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KPI-121

Inveltys

Extended indication Dry eye disease.
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance KPI-121
Domain Neurological disorders
Main indication Eye disorders
Extended indication Dry eye disease.
Proprietary name Inveltys
Manufacturer kala
Route of administration Ocular
Therapeutical formulation Eye drops
Budgetting framework Extramural (GVS)
Additional remarks Pipeline watch 12 januari 2018: STRIDE 1, 2; met not all primary endpoints; mixed results Phase III Interim/Top-line Results. Glucocorticoid receptor agonists.

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date 2018
Expected Registration 2019
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Prednisolon 0,05% en 0,1 % en dexamethason oogdruppels.
Therapeutic value No judgement
Substantiation Mixed results fase III trials, na 15 dagen werden primary endpoints niet allen gehaald (met name in STRIDE-2).
Dosage per administration 0,25% 1 oogdruppel
References STRIDE 1 and 2

Expected patient volume per year

References Onderstaande gegevens zijn op basis van Lifitegrast.
Additional remarks Afhankelijk van de uiteindelijke labelling en plaats in de behandelrichtlijn. Prevalentie van ernstige DED is 2% - 5% (340.000 - 850.000 patiënten). Nog onbekend bij hoeveel patiënten het uiteindelijk ingezet gaat worden, dit is afhankelijk van de therapeutische waarde.

Expected cost per patient per year

Cost 100.00 - 200.00
References GIPdatabank
Additional remarks Verwachte kosten vergelijkbaar met Prednisolon en dexamethason oogdruppels. Kosten per gebruiker 2016 prednisolon €103,50, kosten per gebruiker 2016 dexamethason €183,40.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions ocular pain and inflammation.
References Scrip, clinicaltrials.gov.

Other information

There is currently no futher information available.