment Frequency of administration Dosage per administration References NCT05285644 (COMET-2); NCT05360966 (COMET-3) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Horizonscan Geneesmidddelen lifitegrast (1). Additional remarks Prevalentie van ernstige DED is 2 tot 5% (340.000 tot 850.000 patiënten) (1). 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks