Timbetasine acetaat Medicine 03 June 2025 Extended indication Timbetasin acetate monotherapy for treatment of stage 2 or 3 Neurotrophic keratopathy in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Timbetasine acetaat Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Timbetasin acetate monotherapy for treatment of stage 2 or 3 Neurotrophic keratopathy in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Regenerx Portfolio holder Mechanism of action Unknown Route of administration Ocular Therapeutical formulation Instillation fluid Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Solution For Ocular Instillation. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date December 2025 Expected Registration January 2027 Orphan drug No Registration phase Clinical trials 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 In de fase 3 studie (SEER-1) zijn net aan de primaire eindpunten niet gehaald. Er zijn echter wel aanwijzingen voor effectiviteit. Het aantal geïncludeerde patiënten in de studie lijkt te klein waardoor er te weinig power is voor een significant resultaat. Twee nieuwe fase 3 studies met grotere patiëntaantallen lopen op dit moment in Europa en de Verenigde Staten: (SEER-2) en (SEER-3). Er zijn nog geen resultaten bekend uit deze twee studies. Duration of treatment Frequency of administration Dosage per administration References NCT02600429 (SEER-1); NCT05555589 (SEER-2) EUCT 2022-502697-16-00 (SEER-3); Additional remarks Expected patient volume per year Patient volume 3,500 - 4,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks De indicatie is patiënten met stadium 2 en 3 neurotrofe keratopathie (NK). De geschatte prevalentie in de Verenigde Staten van NK is 21,34 per 100.000 mensen. Uitgaande van vergelijkbare prevalenties in Nederland zou dat neerkomen op 3.500 tot 4.000 patiënten. 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