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Ciclosporine

Vevizye

Extended indication Treatment of moderate to severe dry eye disease (keratoconjuctivitis sicca) in adult patients, which
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Ciclosporine
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Eye disorders
Extended indication Treatment of moderate to severe dry eye disease (keratoconjuctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes.
Proprietary name Vevizye
Manufacturer Novaliq
Portfolio holder Novaliq
Route of administration Ocular
Therapeutical formulation Eye drops
Budgetting framework Extramural (GVS)
Additional remarks Vevizye is een conserveermiddelvrije, watervrije, ontstekingsremmende en immunomodulerende oogoplossing met 0,1% ciclosporine. Dit betreft een nieuwe formulering van een bestaand middel.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2023
Expected Registration September 2024
Orphan drug Yes
Registration phase Registered
Additional remarks Geregistreerd september 2024.

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 2 times a day
References NCT04523129 (ESSENCE 2) (1); NCT04523142 (2)

Expected patient volume per year

References GIP databank. 2024 (1).
Additional remarks In 2023 waren er 6.376 gebruikers van ciclosporine (1). De nieuwe samenstelling zal mogelijk een gedeelte van de markt vervangen.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.