KPI-121 Medicine 12 June 2018 Extended indication Ocular pain and inflammation. Om te gebruiken na oogchirurgie. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance KPI-121 Domain Neurological disorders Reason of inclusion Main indication Eye disorders Extended indication Ocular pain and inflammation. Om te gebruiken na oogchirurgie. Current proprietary name Already available biosimilars / generics Proprietary name Inveltys Manufacturer Kala Portfolio holder Mechanism of action Unknown Route of administration Ocular Therapeutical formulation Eye drops Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Pipeline watch 12 januari 2018: Reduced symptoms. Updated Phase III Results. Glucocorticoid receptor agonists. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New medicine ATMP Unknown Submission date 2018 Expected Registration 2019 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Pred forte, dexamethason oogdruppels Therapeutic value No judgement 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 1% References NCT02793817 Additional remarks Twee fase III trials laten effectiviteit van KPI-121 1% zien ten opzichte van placebo. Er zijn geen trials van KPI-121 ten opzichte van bestaande medicatie. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Het verwachte patiëntvolume is afhankelijk van therapeutische meerwaarde. Om hier een goede uitspraak over te kunnen doen zijn meer studies nodig. 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 Yes Indication extensions Dry eye disease References Scrip, clinicaltrials.gov Additional remarks Other information Additional remarks