Reproxalap Medicine 13 December 2018 Extended indication Allergic conjunctivitis Therapeutic value No judgement Total cost € 300,000.00 Registration phase Clinical trials Product Active substance Reproxalap Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Allergic conjunctivitis Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Aldeyra Portfolio holder Mechanism of action Unknown Route of administration Ocular Therapeutical formulation Eye drops Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Aldehyde trap antihistamine, Malondialdehyde inhibitors. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Azelastine (0,5 mg/ml, 10 ml) 2-4 dd 1 druppel; bij onvoldoende effect: stop de azelastine en probeer ketotifen (0,25 mg/ml, 5 ml) 2 dd 1 druppel, of olopatadine (1 mg/ml, 5 ml) 2 dd 1 druppel; eventueel cromoglicinezuur (20 mg/ml, 10 ml) 2-6 dd 1 druppel of nedocromil (20 mg/ml, 5 ml) 2-4 dd 1 druppel. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03494504 Additional remarks Expected patient volume per year Patient volume 10,000 - 20,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP-databank Additional remarks Het aantal gebruikers van antihistaminica, lokaal, betrof in 2016 per middel tussen de 10.000-20.000 gebruikers. Expected cost per patient per year Cost € 10.00 - 30.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References GIP-databank Additional remarks De vergoeding per gebruiker van antihistaminica, lokaal, betroffen in 2016 zo'n 10 - 30 euro. Verwacht wordt dat Reproxalap in dezelfde lijn zal liggen. Potential total cost per year Total cost € 300,000.00 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 Sjogren-Larsson syndrome; Uveitis References https://adisinsight.springer.com/drugs/800040586 Additional remarks Other information Additional remarks