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KPI-121

Inveltys

Extended indication Ocular pain and inflammation. Om te gebruiken na oogchirurgie.
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance KPI-121
Domain Neurological disorders
Main indication Eye disorders
Extended indication Ocular pain and inflammation. Om te gebruiken na oogchirurgie.
Proprietary name Inveltys
Manufacturer kala
Route of administration Ocular
Therapeutical formulation Eye drops
Budgetting framework Extramural (GVS)
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
Submission date 2018
Expected Registration 2019
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Pred forte, dexamethason oogdruppels
Therapeutic value No judgement
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

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

There is currently nothing known about the expected cost.

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 Dry eye disease
References Scrip, clinicaltrials.gov

Other information

There is currently no futher information available.